The Continuous Perfusion Sensing Technology Platform by MY01 is
designed to provide objective data to empower trauma teams in
making faster and more informed decisions, especially in managing
acute compartment syndrome.

Steps for Usage

Ensure the device is properly charged or connected to a power
source.

Place the device on the patient’s affected area for continuous
monitoring.
Review the real-time data provided by the device to track
disease progression.

Use the objective data points to make informed decisions
regarding the need for interventions like fasciotomy.
Monitor trends in pressure readings to understand patient
progression and determine appropriate care levels.

Clinical Benefits

The device helps in early detection of acute compartment
syndrome, reducing the risk of irreversible muscle damage and nerve
injury due to delayed diagnosis and treatment.

Frequently Asked Questions (FAQ)

Q: How does the Continuous Perfusion Sensing Technology
Platform help in trauma care?

A: The platform provides real-time, objective data to trauma
teams, enabling faster decision-making and proactive monitoring of
patients, especially in cases of acute compartment syndrome.

Q: What are the consequences of late diagnosis and treatment of
acute compartment syndrome?

A: Delayed diagnosis can lead to irreversible muscle damage,
nerve injury, and in severe cases, may result in amputation,
carrying significant costs and medicolegal risks.

“`

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The Continuous Perfusion Sensing Technology Platform
Value Analysis

Table of Contents
03 Company Overview 04 Clinical Challenge 07 The Continuous Perfusion Sensing
Technology Platform
10 Competitive Landscape 11 Clinical Benefits 14 Clinical and Preclinical Evidence 18 Reimbursement 19 Regulatory Clearances 20 Training and Education 21 Sources

MY01 Value Analysis | Table of Contents

Company Overview

Founded in 2019 Based in Montreal, QC

About MY01
MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Our breakthrough technology is designed to empower trauma teams with objective data to make faster, more informed decisions. Specializing in the management of acute compartment syndrome, MY01 enables proactive monitoring, early intervention, and improved communication across the care team.
The Value We Provide
While clinical judgment remains essential, the Continuous Perfusion Sensing Technology (CPST) Platform aims to transform trauma programs by converting complex biological signs into dynamic, actionable, real-time data to facilitate better decision-making. With our CPST Platform (see-past), clinicians can visualize objective and continuous disease progression, empowering healthcare facilities to match the needs of injured patients with appropriate levels of care.

Highest Quality of Outcomes
· 2,000 use cases · Reduced time to diagnoses
— 5 hours earlier than clinical signs · 100% sensitivity and specificity

Optimized Clinical Workflow
· Seamless integration into hospital workflows
· Faster patient assessments · Nerve block usage without
compromise · Scheduled OR time

Reducing Risk, Supporting Documentation
· Time-stamped compartment pressure data
· Objective record of care · Mitigated medicolegal risks

OUR MISSION
To enhance the quality and outcomes of trauma care by utilizing advanced technology to minimize variation in care — delivering actionable insights driven by real-time, objective data.

“Fasciotomies are not benign procedures, so you want to be confident the patient absolutely needs one. The MY01 device gives objective data points to help you feel confident in making that decision.”
Charles Moon, MD Cedar Sinai Hospital, Los Angeles

“Ultimately, the device aids in being able to understand where patients are on the spectrum of progression and whether or not they would benefit from a fasciotomy. In cases of high risk patients, it’s really helpful to have consistent pressure readings and to be able to monitor trends when you don’t have a full patient history.”
Hans Van Lancker, MD, FRCSC, FAAOS Cambridge Health Alliance

MY01 Value Analysis | Company Overview

Clinical Challenge

Compartment Syndrome is a Time Sensitive Problem

Compartment syndrome is a true orthopaedic emergency 1. Compartment syndrome is a relatively common but potentially devastating complication of fractures about the knee and tibial shaft (OTA 33,41,42) 2, 3. Compartment Syndrome develops progressively after trauma – requiring close monitoring and serial physical exams. Serial physical exams have proven to have poor specificity and sensitivity. The physical signs can be missed or attributed to other aspects of injury 4, 5. Rapid diagnosis followed by prompt surgical decompression via a fasciotomy is critical to achieving a favorable outcome 6-8.

The most important determinant of outcomes from acute compartment syndrome after an injury is time to diagnosis8,9. Muscle necrosis may occur within 2 hours of injury in as many as 35% of patients with acute compartment syndrome 3. The difference between foot numbness (5.36h) and foot drop (7.25h) can be as little as 2-3 hours 9. The severity of muscle necrosis and nerve injury worsens with the delay in performing

Missed diagnosis and treatment (late fasciotomy) can have catastrophic consequences for the patient with 5.7% of all cases leading to amputation 10. Amputations carry a lifetime cost of over $500,000 and significant medicolegal liability risk to the surgeon and hospital 11.

Time is Muscle Muscle Damage

Reversible Damage (EARLY)

Possible Irreversible Damage

Irreversible Damage (+12hrs)

An acute compartment syndrome lawsuit rules in favor of the patient 33-55% of the time with damages awarded for litigation averaging over $1,550,000 . 12-14
Endorsements 15

Timing of Clinical Signs

Pain Out of Proportion (EARLY)

Pain on Passive Stretching

Pulselessness Paresthesia Pallor

Recommended by an expert panel based on published peer-reviewed literature.

“Evidence supports the use of repeated/continuous intracompartmental pressure monitoring and a threshold of diastolic blood pressure minus intracompartmental pressure >30 mmHg to assist in ruling out acute compartment syndrome.”

“In the absence of reliable evidence, it is the opinion of the work group that without a dependable clinical examination (e.g. in the obtunded patient), repeated or continuous intracompartmental pressure measurements are recommended until acute compartment syndrome is diagnosed or ruled out.”

Published by

METRC
Major Extremity Trauma Research Consortium

Endorsed by

MY01 Value Analysis | Clinical Challenge

35.1 35.1

Patient Outcome is Determined by Time to Diagnosis
The Coordinated Research on Compartment Syndrome (CROCS) group developed a classification of the outcomes of acute compartment syndrome, validating 5 grades related to the timing of intervention, with each successive grade associated with increasing delay in diagnosis and increased morbidity16. The classification used data from previous compartment pressure studies to quantify the categories as follows:

Grade 1
Primary Closure or early delayed closure (within 1-2 days), without any evidence of acute compartment syndrome (prophylactic fasciotomy, no muscle necrosis)
Grade 2
Delayed Primary Closure – Acute Compartment Syndrome with post-ischemic swelling, none to minimal necrotic muscle

Grade 3
Delayed primary closure needing advance wound closure techniques – some muscle necrosis in 1 or 2 compartments (split thickness skin graft or flap, local rotation flap, extended VAC coverage to minimize swelling)
Grade 4
Limb Salvage or Significant Necrosis in greater than 2 compartments

Grade 5
Amputation

Fasciotomies Are Not Benign Procedures
To minimize the risk of missed or delayed diagnoses, many physicians err on the side of caution by performing prophylactic fasciotomies for patients suspected of having compartment syndrome. However, fasciotomies carry significant risks and complications. These include prolonged hospital stays, surgical site infections, the need for further surgical interventions for delayed wound closure, and an overall increase in healthcare costs 17, 18. Patients who undergo fasciotomies for tibial fractures experience an average increase in hospital stay length from 6 to 14 days, doubling their hospitalization costs to approximately $79,000, compared to $34,000 for patients without fasciotomies 17, 18.
The complications of fasciotomies extend beyond cost, as surgical site infections occur in up to 25% of cases, resulting in an average additional cost of $23,466 per case 19. Moreover, these infections and prolonged recovery times may lead to other long-term issues, such as delayed fracture union, non-union, or chronic functional deficits, which require further medical and surgical management. As such, while prophylactic fasciotomies aim to avoid catastrophic outcomes of missed compartment syndrome, they come at a high cost to both patients and healthcare systems.
History of Continuous Compartment Pressure Monitoring
The development of continuous compartment pressure monitoring (CCPM) has marked a significant advancement in the diagnosis and management of acute compartment syndrome (ACS). Early efforts to measure intracompartmental pressure were pioneered by groups like McQueen et al., who demonstrated that CCPM significantly improves diagnostic sensitivity and specificity for acute compartment syndrome 20. Their work established the utility of continuous monitoring in differentiating true acute compartment syndrome cases from false positives, reducing unnecessary fasciotomies, and minimizing long-term complications like muscle necrosis and chronic pain 21.

MY01 Value Analysis | Clinical Challenge

35.1 35.1

History of Continuous Compartment Pressure Monitoring (CONT’D)
One of the key achievements of McQueen’s research was documenting the sensitivity (94%) and specificity (98%) of CCPM, setting it apart as a gold standard for objective diagnosis in at-risk patients 20. By reducing diagnostic ambiguity, their work highlighted how CCPM could prevent the overuse of fasciotomies, a common challenge when relying solely on clinical symptoms. However, despite these advancements, barriers remain to its widespread adoption. The limitations of CCPM include the perceived complexity of the monitoring equipment, the need for rigorous training of medical staff, and potential discomfort for patients undergoing prolonged monitoring.
Today, while CCPM remains the most reliable method for diagnosing acute compartment syndrome, its implementation is not as widespread as its clinical utility suggests. Reasons for this include clinician reliance on traditional diagnostic methods, a lack of standardized protocols for monitoring, and concerns about cost and resource allocation in certain healthcare settings. Overcoming these challenges will require targeted education on the benefits of CCPM, streamlined device usability, and integration into routine care protocols to fully realize its potential in improving outcomes for acute compartment syndrome patients.
MEMS vs Fluid-Based CCPM
MEMS-based (Micro-Electro-Mechanical Systems) continuous intracompartmental pressure monitors provide clear technical advantages over traditional fluid-based pressure monitors in the management of acute compartment syndrome. These devices achieve higher accuracy in pressure measurement due to advanced sensor technology and digital output 22. Additionally, they maintain performance stability under varying physiological conditions, showing minimal sensitivity to body temperature fluctuations, position changes, and dielectric changes.
The design of MEMS-based monitors as self-contained units simplifies the setup process, reducing the risk of errors associated with assembly or component malfunction. Furthermore, the self-calibration feature of these devices ensures consistent and reliable readings over time, while also reducing the risk of user error during calibration–a common issue with manual calibration in fluid-based systems.
The inclusion of Bluetooth technology allows for easy connectivity to digital devices, enabling continuous monitoring, graphical representation of pressure data, and remote data display. This feature aids in tracking disease progression and adjusting treatment plans, while also improving data accessibility for healthcare providers. Overall, MEMS-based continuous intracompartmental pressure monitors offer a reliable, user-friendly, and technologically advanced solution for timely and reliable pressure monitoring in acute compartment syndrome management.

MY01 Value Analysis | Clinical Challenge

The CPST Platform
What is the CPST Platform?
MY01’s Continuous Perfusion Sensing Technology is a platform intended to empower trauma teams to deliver faster, more consistent, and higher-quality care backed by objective data. This platform consists of:

1 The MY01 Continuous Compartment Pressure Monitor
A microelectromechanical system-based sensor (MEMS) that continuously measures intramuscular pressure. Designed to support early and objective diagnosis of compartment syndrome, it provides up to 18 hours of real-time data.
2 The MY01 Mobile Application
Stores and displays identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculates critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician.
3 The MY01 Base Station
Streamlined bedside mobile cart system, set up for ease of use and optimized workflow in trauma settings.

MY01 Value Analysis | The CPST Platform

35.1 35.1

Highest quality of outcomes

Optimizing clinical worflow

Financial optimization

· 5-hour earlier diagnosis · 100% sensitivity and specificity · No missed cases or false
positives
· Improved surgical outcomes · Decrease for STSG from 50%
to 15%

· 18-hour continuous monitoring · 6x more accurate than other
devices · Real-time pressure data via
app/cloud sync · FDA cleared, CE and Health
Canada licensed · Easy-to-use

· 2.8K$ savings per patient · Shorter LOS by 2.73 days
per patient
· Reduced unnecessary fasciotomies
· Net monetary benefit · Improved resource allocation

Technology Overview MEMS
The MY01 Continuous Compartment Pressure Monitor uses a patented intuitive insertion mechanism to deliver reliable MicroElectroMechanical Systems (MEMS) technology directly within the muscle.

MEMS is a miniature machine that consists of: · A central unit that processes data (integrated circuit
such as microprocessor) · Microsensors, MicroActuators, Microelectronics,
MicroStructures · Physical dimension ranging from several millimeters
to less than 1m.
Through the use of MEMS technology, the MY01 device is proven to be six times more accurate than fluid-based pressure monitors cleared by the FDA in the 1980s. 22
Specs

Biocompatable, Waterproof Film

to device body

2 Processing Unit

Transmits pressure

info from the sensor to device body.

MEMS Sensor

Measures changes in pressure.

Insertable

Flex

length

Width

Height

Device size (incl. introducer)

Width

Depth

Pressure monitor

Height Width Depth

118.3 mm 2 mm 200 mm 63.5 mm 30 mm 178.9 mm 39.9 mm 20.3 mm

MY01 Value Analysis | The CPST Platform

35.1 35.1

Product Guide
For a full set of instructions, follow this link or scan the QR code to read the user manual of your selected item.

ITEM CPST Platform
Continuous Compartment Pressure Monitor MY01 Mobile Application
MY01 Base Station Mobile Device Cart Companion Tablet

SKU MY01-CPST MY01-0001 MY01-APP
MY01-CART MY01-TBLT

At the heart of the CPST platform is the MY01 Continuous Compartment Pressure Monitor, a single-use, self-calibrating device inserted into the affected extremity. Data is generated by the embedded MEMS pressure sensor, capturing changes over time.
These readings are transmitted via Bluetooth to the MY01 Mobile Application, allowing visualization of a trend over time rather than relying on single pressure measurements, removing the need to manually record data.
To further streamline workflow and ensure immediate access to data, the MY01 Base Station combines the Mobile Device Cart and the Companion Tablet into a mobile bedside unit, including up to two MY01 Continuous Compartment Pressure Monitor boxes. The MY01 Base Station supports consistent access across shifts and staff, enhancing clinical adoption, and reducing variability in how the system is used.

2 The MY01 Base Station
35.1

3 MY01 Cloud

1
MY01 Continuous Compartment Pressure Monitor

4 MY01 Mobile Application
35.1

35.1

MY01 Value Analysis | The CPST Platform

Competitive Landscape

There are currently only a few devices that use

MY01

STIC

A-line

compartment pressure measurements to manage compartment syndrome, such as the STIC Moni-

Single-use

tor (formerly made by Stryker and currently sold Quick to deploy

through C2Dx) and the A-line pressure transducer.

Continuous

These devices have not been improved upon for more than 20 years, which has led to erroneous values in clinical settings.

Accurate
Care-team collaboration

Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome 22
The study compared three devices–Synthes, Stryker, and MY01–for measuring intracompartmental pressures in a pre-clinical rat model of abdominal compartment syndrome. It assessed their precision, sensitivity, and accuracy relative to a high-precision reference gauge (METEK).
Key Findings

Accuracy and Precision
· The MY01 device was significantly more accurate and precise than Synthes and Stryker, showing a 670% superior precision in linear regression analysis.
· MY01 closely tracked reference pressures, while Synthes and Stryker exhibited significant deviations, drifts, and errors.

Device Performance
· Synthes and Stryker struggled with temperature variations, dielectric changes, and calibration errors.
· The Stryker device often failed at pressures > 30 mmHg, rendering it less reliable for continuous monitoring.
· MY01 demonstrated robust performance, maintaining accuracy and showing resistance to temperature or environmental changes.

Technological Advancements
· MY01 utilizes a Micro-Electrical-Mechanical System (MEMS) sensor capable of detecting minute pressure changes (±0.008 mmHg).
· It supports continuous real-time monitoring and provides wireless data transfer to healthcare providers.

Clinical Implications
· MY01 utilizes a Micro-Electrical-Mechanical System (MEMS) sensor capable of detecting minute pressure changes (±0.008 mmHg).
· It supports continuous real-time monitoring and provides wireless data transfer to healthcare providers.

Measure Pressure (mmHg)

10 15

25 30

5 10 15 20 25 30 35

Reference Gauge (mmHG)

MY01

Stryker

Synthes

Ref

MY01 Value Analysis | Competitive Landscape

Clinical Benefits

Improved Clinical Decision Making
Clinical findings for Acute Compartment Syndrome (ACS) are inherently subjective, leading to variability and potential inaccuracies in diagnosis. In a single trauma hospital, the diagnosis rates for Acute Compartment Syndrome in patients with tibial fractures have been shown to vary widely, ranging from 2% to 24% 23. This inconsistency highlights the challenges faced by clinicians relying solely on traditional diagnostic methods. The MY01 Continuous Perfusion Sensing Technology (CPST) Platform addresses these issues by providing objective, real-time data that enhances diagnostic accuracy and reduces reliance on subjective clinical assessments. Data from MY01 clinical trials further underscores the value of this innovative approach. Hypervariability in pain levels, which often complicates Acute Compartment Syndrome diagnosis, was confirmed across trials, demonstrating the need for a more reliable diagnostic parameter 24.

Pain Score (VAS)

Potential for unncecessary fasciotomies
10
5
Potential for late or missed
diagnoses
0 No CS CS

The MY01 device offers a clear perfusion pressure cutoff that distinguishes patients with Acute Compartment Syndrome from those without, ensuring timely and accurate diagnoses. Moreover, MY01 clinical studies have shown that the time to diagnosis is reduced by an average of five hours compared to standard care for patients not monitored for intracompartmental pressure. This earlier intervention can be critical in preventing complications and improving outcomes.

Non-Monitoring Monitoring 15

25.8
-5h 20.6

Time to Diagnosis (h)

In addition to accelerating diagnosis, the MY01 CPST Platform has demonstrated a significant impact on patient management and outcomes. Continuous pressure measurements have been shown to reduce complications related to wound management, including the risks associated with delayed or unnecessary fasciotomies. By streamlining the diagnostic process and providing precise, actionable data, the MY01 30 CPST Platform empowers clinicians to make informed decisions quickly, improving both patient outcomes and healthcare efficiency.

Cost-Effective Solution

Early, reliable, continuous compartment pressure monitoring in at-risk patients can drive significant savings when compared to single-point measurements with clinical findings. Only continuous pressure measurements enable a stable reference, which can be used to correlate the changes in clinical findings in order to reduce unnecessary fasciotomies while de-risking delayed diagnosis. Catching compartment syndrome early and reducing unnecessary fasciotomies contribute to decreasing the cost of care for patients at risk of developing compartment syndrome.

MY01 Value Analysis | Clinical Benefits

35.1 35.1

Continuous compartment pressure monitoring (CCPM) offers transformative economic and clinical advantages in the management of acute compartment syndrome (ACS). By enhancing diagnostic accuracy, CCPM significantly reduces unnecessary prophylactic fasciotomies, which add an average of $27,789 per procedure 25. The use of CCPM also decreases hospital length of stay by 2.73 days per patient, creating substantial cost savings and optimizing healthcare resources. With a net monetary benefit (NMB) of $2,800 over 60 days and $4,086 over a lifetime, CCPM delivers measurable economic value while simultaneously improving patient care. 25

In addition to its immediate cost-saving benefits, CCPM drives long-term improvements in patient outcomes by reducing complications and enabling better allocation of healthcare resources. Its high specificity in diagnosing acute compartment syndrome minimizes the risks of unnecessary interventions and associated morbidities, positioning it as a powerful tool for effective acute compartment syndrome management. The technology’s ability to streamline treatment pathways and enhance care quality establishes it as a critical innovation for healthcare systems striving to balance cost-efficiency with exceptional patient outcomes.

100 Evaluate Clinical Signs only

30 Are Flagged by CareTeam and Consulted

20 Will get a Fasciotomy

14 Prophylactic Fasciotomies

6 Fasciotomy within 0 6 hrs
Ischemia

$6.64M $6.32M

NET SAVINGS OF
$280,000 total $2,800/patient

100 Proactive Continuous Monitoring with MY01

6 Will get flagged by Care Team with upward
trending pressure & Clinical Diagnosis

6 Will get a Planned 6 Fasciotomy within 0 6

Fasciotomy

hrs Ischemia

Proactive Monitoring with MY01

Protocol-based Management of Acute Compartment Syndrome
Rockwood and Green’s Fractures in Adults is an essential reference for treating various fractures in adult patients. Volume 1 of the 10th Edition is designed to ensure healthcare professionals are fully equipped with modern techniques and technologies essential for effective fracture management in orthopaedics.

It includes recommendations for addressing patients at risk of developing Compartment Syndrome, highlighted in Chapter 17. The section on diagnosing Compartment Syndrome (pg. 580) highlights the importance of MY01’s Continuous Compartment Pressure Monitoring in allowing earlier recognition of rising trends in pressure, often before irreversible tissue or nerve damage occurs.

The “Authors’ Preferred Treatment” algorithm for Acute Compartment Syndrome (pg. 591) advocates the use of continuous pressure monitoring, based on a validated protocol established at McGill University and the Royal Infirmary of Edinburgh.

MY01 Value Analysis | Clinical Benefits

35.1 35.1

The McGill-Edinburgh Protocol

Fasciotomy

No Fasciotomy
Continue monitoring & examination

Clear clinical P <30mmHg signs of ACS for 2 hours

Examination positive Ps or
concerns
Trend worsening

Examination no evidence
of ACS

Orthopaedic or

trauma team

notification

Continuous

Compartment

Pressure Monitor Systemic pressure

Insertion in most at risk
region

documentation

Examination positive Ps or
concerns
Trend worsening

Trend improving Continue to monitor

High IMP Low P (<30mmHg)

High IMP Normal P (>30mmHg)

Low IMP Normal P (>30mmHg)

P>30mmHg for >24 hours*
Discontinue monitoring

*Instructions about the use of the MY01 Continuous Compartment Pressure Monitor can be found at https://my01.io/my01-device-and-app-repository/

At-Risk Patient Profiles

High-energy injury 41, 42 B or C, 12, 22 C

Obtunded patients with injury
Revascularization

Trauma + anticoagulants Trauma + cirrhosis

Crush injury

In conclusion, this evidence-based approach has been adopted by those leading institutions to complement their diagnostic framework, leveraging its ability to 1) identify rising intracompartmental pressures early, even before clinical signs manifest, and 2) provide continuous, reliable data that empowers clinicians to make informed decisions about the need for surgical intervention.

MY01 Value Analysis | Clinical Benefits

Clinical and Preclinical Evidence

Preclinical Data

Paper
Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome., Merle, G., M. Comeau-Gauthier, V. Tayari, M. N. Kezzo, C. Kasem, F. Al-Kabraiti, C. Laverdiere, G. Xereas and E. J. Harvey (2020). “” Military Medicine 185(Supplement_1): 77-81. (As Presented at SICOT)

Description
Three devices (Synthes, Stryker, and MY01) were compared in a pre-clinical rat compartment syndrome simulation. Simultaneous measurements of intracompartmental pressures allowed concurrent comparison among all devices. Results: Large variations from the reference values are seen with the Synthes and Stryker devices. Variances are large in these two devices even under ideal conditions. The MY01 device was the truest indicator of reference pressure in this acute compartment syndrome model (over 600% more accurate).

Honjol, Y., Monk, R., Schupbach, D., Merle, G., & Harvey, E. J. (2022). Porcine Model of Acute Compartment Syndrome. J Orthop Trauma. https://doi.org/10.1097/ bot.0000000000002505

A pre-clinical model mimicking human compartment syndrome was developed using vascular occlusion plus crush or direct muscle crush maintained for over 5 hours. Intramuscular pressure was monitored continuously. After two hours of observation at elevated pressures (balloon catheter: avg. 25.1 mmHg; ischemia-reperfusion + direct crush: avg. 33.7 mmHg), fasciotomy reduced pressures to physiological levels (balloon catheter: avg. 2.4 mmHg; crush: avg. 4.9 mmHg). This model reliably replicates human response to injury and treatment, enabling testing of compartment syndrome therapies.

Schupbach, D. E., Nasser Eddine, M., Honjol, Y., Merle, G., & Harvey, E. J. (2021). Percutaneous Forefoot Decompression in a Foot Compartment Syndrome Model. JBJS Open Access, 6(4), e21.00040. https://doi. org/10.2106/jbjs.Oa.21.00040

A cadaveric study demonstrated that a novel percutaneous decompression technique using two small dorsal incisions effectively and safely reduced pressures in foot compartments (from 43.8 mm Hg to 9.5 mm Hg, p < 0.05) without damaging critical structures. This less invasive and reproducible method offers a potential alternative to open fasciotomies, which have higher morbidity. The study validates the accuracy and utility of the MY01 continuous pressure monitoring system in improving compartment syndrome management and highlights the clinical relevance of MY01 technology for innovative treatment protocols.

Schupbach, D., Honjol, Y., Bouklouch, Y., Merle, G., & Harvey, E. J. (2022). Acute Compartment Syndrome Modeling with Sequential Infusion Shows the Deep Posterior Compartment Is Not Functionally Discrete. J Bone Joint Surg Am, 104(9), 813-820. https://doi.org/10.2106/ jbjs.21.00291

A cadaveric study using the MY01 sensor showed the deep posterior compartment doesn’t function independently in acute compartment syndrome. Its pressure changes mirrored adjacent posterior compartments, suggesting decompression of anterior and lateral compartments alone may be enough. This indicates standard acute compartment syndrome surgery could be improved by skipping deep posterior release, reducing risks. The study also confirms the MY01 sensor’s accuracy for continuous pressure monitoring, aiding in better acute compartment syndrome management.

Lorange, J.-P., Laverdière, C., Corban, J., Montreuil, J., & Harvey, E. J. (2023). Diagnosis Accuracy for Compartment Syndrome: A Systematic Review and Meta-Analysis. Journal of Orthopaedic Trauma, 37(8), e319-e325. https://doi.org/10.1097/ bot.0000000000002610

A meta-analysis of 7 studies (1,281 tibial fractures) evaluated ACS diagnosis using clinical findings and intracompartmental pressure (ICP) monitoring. ICP monitoring (90% sensitivity, 88% specificity) outperformed clinical findings alone (77% sensitivity, 86% specificity). Combining both increased diagnostic probability to 69%. The study emphasizes ICP monitoring’s crucial role alongside clinical evaluation to improve diagnostic accuracy. Standardized protocols and validation of new technologies are needed.

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Downloaded from https://academic.oup.com/milmed/article-abstract/185/Supplement_1/77/5734975 by guest on 20 February 2020

MILITARY MEDICINE, 185, S1:77, 2020
Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome
Geraldine Merle, PhD*; Marianne Comeau-Gauthier, MD*; Vahid Tayari, PhD; Mohamad Nizar Kezzo, BEng; Chrouk Kasem, BEng; Faisal Al-Kabraiti, BEng;
Carl Laverdiere, BEng*; George Xereas, PhD; Edward J. Harvey, MD, MSc*
ABSTRACT Introduction: Acute compartment syndrome (ACS) is a well-recognized and common emergency. Undiagnosed ACS leads to muscle necrosis, limb contracture, intractable pain, and may even result in amputation. Methods: Three devices (Synthes, Stryker, and MY01) were compared in a pre-clinical rat abdominal compartment syndrome simulation. Simultaneous measurements of intracompartmental pressures allowed concurrent comparison among all devices. Results: Large variations from the reference values are seen with the Synthes and Stryker devices. Variances are large in these two devices even under ideal conditions. The MY01 device was the truest indicator of reference pressure in this ACS model (over 600% more accurate). Conclusions: The MY01 device was the most accurate device in tracking pressure changes in this rat model of abdominal compartment syndrome.

INTRODUCTION Acute compartment syndrome (ACS) remains a clinical problem for all trauma victims. High-energy trauma causes swelling and increased pressure within the affected muscle compartments resulting in reduced blood flow. ACS is a well-recognized and common emergency.1 The usual cause of this condition is trauma. Undiagnosed ACS leads to muscle necrosis, contracture, and could eventually result in chronic infection or amputation. The only way to avoid these complications is early recognition and attendant decompression of the affected muscle with a large incision to release the fascial containment of the compartment.2 Missed compartment syndromes are an issue in combat situations.3 A failure to release the supra-physiological pressure within a few hours will result in muscle death and severe intractable pain, paralysis, or sensory deficits.4,5 A reliable method for the accurate and reproducible diagnosis of ACS, especially in the obtunded, polytrauma, or distracted patient, has yet to be developed. Currently, the diagnosis of ACS is made on the basis of physical exam and repeated needle sticks over a short timeframe to measure intracompartmental pressures. Existing technology for continuous pressure measurements is insensitive,6 particularly in the deep tissues
*McGill University Health Center Research Institute, Montreal General Hospital, 1650 Cedar Ave, Montreal, QC H3G1A4
Department of Surgery, McGill University, Montreal General Hospital, 1650 Cedar Ave, Montreal, QC H3G1A4
NXTSens Inc., 85 St Paul St West, Montreal, QC H2Y3V4 Presented as a poster at the 2018 Military Health System Research Symposium, August 2018, Kissimmee, FL; abstract no. MHSRS-14-0259 The views expressed in this paper are those of the authors and do not necessarily represent the official position or policy of the U.S. Government, the Department of Defense, or the Department of the Air Force. doi:10.1093/milmed/usz305 © Association of Military Surgeons of the United States 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

and compartments,7 and their use is restricted to highly trained personnel.8 They are of little use in field conditions. Consequently, resolution or clarification of the diagnosis of ACS would be a great asset. Although newer technologies are being tested,7,912 many newer techniques seem to have major diagnostic problems and/or interfere with complete care of the patient. There is therefore a need for an always-on minimally invasive device that does not interfere with transportation or total care of the patient. An insert and forget technique for continuous monitoring is also desirable. Newer technology needs to monitor all potential areas of interest without being labor-intensive, relying on highly educated technicians, or be excessively user dependent.
Over the past several years, tremendous advances in silicon microfabrication techniques have led to the development of miniaturized sensors (including but not limited to pressure, temperature, acceleration, flow, angular acceleration, touch) that are finding many applications in video gaming devices, automotive and aerospace industries, process control and industrial monitoring, and medical monitoring. A newer device based on this technology is being brought to the market that seems to have the potential of fulfilling these criteria. MY01 (NXTSens Inc., Montreal, Canada) is a temporary, indwelling compartment-based sensor that can be accurately inserted by technical personnel with minimal training via a single needle syringe. The authors represent an academiccorporate relationship with interests in the corporate entity in the form of ownership and future possible stock holdings. The device is currently undergoing FDA regulatory approval. The device is capable of single point measurements or continuous real-time monitoring. The goal of this project was to compare its performance against two currently used technologies (Stryker [Stryker Inc., Kalamazoo, MI, USA] and Synthes [Depuy-Synthes Inc., West Chester, PA, USA] compartment pressure measurement devices). Building on prior laboratory work, a preclinical pilot study was carried

ORIGINAL ARTICLE

Porcine Model of Acute Compartment Syndrome
Yazan Honjol, MD, MSc,a Rachel Monk, BSc,a Drew Schupbach, MD, MSc,a,b Geraldine Merle, PhD,b and Edward J. Harvey, MD, MScb

Objectives: Acute compartment syndrome is a devastating condition associated with lasting consequences or even death if not treated in a timely fashion. Current preclinical modeling is inadequate. Ideally a model should mimic human disease. There should be a trauma-induced reperfusion or direct muscle event that causes gradual increased pressure and is amenable to release with fasciotomy. We have attempted to reproduce this mechanism and outcome in a porcine model.
Methods: Anterior tibial musculature was injured with vascular occlusion plus exterior tourniquet crush or direct intracompartmental crush through balloon inflation. The injury was maintained for over 5 hours. At that time, the tourniquet or balloon was removed. The injuries were continuously monitored with an intramuscular continuous pressure sensor. Pressure changes were recorded and after 2 hours of postinjury observation, a fasciotomy was performed for the muscle compartment.
Results: Pressures were brought to 100 mm Hg during the injury phase. During the two-hour observation period, the balloon catheter technique achieved an average pressure of 25.1 6 SD 8.8 mm Hg with a maximum reading of 38.2 mm Hg and minimum reading of 14.1 mm Hg. During this same period, the ischemia-reperfusion + direct crush technique achieved an average pressure of 33.7 6 SD 7.3 mm Hg, with a maximum reading of 43.5 mm Hg and minimum reading of 23.5 mm Hg. Average pressure postfasciotomy for the balloon catheter technique was 2.4 6 SD 2.5 mm Hg; and for the crush technique, average value postfasciotomy was 4.9 6 SD 3.7 mm Hg–both representing a return to physiologic levels.
Conclusion: This is the first preclinical model that shows the same response to injury and treatment as is observed in human physiology.
Accepted for publication October 6, 2022. From the aMcGill University, School of Medicine, Experimental Surgery
Program; and bDepartment of Surgery, McGill University, McGill University Health Center Research Institute, Injury Repair Recovery Program, Montreal, Canada. Supported by the Office of the Assistant Secretary of Defense for Health Affairs through the FY18 Defense Medical Research and Development Program, endorsed by the Department of Defense, through the FY18, DMRDP JPC-6/CCCRP Precision Trauma Care Research Award under Award No. W81XWH1920010. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. The authors report no conflict of interest. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. Reprints: Edward J. Harvey, MD, MSc, Department of Surgery, McGill University, 1650 Cedar Avenue, Room B5.159.5, Montreal, Canada, H3G 1A4 (e-mail: edward.harvey@mcgill.ca). Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/BOT.0000000000002505
e122 | www.jorthotrauma.com

Surgical and nonsurgical therapies for compartment syndrome can now be tested reliably.
Key Words: porcine, model, compartment syndrome, preclinical, pressure, fasciotomy
(J Orthop Trauma 2023;37:e122e127)
INTRODUCTION
Acute compartment syndrome (ACS) is a surgical emergency most commonly occurring in the extremities because of trauma and resultant swelling within a closed osseofascial compartment. It is seen to ultimately be the result of increasing pressure leading to circulatory compromise, tissue ischemia, necrosis, and neuromuscular dysfunction.15 It can lead to devastating and lasting consequences if not treated adequately or in time.68 It is commonly understood that abnormally elevated pressure within a compartment is an early and important marker of ACS.2,9 Continuous pressure monitoring of the affected compartment is a desired marker for the progression or resolution of ACS, provides the basis for recommendations regarding the need for fasciotomy,2,9,10 and is supported by the evidence-based AAOS Clinical Practice Guideline for the Management of Acute Compartment Syndrome11.
The heterogeneous clinical course of ACS has made it difficult to investigate. Various cadaveric and animal models have been developed to help understand the complex and debilitating nature of this condition.1221 The most popular methods used by these papers for induction of a compartment syndrome include the use of tourniquets or intracompartmental infusion/balloon techniques directly into the compartment. Live animal models have proven useful in the investigation of pressure sensing techniques and histologic analysis of muscle damage after injury;18,22,23 however, care needs to be taken when analyzing results because certain anatomical and physiologic differences between models exist. Use of companion animals such as primates or canines has been observed to be less desirable. Modelling some aspects of diagnosis and treatment of ACS using a porcine hind limb has proven especially useful given their similar anatomy, size better suited for human instrumentation, and similar blood pressure–a physiological parameter vital in compartment syndrome.2,24,25 Xanthos et al26 studied baseline hemodynamics such as blood pressure in swine and found relatively similar values to those of humans, which is important when assessing perfusion pressure. Delta P or perfusion pressure values of relevance to pig physiology have yet to be determined. Methods of inducing ACS in these models have been through intracompartmental infusion/balloon techniques and tourniquet-induced
J Orthop Trauma Volume 37, Number 3, March 2023

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Percutaneous Forefoot Decompression in a Foot Compartment Syndrome Model
Drew E. Schupbach, MD*, Mohamad Nasser Eddine, MD*, Yazan Honjol, MD, Geraldine Merle, PhD, and Edward J. Harvey, MD Investigation performed at McGill University Health Centre Research Institute, Montreal, Quebec, Canada

Background: Acute compartment syndrome of the foot is a controversial topic. Release of the foot has been seen as complicated because of large incisions and postoperative morbidity, and there has been debate over whether this procedure is actually effective for releasing all areas of increased pressure. New sensor technology affords the opportunity to advance our understanding of acute compartment syndrome of the foot and its treatment. The purpose of the present study was to determine whether percutaneous decompression could be performed for the treatment of compartment syndrome in a forefoot model.
Methods: The present study utilized a validated continuous pressure sensor to model compartment syndrome in human cadaveric feet. We utilized a pressure-controlled saline solution infusion system to induce increased pressure. A novel percutaneous release of the forefoot was investigated to assess its efficacy in achieving decompression.
Results: For all cadaveric specimens, continuous pressure monitoring was accomplished with use of a continuous pressure sensor. There were 4 discrete compartment areas that could be reliably pressurized in all feet. The average baseline, pressurized, and post-release pressures (and standard deviations) were 4.5 ± 2.9, 43.8 ± 7.7, and 9.5 ± 3.6 mm Hg, respectively. Percutaneous decompression produced a significant decrease in pressure in all 4 compartments (p < 0.05).
Conclusions: With use of continuous compartment pressure monitoring, 4 consistent areas were established as discrete compartments in the foot. All 4 compartments were pressurized with a standard pump system. With use of 2 small dorsal incisions, all 4 compartments were successfully released, with no injuries identified in the cutaneous nerve branches, extensor tendons, or arteries. These results have strong implications for the future of modeling compartment syndrome as well as for guiding clinical studies.
Clinical Relevance: A reproducible and accurate method of continuous pressure monitoring of foot compartments after trauma is needed (1) to reliably identify patients who are likely to benefit from compartment release and (2) to help avoid missed or evolving cases of acute compartment syndrome. In addition, a reproducible method for percutaneous compartment release that minimizes collateral structural damage and the need for secondary surgical procedures is needed.

A cute compartment syndrome (ACS) is a condition in which elevated pressures within a fascial compartment in the body compromise its blood supply, leading to death of the contained tissues1-3. The estimated incidence of extremity ACS is 3.1 per 100,000 people/year (representing 1% to 9% of reported lower-extremity fractures), with a strong male predominance4-6. The incidence of isolated foot compartment syndrome is highest following crush mechanisms either with (18%) or without (14%) a forefoot fracture. Only 1% of patients with an isolated calcaneal fracture are treated for

ACS7. Currently, there is no reliable method to diagnose and treat foot compartment syndrome8,9. While seemingly a simple concept from a physics standpoint, the clinical presentation, diagnosis, and treatment of ACS present a more complex picture. The diagnosis of compartment syndrome is made primarily on the basis of clinical symptoms of ischemia, with pressure measurement being used as an adjunct. The treatment of ACS usually involves emergency release of the pressure through fasciotomy10. In the foot, the most common complications of ACS are persistent neurologic deficits, claw toes,

*Drew E. Schupbach, MD, and Mohamad Nasser Eddine, MD, contributed equally to this work.

Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJSOA/A349).

Copyright Ó 2021 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

JBJS Open Access d 2021:e21.00040. http://dx.doi.org/10.2106/JBJS.OA.21.00040

openaccess.jbjs.org

813 COPYRIGHT Ó 2022 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED

Acute Compartment Syndrome Modeling with Sequential Infusion Shows the Deep Posterior
Compartment Is Not Functionally Discrete
Drew Schupbach, MD, MSc, Yazan Honjol, MD, MSc, Yasser Bouklouch, MSc, Geraldine Merle, PhD, and Edward J. Harvey, MD, MSc
Investigation performed at McGill University Health Center Research Institute, McGill University, Montreal, Quebec, Canada

Background: Clinical case series have indicated that 1 or 2-compartment decompression of the anterior or lateral leg may be sufficient for release, but, currently, no cadaveric model has verified that approach. The objective of this study was to investigate the functional relationship between compartments by alternating sequences of infusion and fasciotomy release.
Methods: This study utilized multicompartment sequential pressurization with simultaneous monitoring by continuous pressure sensors to model compartment syndrome in a human cadaver leg. Subsequent sequential release of compartments and continuous streaming of pressure readings permitted unique insights.
Results: A leg model allowed the examination of pressure changes in all 4 compartments as treated with sequential fasciotomies. The successful modeling of lower-leg pressures consistent with compartment syndrome showed that discrepancies relative to accepted concepts were seen when the deep posterior compartment was pressurized in isolation. Also, release of 1 of the 2 of either the anterior or lateral compartments seems to be sufficient for decompression to acceptable pressure levels.
Conclusions: The deep posterior compartment does not appear to be completely discrete and instead follows the pressurization curve of the posterior muscle group. This indicates that release of the deep posterior compartment may not be needed in all acute compartment syndrome scenarios.
Clinical Relevance: Surgical techniques can be modified for treatment of acute compartment syndrome to avoid large scar lengths, deep dissection, and multiple exposures that could improve patient outcomes.

A cute compartment syndrome (ACS) most commonly occurs in the extremities as a result of trauma, including fracture or crushing injury, or other conditions resulting in intracompartmental swelling1. The incidence of extremity ACS is estimated at 3.1 per 100,000 people per year, with a strong predominance of young, male patients with trauma (a reported incidence of 1% to 9% in cases of lower-extremity fracture)2. In tibial diaphyseal fractures, the lower-leg ACS incidence has been reported in 2 retrospective, single-center cohorts as 8.1% (414 patients) and 11.5% (1,407 patients)3,4. Similar incidence has been reported in prospective studies5. ACS has been seen as a simple diagnostic concept in which higher pressures in a muscle lead to muscle death from compromised blood flow. Its clinical presentation, diagnosis, and treatment present a more complex picture.

The diagnosis of compartment syndrome has been primarily through clinical symptoms, with direct pressure measurement used only as an adjunct because of its inaccuracy. The treatment of ACS involves the release of the pressure through fasciotomy6-11. For lower-limb fasciotomy, the standard technique involves the release of all 4 anatomic compartments: anterior, lateral, posterior, and deep posterior (Fig. 1) . 7,12-15 If not released within a few hours, ACS can progress to the patient experiencing tissue death resulting in paralysis, loss of limb, or even death16-18. Early research has suggested that a compartment was at risk with an absolute pressure as low as 30 mm Hg19-21. New technological advances in pressure sensors have provided us with the opportunity to better study and manage this condition. The use of continuous pressure monitoring, as recommended by the American Academy of

Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/G881).
Disclaimer: Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

MY01 Value Analysis | Clinical and Preclinical Evidence

35.1 35.1

Paper

Description

Bouklouch, Y., Bernstein, M., Bosse, M., Cota, A., Duckworth, A. D., Dunbar, R. P., Gamulin, A., Guy, P., Hak, D. J., Haller, J. M., Hayda, R., Jarragh, A., Johnstone, A. J., Karunakar, M., Lawendy, A. R., Leighton, R., Mavrogenis, A. F., Mauffrey, C., Miclau, T., . . . Harvey, E. J. (2023). Postfasciotomy Classification System for Acute Compartment Syndrome of the Leg. J Orthop Trauma, 37(11), 581-585. https:// doi.org/10.1097/bot.0000000000002663

A new five-grade classification system for acute compartment syndrome severity post-fasciotomy was developed and validated by international experts using a modified Delphi method. The system, ranging from prophylactic fasciotomy (Grade 1) to amputation (Grade 5), showed strong inter-rater reliability (Fleiss’ Kappa = 0.711) and high internal consistency (median Kendall coefficient = 0.855) in clinical scenario testing. This framework standardizes acute compartment syndrome severity evaluation, aiding prognostication, treatment, economic analysis, communication, and research by providing clear benchmarks for outcomes and costs. The classification improves acute compartment syndrome understanding and management, benefiting patient outcomes and healthcare burden assessment.

Bouklouch, Y., Schmidt, A. H., Obremskey, W. T., Bernstein, M., Gamburg, N., & Harvey, E. J. (2022). Big data insights into predictors of acute compartment syndrome. Injury, 53(7), 2557-2561. https:// doi.org/10.1016/j.injury.2022.02.041

A study of 203,500 tibial fractures identified key acute compartment syndrome predictors and outcomes. Proximal and midshaft fractures significantly increased acute compartment syndrome risk, with open fractures doubling the likelihood. Other risk factors included male sex, younger age, smoking, substance use, and cirrhosis. Muscle necrosis occurred in 16.9% of fasciotomies and was linked to complex fractures and comorbidities. The fasciotomy rate was 4.3%, varying by trauma center level. The study highlights the importance of soft tissue damage and fracture complexity in acute compartment syndrome, revealing new links to systemic conditions like cirrhosis and hypertension. This big-data analysis offers crucial insights for acute compartment syndrome risk assessment and clinical decision-making in trauma care.

JID: JINJ

ARTICLE IN PRESS
Injury xxx (xxxx) xxx Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury

[m5G;March 3, 2022;13:25]

Big data insights into predictors of acute compartment syndrome
Yasser Bouklouch a, Andrew H Schmidt b, William T Obremskey c, Mitchell Bernstein a,d, Nicole Gamburg a, Edward J Harvey a,d,
a McGill University Health Center – Research Institute b Hennepin County Hospital, Department of Orthopaedic Surgery c Department of Orthopaedic Surgery Vanderbilt Medical Center, Vanderbilt Center for Musculoskeletal Research d McGill University Department of Surgery, Division of Orthopaedic Surgery

article info
Article history: Accepted 16 February 2022 Available online xxx
Keywords: Acute compartment syndrome Big data Complications Trauma

a b s t r a c t
Background: There remain gaps in knowledge regarding the pathophysiology, initial diagnosis, treatment, and outcome of acute compartment syndrome (ACS). Most reported clinical outcomes are from smaller studies of heterogeneous patients. For a disease associated with a financial burden to society that represents billions of dollars worldwide the literature does not currently establish baseline diagnostic parameters and risk factors that may serve to predict treatment and outcomes. Methods: This study looks at a very large cohort of trauma patients obtained from four recent years of the Trauma Quality Programs data from the American College of Surgeons. From 3,924,127 trauma cases – 203,500 patients with tibial fractures were identified and their records examined for demographic information, potential risk factors for compartment syndrome, an associated coded diagnosis of muscle necrosis, and presence of other outcomes associated with compartment syndrome. A recurrent multiple logistic regression model was used to identify factors predictive of fasciotomy. The results were compared to the reported results from the literature to validate the findings. Results: The rate of fasciotomy treatment for ACS was 4.3% in the cohort of identified patients. The analysis identified several clinical predictors of fasciotomy. Proximal and midshaft tibial fractures (P <0.0001) showed highest increases in the likelihood of ACS. Open fractures were twice (O.R [2.202.42]) as likely to have ACS. Having a complex fracture (P<0.0001), substance abuse disorder (P<0.0002), cirrhosis (P = 0.002) or smoking (P<0.0051) all increased the likelihood of ACS. Age decreased the likelihood by 1% per year (OR= [0.990.993]). Crush and penetrating injuries showed an important increase in the likelihood of ACS (O.R of 1.83 and 1.37 respectively). Additionally, sex, BMI, cirrhosis, tobacco smoking and fracture pattern as defined by OTA group and OTA subgroup had predictive value on actual myonecrosis. Fasciotomies for open tibial fractures were more likely to uncover significant muscle necrosis compared to closed fractures. Amputation resulted after 5.4% of fasciotomies. Conclusion: This big data approach shows us that ACS is primarily linked to the extent of soft tissue damage. However, newfound effect of some comorbidities like cirrhosis and hypertension on the risk of ACS imply other mechanisms.
© 2022 Elsevier Ltd. All rights reserved.

This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the FY18 Defense Medical Research and Development Program, endorsed by the Department of Defense, through the FY18, DMRDP JPC-6/CCCRP Precision Trauma Care Research Award under Award No. W81XWH1920010. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense
Corresponding author at: Montreal General Hospital, 1650 Cedar Ave Room B5.159.5, Montreal, Quebec H3G1A4, Canada.
E-mail address: Edward.harvey@mcgill.ca (E.J. Harvey).

Introduction
Acute Compartment Syndrome (ACS) is a condition where elevated pressure within a myofascial compartment compromises its blood supply possibly leading to death of the contained tissues [1 3]. If not diagnosed and treated promptly, ACS results in patient morbidity, increased amputation risk, and increased costs of care. Long bone fractures have the highest likelihood of ACS complication [35]. Risk factors for the development of ACS have been proposed [4,6]. ACS is thought to be strongly associated with young age and to be more likely in male trauma victims but the reasons for this have not been clearly defined. McQueen et al. [7] hypothe-

Published and Ongoing Data
MY01 is currently supporting 5 ongoing multisite post-market clinical studies, which will combine for over 400 patients. These studies are being overseen by the 11-member Compartment Syndrome Research Collaboration Steering Committee (Steering Committee). The Steering Committee consists of members of the Major Extremity Trauma and Rehabilitation Consortium (METRC) along with members of ongoing MY01-affiliated research.
The steering committee is intended to ensure the continuity of compartment syndrome study research goals, streamlining the sharing of data, and effectively allocating inter-organizational resources. Augmented by historic data accumulated during past METRC projects, committee members will also have access to a common database of cases to drive important insights in the management of Compartment Syndrome.

MY01 Value Analysis | Clinical and Preclinical Evidence

35.1 35.1

Paper

Description

Use of Novel Digital Continuous Pressure Sensor for Diagnosis Compartment Syndrome

The MY01 cICP device aided ACS diagnosis and management in three cases. In one case, early fasciotomy guided by cICP in a patient without typical symptoms prevented necrosis. In another, overnight cICP monitoring prompted timely decompression, preventing damage. In a third, stable cICP readings avoided unnecessary surgery. Continuous pressure data from MY01 enabled early ACS detection in two cases and ruled it out in another, improving management by supporting timely intervention and avoiding unnecessary procedures and complications. This highlights its potential in trauma centers and remote locations.

Nasser Eddine, M., Schupbach, D. E., Honjol, Y., Merle, G., & Harvey, E. J. (2022). Minimal Percutaneous Release for Acute Compartment Syndrome of the Foot: A Case Report.
JBJS Case Connect, 12(3). https:// doi.org/10.2106/jbjs.Cc.21.00484

A 34-year-old male with a pilon fracture and acute compartment syndrome (ACS) of the forefoot was successfully treated with a novel minimally invasive percutaneous decompression using two 1-cm dorsal incisions. Compartment pressures were reduced from over 50 mm Hg to normal (512 mm Hg), resulting in immediate pain relief and full functional recovery without complications at 6 weeks, 6 months, and 1 year. This case demonstrates the effectiveness of a percutaneous approach for ACS of the foot, avoiding the morbidity of open fasciotomies and supporting broader use of minimally invasive techniques.

Schupbach, D., Reindl, R., Gill, H. L., Liberman, A. S., & Harvey, E. J. (2024). Continuous Compartment Pressure Monitoring Allows the Early Detection of Compartment Syndrome After Arterial Revascularization. Cureus, 16(3), e55451. https:// doi.org/10.7759/cureus.55451

A 28-year-old male undergoing pelvic exenteration developed an avascular right leg due to an iliac artery injury. Continuous intracompartmental pressure (ICP) monitoring, initiated despite absent clinical compartment syndrome (CS) signs, revealed a pressure rise necessitating surgical fasciotomy. Intraoperative findings confirmed Grade 2 CS with reversible muscle damage. The wounds were closed within 72 hours. This case highlights the value of continuous MEMS-based ICP monitoring for early CS detection in complex cases, improving diagnostic accuracy, treatment timing, and resource use.

Frane, N., Doxey, S. A., Huyke-Hernández, F. A., Cunningham, B. P., & McKee, M. D. (2024). Use of a Continuous Intracompartmental Pressure Monitoring Device During Fasciotomy. Orthopedics, 47(2), e98-e101. https://doi. org/10.3928/01477447-2023102703

A 52-year-old male with a bicondylar tibial plateau fracture and acute compartment syndrome underwent fasciotomy with continuous intracompartmental pressure monitoring using the MY01 device. Pressures decreased from a high of 105 mm Hg to 10 mm Hg after full release of all compartments. Postoperatively, the patient had restored sensation, no complications, full recovery at one year, and fracture union. This case highlights the value of real-time cICP monitoring during fasciotomy with the MY01 device to confirm adequate compartment release and potentially improve outcomes in ACS management. Future research could investigate postoperative use.

Haidar, A., Pauyo, T., Harvey, E., & Drager, J. (2024). Resolution of Confusion Over Compartment Syndrome After Tibial Osteotomy With Con-
tinuous Pressure Measurements. Cureus, 16(5), e61114. https://doi. org/10.7759/cureus.61114

A 13-year-old female with autism and severe leg pain after a tibial tubercle osteotomy presented a challenging clinical assessment for compartment syndrome (CS). Continuous intracompartmental pressure (cICP) monitoring using the MY01 device showed decreasing pressures without critical elevations, ruling out CS and avoiding a fasciotomy. Optimized pain management with a nerve block resolved symptoms, leading to a smooth recovery. This case highlights the value of cICP monitoring in complex presentations where CS diagnosis is difficult, enabling objective data for clinical decisions, preventing unnecessary surgery, and improving patient outcomes.

Al Nasser, A. M., Harvey, E. J., & Bunting, A. C. (2024). Early Detection of Compartment Syndrome With Minimal Symptoms: A Case Report on Continuous Pressure Monitoring. Cureus, 16(11), e74453. https://doi. org/10.7759/cureus.74453

A 53-year-old woman with a tibial fracture and minimal symptoms showed increasing intracompartmental pressure (cICP) (55-70 mmHg, delta P 10 mmHg) via MY01 monitoring. Despite no clear clinical signs of compartment syndrome (CS), early fasciotomy, guided by cICP trends, revealed and resolved early CS, leading to full recovery. This case highlights the importance of cICP monitoring for early CS diagnosis and intervention when clinical signs are unclear, preventing muscle damage and morbidity.

MY01 Value Analysis | Clinical and Preclinical Evidence

Case Report

OPEN

Novel digital continuous sensor for monitoring of compartment pressure: a case report
Julien Montreuil, MD, MSc, Jason Corban, MD, Rudolf Reindl, MD, Edward J. Harvey, MD, MSc, Mitchell Bernstein, MD

Abstract Case: The American Academy of Orthopaedic Surgeons has recently identified continuous intracompartmental pressure monitoring as 1 of the few means to assist in ruling out acute compartment syndrome (ACS). There are very few methods that allow this measurement. This manuscript describes the use of a new digital monitoring system for ACS in 3 patients. This minimally invasive device, the MY01 (NXTSENS, Montreal, Canada) is capable of continuously and precisely measuring variations in intracompartmental pressure.
Conclusion: MY01 detected the occurrence of ACS at early-stage and expedited the timing of surgery for 2 patients. This tool also objectively excluded a suspected diagnosis of ACS in a medically comorbid patient, obviating the need for unnecessary fasciotomies and potential complications.
Keywords: acute compartment syndrome, continuous intracompartmental pressure, fasciotomy, pressure monitoring

1. Introduction
Acute compartment syndrome (ACS) is a limb-threatening condition and a true surgical emergency. It is characterized by increased intracompartmental pressure (ICP) compromising the microcirculation of the muscle.[1,2] Tissue ischemia develops within a noncompliant myofascial compartment, which may subsequently lead to irreversible myonecrosis within hours from symptom onset.[3,4] While the most common etiology is trauma, other less common etiologies such as burns, emboli, and iatrogenic injuries can be equally troublesome and make diagnosis challenging.[5] Ischemic neuropathy, contractures, chronic infection or amputation are possible with devastating long-term complications.[1,6] Therefore, compartment syndrome requires an early clinical recognition and accurate diagnosis, followed by an emergency decompressive fasciotomy.[6] Early clinical findings often include pain out of proportion to injury, pain with passive stretch, and tenseness
EJH: Founder of the company NXTSens. Grant payment by Department of Defense and paid to the institution. MY01 Inc compensation to author. Son works as intern at MY01 inc.
MB: Grant payment by NXTSens and paid to the institution.
The authors have no conflicts of interest to disclose.
Montreal General Hospital, McGill University Health Center, Montreal, Quebec, Canada. Corresponding author. Address: McGill University Division of Orthopaedic Surgery, Division of Orthopaedics, Montreal General Hospital, 1650 Cedar Ave, Montreal, Quebec, H3G 1A4, Canada. E-mail address: julien.montreuil@mail.mcgill.ca (J. Montreuil).
Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Orthopaedic Trauma Association. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NCND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
OTA (2022) e208
Received: 21 October 2021 / Accepted: 20 March 2022
Published online 29 June 2022
http://dx.doi.org/10.1097/OI9.0000000000000208

of the involved compartment.[1,6] Neurological symptoms, pallor, and pulselessness are considered late findings.[1,6] Currently, ACS is diagnosed based on physical examination or single point of time ICP measurement when evaluating unconscious patients.[79] In order to improve diagnostic accuracy and precision, a minimally invasive tool that is capable of continuous intracompartmental pressure (cICP) monitoring has been advocated by the American Academy of Orthopaedic Surgeons.[10] This case report highlights the use of a device that employs cICP to help the clinician accurately diagnose ACS.
MY01 (MY01 Inc., Montreal, Canada) is an indwelling sensor that can be inserted in a muscle compartment. It is a single use disposable device that stays in up to 18 hours and gives results on a display tethered to the compartment in question. It also can feed directly to the care provider through a cellphone application (Fig. 1). With its novel microelectromechanical sensors, MY01 has been shown to have superior ICP measurements accuracy over other existing devices.[11] The MY01 device can be used to capture several single-point measurements from up to 5 different insertion sites. Clinical judgement is paramount to decision in which compartment the pressure is trended. It is meant to act as an aid to clinicians in monitoring ACS. The burden of a missed ACS is immense for both the patient and health care system. Although timely fasciotomy is generally well tolerated and inexpensive relative to other surgical procedures, unnecessary fasciotomies are not innocuous. The ability to more accurately diagnose ACS benefits patients by simultaneously avoiding missed compartment syndromes and avoiding unnecessary fasciotomies.[12] This manuscript underlines the novel use of this digital continuous pressure monitoring sensor for the diagnosis of compartment syndrome. This device is approved by the Food and Drug Administration and Health Canada. All monitored data is encrypted and associated with a Health Insurance Portability and Accountability Act compliant database in the context of a prospective study approved by local ethics board. Each patient was informed that data concerning their case could be submitted for publication, and informed consent was provided.

1 COPYRIGHT Ó 2022 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED

Minimal Percutaneous Release for Acute Compartment Syndrome of the Foot
A Case Report
Mohamad Nasser Eddine, MD, Drew E. Schupbach, MD, MSc, Yazan Honjol, MD, MSc, Geraldine Merle, PhD, and Edward J. Harvey, MD, MSc
Investigation performed at the McGill University Health Center, Montreal, Quebec, Canada
Abstract Case: A 34-year-old man had an injury which resulted in pilon fracture and acute compartment syndrome of his forefoot. The case report describes the use of a novel minimally invasive dorsal approach for decompression of the lateral, central, medial, and interosseous compartments. The release was performed through multiple small incisions on the dorsal foot. The patient had complete relief with normal function of all muscle groups at 6 weeks and is now 18 months after surgery. He has returned to full activity. Conclusion: The successful decompression of the forefoot compartments through a percutaneous approach avoided known complications of muscle death, toe clawing, and secondary surgeries.

Immediate treatment of acute compartment syndrome (ACS) of the foot, perhaps even more than compartment syndrome in other locations, is associated with high morbidity. ACS of the foot is an unsolved problem. Surgeons have been hesitant to treat with acute surgical fasciotomy and instead opt for late reconstruction1. The true incidence of foot ACS is unclear although reported at 2% among foot injuries in the National Trauma Database2 from the American College of Surgeons. Many cases are reported as crush injuries to the foot with no surgical interventions for soft tissues. Even the number of compartments in the foot has not obtained 100% agreement3. It is generally accepted that there is a lateral compartment, a superficial central compartment, a medial compartment (sometimes described as 2 compartments with a separate abductor), and an interosseous compartment (described as either 1 continuous compartment or 4 separate compartments)3-5. Work by the current authors6 has shown that 4 compartments consistently exist in the medial and volar forefoot, with a fifth possible compartment being the more superficial lateral abductor minimi group. This has been validated on a series of cadaver ACS models using

ultrasound, sequential compartment pressurization, and the use of multiple pressure monitors6,7 to determine the presence of physiological compartments. Traditionally, wide surgical releases have been used to accomplish compartment release. Open fasciotomy, however, has poor outcomes in the literature8. Alternatives to complete surgical fasciotomy for forefoot compartment syndrome were discussed by Myerson where they compared a dorsal approach versus a medial approach and showed that both achieved decompression5. The medial approach has been associated with more technical difficulty and an increased potential for neurovascular injury but has been seen as necessary for complete decompression. The dorsal approach does provide simultaneous exposure of osseous structures which may be in need of repair3. Even in dorsal approaches, the infection rate has been shown to be as high as 20% with an average of 3 additional procedures to close the wound9. To avoid the morbidity of traditional large incision fasciotomy, this case report describes a novel minimally invasive dorsal approach for decompression of the lateral, central, medial, and interosseous compartments (Fig. 1).

Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014, is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the FY18 Defense Medical Research and Development Program, endorsed by the Department of Defense, through the FY18, DMRDP JPC-6/CCCRP Precision Trauma Care Research Award under Award No. W81XWH1920010.
Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJSCC/B919). Keywords acute compartment syndrome; foot; minimally invasive; cadaver; surgery; case report; male and female: adult; necrosis

JBJS Case Connect 2022;12:e21.00484 d http://dx.doi.org/10.2106/JBJS.CC.21.00484

Open Access Case Report

DOI: 10.7759/cureus.55451

Review began 01/30/2024 Review ended 02/18/2024 Published 03/03/2024
© Copyright 2024 Schupbach et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CCBY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Continuous Compartment Pressure Monitoring Allows the Early Detection of Compartment Syndrome After Arterial Revascularization
Drew Schupbach 1, Rudy Reindl 1, Heather L. Gill 1, A S. Liberman 1, Edward J. Harvey 1
1. Surgery, McGill University, Montreal, CAN
Corresponding author: Edward J. Harvey, edward.harvey@mcgill.ca
Abstract Compartment syndrome (CS) occurs in several clinical scenarios. Reperfusion injury and tissue swelling are common causes. This can occur after trauma but also is seen post revascularization of extremities. CS is a difficult diagnosis to make in a timely fashion that avoids permanent tissue damage. The treatment for CS is immediate fasciotomy, but fasciotomy is not a complication-free procedure. Previous care pathways usually resulted in fasciotomy being performed in a disproportionate number of normal legs. These false positives and prophylactic releases are costly to the health system because of protracted hospital stays and increased surgery numbers. The desirable tool for surgeons would be one that decreases false positives and negatives while ensuring a diagnosis in a timely fashion with true positives. A new technology that allows continuous pressure monitoring seems to be the best aid to make a diagnosis. We present our experience in decreasing the time to diagnosis in a CS case post revascularization despite the neurological blockade.

Categories: Cardiac/Thoracic/Vascular Surgery, Pain Management, Trauma Keywords: pain, sensors, compartment syndrome, trauma, vascular, surgery
Introduction Compartment syndrome (CS) is a limb-threatening condition. The diagnosis of acute CS still currently is thought to be clinical. It relies on clinical findings, and the findings are debated. The 6Ps of increasing pain, paresthesia, pallor, pulselessness, paralysis, and poikilothermia are in many references. Later thinking includes pain out of proportion to the injury, pain on the passive stretch of the muscles in the affected compartment, hypoaesthesia (and later anaesthesia), and weakness in the distribution of the nerves traversing the compartment, swelling, and tight compartments. Unfortunately, any clinical findings are subjective. Pressure measurement has been used to aid in the diagnosis by some investigators but with mixed results. Early methods and devices used for measuring intracompartmental pressure (ICP) have limited accuracy and reliability [1,2]. Monitoring continuous pressure has been shown to decrease the time to surgery and aids in the diagnosis [3]. Gold standard treatment of acute CS consists of an emergency fasciotomy aiming to immediately reduce the pressure within the compartment [4]. The surgical wound is often left open for several days, and the necessity for delayed closure of the wound carries a high risk of infection and delayed healing or potentially delayed healing and potential nonunion. These risks are not limited to therapeutic fasciotomies; in fact, prophylactic fasciotomies have shown similar or higher risks of complication [4-6]. Additionally, big data analyses have shown that almost one in six fasciotomies revealed some degree of myonecrosis, and 5.4% of fasciotomies led to amputations [7]. This indicates that current techniques used for the diagnosis of ACS may be inadequate, resulting in late treatment or unnecessary interventions. The use of a new micro-electrical machine systems (MEMS)-based pressure monitor [2] has shown good results in trauma patients [8].
Case Presentation A 28-year-old male underwent pelvic exenteration surgery for a locally advanced stage of rectal cancer. He had a resection of rectal cancer 18 months previously. He had received neoadjuvant chemoradiotherapy at that time. He later underwent a planned ileostomy takedown and right lateral pelvic node dissection (LPND) six months thereafter. Unfortunately, he developed a significant local recurrence of his disease. He was offered radical local resection and was taken to the operating room for exenteration. This survey included resection of the colonic conduit and the previous anastomosis, as well as the right pelvic sidewall, seminal vesicle, and distal ureter. The surgery was complicated intraoperatively by an external Iliac artery injury. The injury was to the right external iliac artery and involved over 50% of the circumference. It was repaired with interposition of the internal iliac artery, which had previously been ligated as part of the exenteration, in order to avoid synthetic material in an infected field. Just over 3 cm of length was replaced, and a distal embolectomy was performed by the vascular surgery team. The complete duration of the exenteration and vascular surgery was 11 hours, performed in the Lloyd Davies position. This resulted in an avascular period of the right leg of at least four hours. The estimated blood loss for the surgery was 3 L. Resuscitation included five units of packed cells, two units of albumin and fresh frozen plasma, and 6,500 ML of crystalloid. The patient was taken to the post-anaesthesia care unit. An epidural was in place, which
How to cite this article n Case Report Schupbach D, Reindl R, Gill H L, et al. (March 03, 2024) Continuous Compartment Pressure Monitoring Allows the Early Detection of Compartment Syndrome After Arterial Revascularization. Cureus 16(3): e55451. DOI 10.7759/cureus.55451

Use of a Continuous Intracompartmental Pressure Monitoring Device During Fasciotomy
Nicholas Frane, DO; Stephen A. Doxey, DO; Fernando A. Huyke-Hernández, BS; Brian P. Cunningham, MD; Michael D. McKee, MD

abstract

A 52-year-old man presented with a bicondylar tibial plateau fracture and acute compartment syndrome. Continuous compartment pressure monitoring was used while the patient was treated with fasciotomies and application of an external fixator. The intraoperative pressure reading in the anterior compartment decreased from 105 mm Hg to 50 mm Hg after skin and subcutaneous tissue incision. Pressure continued to decrease to 10 mm Hg after all 4 compartments were released. The patient underwent staged open reduction and internal fixation and healed both fracture and fasciotomy incisions without complication. To our knowledge, this is the first report of continuous pressure changes during the different stages of a compartment release. Future studies could expand on use of this technology to gain information on compartment pressures during release and how single release affects pressures in other compartments. [Orthopedics. 202x;4x(x):xx-xx.]

Acute compartment syndrome (ACS) is an orthopedic emergency that typically follows trauma to an extremity.1,2 It is caused by an increase in myofascial intracompartmental pressure (ICP) leading to a local compromise in circulation.3 Although ACS has a low incidence of 3.1 per 100,000 individuals per year, a delayed or missed diagnosis can lead to amputation, organ failure, and death.2,4,5 Diagnosis is primarily made through physical examination and can be aided by compartment pressure measurement.6 Compartment pressure monitoring

is both sensitive and specific for ACS.7 A novel tool for continuous pressure monitoring is the MY01 (MY01 Inc). This single-use disposable monitoring sensor is inserted into a muscle compartment and can provide feedback for up to 18 hours. The device is approved for 5 individual measurements (1 in each compartment and then another to leave the device in the most at-risk compartment). This report describes the intraoperative use of the MY01 device in a patient with ACS in the setting of a bicondylar tibial plateau fracture.

Case Report A 52-year-old man presented to the
emergency department after a fall onto scaffolding 6 hours earlier. He sustained a left bicondylar tibial plateau fracture (AO/OTA 41-C3) (Figure 1A). Physical examination findings included a cool foot, a weak dorsalis pedis pulse, pain with passive motion of this great toe and ankle, and a tense anterior compartment. Additionally, the patient had paresthesia in the deep peroneal nerve distribution. A
The authors are from the Department of Orthopaedic Surgery (NF, MDM), University of Arizona College of Medicine, Phoenix, and the Department of Orthopaedic Surgery (NF, MDM), Banner University Medical Center, Phoenix, Arizona; and the Department of Orthopaedic Surgery (SAD, FAH-H, BPC), Park Nicollet Methodist Hospital, St. Louis Park, and the Department of Orthopaedic Surgery (SAD, FAH-H, BPC), TRIA Orthopaedic Institute, Bloomington, Minnesota.
Dr Frane, Dr Doxey, and Mr Huyke-Hernández have no relevant financial relationships to disclose. Dr Cunningham’s spouse is the founder and CEO of CODE Technology. Dr McKee is a paid consultant for Acumed, Bioventus, Exactech, ITS, MY01 Inc, and Stryker.
Correspondence should be addressed to: Brian P. Cunningham, MD, 6500 Excelsior Blvd, St. Louis Park, MN 55426 (brian.cunningham@ parknicollet.com).
Received: March 24, 2023; Accepted: September 25, 2023; Posted online: November 1, 2023.
doi: 10.3928/01477447-20231027-03

MONTH/MONTH 202x | Volume 4x · Number X

Open Access Case Report

DOI: 10.7759/cureus.61114

Review began 05/05/2024 Review ended 05/12/2024 Published 05/26/2024
© Copyright 2024 Haidar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Resolution of Confusion Over Compartment Syndrome After Tibial Osteotomy With Continuous Pressure Measurements
Abdullah Haidar 1, Thierry Pauyo 1, Edward Harvey 1, Justin Drager 1
1. Orthopedic Surgery, McGill University, Montreal, CAN
Corresponding author: Edward Harvey, edward.harvey@mcgill.ca
Abstract Compartment syndrome (CS) can occur in a variety of clinical scenarios. Reperfusion injury and tissue swelling are common causes across etiologies. Trauma is recognized as a common cause, but CS is also seen after limb alignment correction for extremities. CS is a difficult diagnosis to make in any scenario. Timely diagnosis is also difficult. Correct diagnosis is inexact, with many false positives and some false negatives being the normal outcome. This case represents a scenario where it was inherently difficult to make the diagnosis. The patient was a young patient with an underlying neurodevelopmental disorder where physical and clinical examination was impossible to accomplish. Any intervention to decrease pain was also difficult and actively refused by the patient and the family. Leaving open wounds after a fasciotomy was also undesirable for wound care and infection. Previous care maps have high false-positive rates or a need for fasciotomy as the treatment arm when diagnosis is uncertain. This usually results in fasciotomy being performed in many legs without CS. These false positives and resultant prophylactic releases are costly because of protracted hospital stay, high rate of deep infection, and decreased operating room availability for other cases. The desirable tool for surgeons would be the one that decreased false positives and false negatives while ensuring diagnosis in a timely fashion for true-positive cases. Technology for monitoring continuous pressure has been shown to aid in diagnosis. In this report, we illustrate the use of a continuous pressure monitoring system in a case of a pediatric patient post-osteotomy of a lower limb presenting with unremitting pain and a difficult clinical examination.

Categories: Emergency Medicine, Healthcare Technology, Trauma Keywords: technology, emergency, sensors, compartment syndrome, trauma, osteotomy, surgery
Introduction
Compartment syndrome (CS) continues to be a limb-threatening complication. The diagnosis of CS still relies on clinical findings of increasing pain, paresthesia, pallor, pulselessness, paralysis, and poikilothermia (also called “the 6P’s”). Arguably, the 6Ps are not good indicators for CS and many may be more appropriate for vascular injury, but they continue to be the clinical benchmark. The 6Ps are not objective diagnostic markers, relying on subjective evaluations that may or may not be reproducible between surgeons and other centers. This case illustrates a scenario where it is almost impossible to rely on clinical signs to provide a diagnosis. The patient presented 36 hours after a tibial tubercle osteotomy with severe pain and an inability to tolerate any physical examination or attempts to enhance the presenting diagnosis. Pressure has been used to aid in diagnosis, but, in the literature, there has been difficulty with objective values that have illustrated lessened reliability on single stick pressure measurement [1]. Early methods and devices used for measuring intracompartmental muscle pressure are well known to have limited accuracy and reliability [13]. Fortunately, the rate of CS in tibial osteotomy or leg realignment surgery is reported to be rare [4]. This does not take away the morbidity and risk associated with CS. Monitoring continuous pressure is accurate, decreases time to surgery, and aids in diagnosis [5-7], especially with the new more reliable methods for measurement. The standard treatment of CS still consists of an emergency fasciotomy that immediately reduces the pressure within the affected compartment. It has been shown that the number of fasciotomies vastly outnumbers the incidence of CS in the United States [8]. This would indicate that the current techniques used for the diagnosis or treatment of CS are insufficient and therefore result in unnecessary surgeries. There are attendant complications with all open wounds, and this is no different for fasciotomies. The fasciotomy wound is often left open for several days, which carries a high risk of infection and nonunion. In the case of this young patient, the surgeons did not feel that patient care would be optimized if fasciotomies were performed and that wound care would be very difficult. Use of MEMS (micro-electrical machine systems) based pressure monitoring has shown excellent results for extremity injuries [6]. This type of device was implemented as a diagnostic aid in this case to allow diagnosis.
Case Presentation
A 13-year-old near skeletally mature female presented with a history of recurrent patellar dislocation. Her past medical history included autism spectrum disorder, anxiety, and obsessive-compulsive disorder. She failed non-surgical treatment, and after a thorough discussion of the pros and cons of surgical management,

How to cite this artiOclpeen Access Case Report Haidar A, Pauyo T, Harvey E, et al. (May 26, 2024) Resolution of Confusion Over Compartment Syndrome After Tibial Osteotomy With Continuous Pressure Measurements. Cureus 16(5): e61114. DOI 10.7759/cureus.61114
Early Detection of Compartment Syndrome With

Minimal Symptoms: A Case Report on

Review began 11/14/2024 Review ended 11/21/2024 Published 11/25/2024

Continuous Pressure Monitoring Abdulrhman M. Al Nasser 1, Edward J. Harvey 1, Alexandra C. Bunting 1

© Copyright 2024 Al Nasser et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CCBY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
DOI: 10.7759/cureus.74453

1. Surgery, McGill University, Montreal, CAN
Corresponding author: Edward J. Harvey, edward.harvey@mcgill.ca
Abstract Compartment syndrome (CS) arises from various etiologies but is most commonly associated with severe traumatic injuries. It is a difficult diagnosis to make in a timely fashion because clinical signs and symptoms are subjective. Missing the diagnosis is a devastating mistake for the patient and the physician. There has been protracted debate over the effectiveness of clinical signs and symptoms, particularly concerns over their sensitivity and specificity. Both missed diagnoses and unneeded prophylactic releases are costly to the health system. A desired device would be an objective tool that decreased false positives and negatives while ensuring diagnosis in a timely fashion of true positives. The treatment for CS is immediate fasciotomy, but fasciotomy is not a complication-free procedure. Physicians need to be sure of the diagnosis both in order not to have the devastating consequence of a missed case but also not to perform with prophylactic fasciotomies that add to patient complications and the cost of treatment. Previous care maps usually resulted in fasciotomy being performed in extremities that will not or have not yet developed CS. New technology that allows monitoring of continuous pressure monitoring seems to currently be the best aid to diagnosis. We present our experience in using continuous pressure monitoring in decreasing time to diagnosis in a case post-trauma of a lower limb with minimal pain.

Categories: Trauma, Orthopedics, Healthcare Technology Keywords: compartment syndrome, pressure, sensors, surgery, trauma
Introduction Compartment syndrome (CS) is a limb-threatening condition. The diagnosis of CS, as classically taught, still currently relies on clinical findings of increasing pain, paresthesia, and paralysis. Unfortunately, the clinical signs are subjective. Pressure has been used to aid in diagnosis by some investigators with mixed results. Early methods used for measuring intracompartmental pressure (ICP) had limited accuracy [1,2]. Missed diagnoses result in large muscle deficits, flap revision surgeries, kidney damage, amputation, and even death [3,4]. Duckworth et al. began a program of repeated pressure measurement at their center [3]. Monitoring continuous pressure was shown to decrease the time to surgery and aid in diagnosis. Gold standard treatment of CS consists of emergency fasciotomy to reduce the pressure within the compartment [4]. The surgical wound often must be left open for an extended period, and the necessity for delayed closure of the wound carries a high risk of infection [4-6]. An in-depth analysis of current databases shows late diagnosis has increased complications of muscled death while still overdiagnosing CS and resulting in early prophylactic surgery [7]. Big data analyses have shown that almost one in six fasciotomies of the injuries of the leg revealed some degree of myonecrosis and 5.4% of fasciotomies led to amputations [7]. This indicates that current techniques used for the diagnosis of CS may be inadequate [7], resulting in late treatment or unnecessary interventions. This is illustrated by the fact that a missed diagnosis of CS represents a large medicolegal risk. This risk changes the way that surgeons think of the disease and changes practice to a more legal preventative course [8,9]. The use of a new micro-electrical machine system (MEMS) based pressure monitor [2] has shown good results in trauma patients [10-12]. MEMS allows the insertion of the pressure sensor and computing chip into the area of concern. Direct measurement without a column of water is much more accurate (600%) and does not require an expert in the management of the sensor and fluid column [2]. This has been seen in a quicker time to surgery, avoidance of any late CS cases, and a decrease in the number of fasciotomies – not just in the prospective cohort trials but in large clinical releases. Further publications of the larger clinical experience will better define usage.
Case Presentation The patient was a 53-year-old female, a previously healthy patient, who presented to the orthopedic team in the emergency department 12 hours after being struck by a truck while riding her bike. She had an episode of loss of consciousness at the time of the injury. Her neurological examination and head scan were negative. The patient was able to easily move her right leg without pain. The patient was not complaining of excruciating pain sometimes seen in CS. Classically pain to passive motion is seen and was not exhibited here. Pain to direct palpation over the right knee resulted in the performance of a knee and tibia radiograph (Figures 1-2).
How to cite this article Al Nasser A M, Harvey E J, Bunting A C (November 25, 2024) Early Detection of Compartment Syndrome With Minimal Symptoms: A Case Report on Continuous Pressure Monitoring. Cureus 16(11): e74453. DOI 10.7759/cureus.74453

35.1 35.1

Clinical Studies

Study

Sample Principal

Treatment/

Size Investigator Intervention

Outcome of Interest

Follow Up Time

Status

Hospital /Research Org.

Quebec Study: MY01 – 50 An Aid for diagnosing ACS in real-time

Dr. Mitchell Bernstein

Pressure monitoring with MY01 device (pressure, clinical monitoring with 7 Ps)

Development of ACS based on clinical signs and continuous pressure measurement

6 weeks

Completed

· Montreal General Hospital · Sacre-Coeur Hospital · Hôpital Enfant Jésus

COTS Study:

100

Clinical Trial of a New

Device for Real-Time

Muscle Pressure

Measurements in

Patients with an

Upper or Lower

Extremity Fracture at

Risk for Acute

Compartment

Syndrome (Leighton)

DoD Sponsored

Study: Real-Time

Muscle Pressure

Measurements in

Patients at Risk for

ACS: A Prospective

Cohort Study with

Historical Control

RESTORE – Evaluation 200 of the diagnostic and therapeutic value of tissue ultrafiltration in patients at risk of
acute compartment syndrome

Retrospective Study 133 on Tibial Fractures and Dislocations Resulting in Acute Compartment Syndrome” (Bernstein)

Dr. Ross Leighton

Pressure monitoring with MY01 device (pressure, clinical monitoring with 7 Ps)

Safety and functionality of MY01 (the device) in patients at risk
for developing acute compartment syndrome

2 weeks

Dr. Mitchell Bernstein

Pressure monitoring with MY01 device (pressure, clinical monitoring with 7 Ps)

Development of ACS based on clinical signs and continuous pressure measurement

2 weeks

Completed Completed

· Queen Elizabeth II Health Science Centre (Halifax), · St. Michael’s Hospital (Toronto, · Foothills Hospital (Calgary) · Vancouver General Hospital (Vancouver) · London Health Science Centre (London)
· Recruitment: VUMC, Hennepin (Dr Obremskey, Dr Schmidt) · Coordination: MUHC

Dr. Andrew Schmidt
Dr. Mitchell Bernstein

Tissue Ultrafiltration (TUF) and continuous compartment pressure monitoring
Clinical exam, surgical assessment

Efficacy of TUF in reducing the incidence of ACS and fasciotomy, lowering IMP, and improving functional outcomes among lower extremity injury patients.

6 months

Validation of new 6 weeks classification. 6-7p’s validation

Recruiting

· Hennepin Medical Centre · University of Maryland · Carolinas Medical Centre · Vanderbilt Medical Centre

Completed

MUHC / VUMC / Hennepin

Expert panel survey – 24 REACtS. REsearch on Acute CompartmenT Syndrome Working Group

Dr. Edward J. Harvey

Continuous monitoring of IMP

Validation of the new HOPS ACS classification classification

6 weeks

Completed

Surveying of experts from a variety of
leading trauma centers across the US and Canada.

MY01 Value Analysis | Clinical and Preclinical Evidence

Reimbursement

MY01 is reimbursable under existing CPT codes used to monitor compartment pressure. This supports a smooth integration into clinical and billing workflows while helping hospitals recover costs associated with the procedure.
Physician CPT Codes
CPT 20950 Monitoring of interstitial fluid pressure (includes insertion of device, e.g., wick catheter technique, needle manometer technique) in detection of muscle compartment syndrome. Physician Fee Schedule Payment: $88.45
CPT 76942 Ultrasonic guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), imaging supervision and interpretation. Physician Fee Schedule Payment: $52.71 (based on a 1.61 RVU – subject to insurer changes)

Outpatient & ASC Facility Reimbursement

MY01 is also recognized under hospital outpatient and ambulatory surgery center (ASC) payment systems using the same CPT code.

Setting Hospital Outpatient Ambulatory Surgery Center

Payment System OPPS (APC 5071, Status Indicator T) ASC (Payment Indicator G2)

Code CPT 20950 CPT 20950

Payment Rate $648.97 $337.92

Inpatient Setting
When MY01 is used in an inpatient case, reimbursement is bundled into the hospital’s MS-DRG based on diagnosis and procedures. MY01 aligns with DRGs such as:
· DRG 480482: Hip and femur procedures · DRG 492494: Lower extremity and humerus procedures · DRG 500502: Soft tissue procedures · DRG 907909: Other O.R. procedures for injuries · DRG 957959: Multiple significant trauma

MY01 Value Analysis | Reimbursement

Regulatory

Clearances

Device name: MY01 Continuous Compartment Pressure Monitor 510 (K) number: K242997 Device classification name: Monitor, pressure, intracompartmental. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K210525

MY01 | FDA 510(k) Clearance

MY01 Breakthrough Device Designation

MY01 Inc. Olivier Bataille Chief Operating Officer 400 De Maisonneuve Boulevard West, Suite 700 Montreal, QC H3A 1L4 Canada

March 13, 2025

Re: K242997 Trade/Device Name: MY01 Continuous Compartmental Pressure Monitor Regulatory Class: Unclassified Product Code: LXC Dated: September 26, 2024 Received: February 11, 2025

Dear Olivier Bataille:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

Doc ID# 04017.07.05

CE Mark (36359)

Manufacturing – ISO13485:2016 Certified (36360)

MY01 Inc. Anthony Sirgi Regulatory Affairs and Quality Manager 400 De Maisonneuve Boulevard West Suite 700 Montréal, Quebec H3A 1L4 Canada

October 20, 2021

Re: Q211914 Trade/Device Name: MY01 Continuous Compartmental Pressure Monitor Received: September 20, 2021

Dear Anthony Sirgi:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has received the above submission requesting designation as a Breakthrough Device. The proposed indications for use includes “MY01 device is used for real-time and continuous measurement of muscle pressures. The measured muscle pressure can be used as an aid in the diagnosis of acute compartment syndrome (ACS). The MY01 Mobile Application is an application intended for storing and displaying identical pressure values from the MY01 device and calculating critical muscle perfusion pressure utilizing diastolic pre ssure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.” We are pleased to inform you that your device and proposed indication for use meet the criteria and have been granted designation as a Breakthrough Device. Please refer to the FDA guidance document entitled “Breakthrough Devices Program”, for more information regarding the program, available at https://www.f da.gov/media/108135/download .

We recommend you review the FDA guidance document for the Breakthrough Devices Program referenced above for the available mechanisms for obtaining feedback from the Agency on device development for designated breakthrough devices. When submitting any new requests, please reference Q211914. Any new submission should be provided as an eCopy, it should include the FDA reference number for this submission, and should be submitted to the following address:

U.S. Food and Drug Administration Center for Devices and Radiological Health IDE Document Control Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

We have noted that your business resides outside of the United States. Please be advised that if you need to conduct a clinical study in the United States that the IDE regulations do not permit foreign entities to sponsor clinical studies in the U.S. (21 CFR 812.18(a)). Instead, a foreign company must have a U.S. agent who acts

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

Do c ID# 0 4 0 1 7 .04 .2 8

HC Approved (LN/NH 104256)

Santé Health Canada Canada

LN/NH: 104256

Medical Devices Directorate Direction des instruments médicaux

Medical Device Licence

Homologation d’un instrument médical

* AMENDED * Licence Number:
First Issue Date: Amended Date:

104256 2020/02/04 2025/03/24

* MODIFIÉE * No d’homologation: Première date de délivrance: Date de modification:

Device Class/Classe de l’instrument: 2

This Licence is issued in accordance with the Medical Devices Regulations, Section 36, for the following medical device:

La présente homologation est délivrée en vertu de l’article 36 du Règlement sur les instruments médicaux pour l’instrument médical suivant:

Licence Name/Nom de l’homologation: MY01 CONTINUOUS COMPARTMENTAL PRESSURE MONITOR
Licence Type/Type d’homologation: System / Système
Reason for Amendment/Raison de la modification CHANGE TO THE PURPOSE/INDICATION OF LICENSE; ADDITION OF A DEVICE; CHANGE TO LICENCE
TYPE
Manufacturer Name & Address/Nom du fabricant & adresse MY01 INC.
400 DE MAISONNEUVE BOULEVARD WEST SUITE 700 MONTREAL, QUEBEC CANADA H3A 1L4 Colin Foster, Director, Bureau of Medical Device Licensing Services Directeur, Bureau des services d’homologation des instruments médicaux
_________________________________________________________

Application Number: Numéro de la demande:

392848

Manufacturer ID: Identificateur du fabricant:

148012

Audit – MDSAP (36361-1)

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In the issuance of this certificate Intertek assumes no liability to any arty other than to the lient and then only in accordance with the agreed u on ertification greement his certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification alidity may be confirmed via email at certificate validation intertek com or by scanning the code to the right with a smart hone he certificate remains the ro erty of Intertek to whom it must be returned u on request

MY01 Value Analysis | Regulatory Clearances

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In the issuance of this certificate Intertek assumes no liability to any arty other than to the lient and then only in accordance with the agreed u on ertification greement. his certificate’s validity is subject to the organization maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may be confirmed via email at certificate.validation intertek.com or by scanning the code to the right with a smart hone. he certificate remains the ro erty of Intertek to whom it must be returned u on request. Validity of this certificate may be verified at htt www.intertek.com business assurance certificate validation
. an.

Training and Education

Medical Education
MY01 offers a myriad of education options for all levels of healthcare providers designed to increase competence and confidence in the MY01 device, aiding diagnosis of acute compartment syndrome. Included in these offerings are on-demand materials and virtual events, as well as in-person didactic and hands-on device training engagements provided by MY01 personnel.
Safe and effective utilization of the MY01 device is our highest priority, a theme present throughout the training. The clinical pathway is a continuum of learning starting with the basics and developing to more advanced material with an emphasis on evolving and current content to meet the needs of the health care provider to aid in patient care.
MY01 Self Training can be accessed at any time via the MY01 website, where you can instantly download the Device Instructions for Use Manual as well as engage in the MY01 onboarding training.

MY01 Clinical Pathway

Phase 1

Self-Led Onboarding Training · MY01 device safe use video · Review of MY01 device user manual · Review MY01 App user manual · MY01 compartment syndrome data

Phase 2

Live Didactic Training · Schedule with local MY01 representative · Tailored content delivered in-person or virtually
o Patient assessment o Evaluation of pressures o At risk patient populations
o Continuous monitoring leads to better outcomes o Closing the loop

Phase 3

Clinical Integration · Schedule with local MY01 representative · Medical Education and Account Manager led instruction
o Performance Improvement Plan o Hands-On Training o App overview and user integration o Clinical Practice Guidelines, templates for PI auditing and reporting

Phase 4

Continuing Education · On-demand videos and webinars · Live Webinars · Newly published data and abstracts · Live Education Summits

MY01 Value Analysis | Training and Education

Sources
1. Schmidt, A.H., Acute Compartment Syndrome. Orthopedic Clinics of North America, 2016. 47(3): p. 517-525. 2. McQueen, M.M., et al., Predictors of Compartment Syndrome After Tibial Fracture. J Orthop Trauma, 2015. 29(10): p. 451-5. 3. McQueen, M.M., P. Gaston, and C.M. Court-Brown, Acute compartment syndrome. Who is at risk? J Bone Joint Surg Br, 2000. 82(2): p. 200-3. 4. Ulmer, T., The clinical diagnosis of compartment syndrome of the lower leg: are clinical findings predictive of the disorder? J Orthop Trauma,
2002. 16(8): p. 572-7. 5. Lorange, J.-P., et al., Diagnosis Accuracy for Compartment Syndrome: A Systematic Review and Meta-Analysis. Journal of Orthopaedic Trau-
ma, 2023. 37(8): p. e319-e325. 6. Farber, A., et al., Early fasciotomy in patients with extremity vascular injury is associated with decreased risk of adverse limb outcomes: a
review of the National Trauma Data Bank. Injury, 2012. 43(9): p. 1486-91. 7. McCallum, J.R., et al., Return to duty after elective fasciotomy for chronic exertional compartment syndrome. Foot Ankle Int, 2014. 35(9): p.
871-5. 8. Rothenberg, K.A., et al., Delayed Fasciotomy Is Associated with Higher Risk of Major Amputation in Patients with Acute Limb Ischemia.
Annals of Vascular Surgery, 2019. 59: p. 195-201. 9. Vaillancourt, C., et al., Acute compartment syndrome: how long before muscle necrosis occurs? CJEM, 2004. 6(3): p. 147-54. 10. Bouklouch, Y., et al., Big data insights into predictors of acute compartment syndrome. Injury, 2022. 11. Cone, J. and K. Inaba, Lower extremity compartment syndrome. Trauma Surg Acute Care Open, 2017. 2(1): p. e000094. 12. Chung, K.C., et al., A cost-utility analysis of amputation versus salvage for Gustilo type IIIB and IIIC open tibial fractures. Plast Reconstr Surg,
2009. 124(6): p. 1965-1973. 13. Bhattacharyya, T. and M.S. Vrahas, The medical-legal aspects of compartment syndrome. J Bone Joint Surg Am, 2004. 86(4): p. 864-8. 14. Little, M.T.M., C.A. Lin, and M.S. Vrahas, Legal Aspects of Compartment Syndrome, in Compartment Syndrome: A Guide to Diagnosis and
Management, C. Mauffrey, D.J. Hak, and I.M. Martin, Editors. 2019: Cham (CH). p. 9-16. 15. Osborn, C.P.M. and A.H. Schmidt, Management of Acute Compartment Syndrome. J Am Acad Orthop Surg, 2019. 16. Bouklouch, Y., et al., Postfasciotomy Classification System for Acute Compartment Syndrome of the Leg. J Orthop Trauma, 2023. 37(11): p.
581-585. 17. Schmidt, A.H., The impact of compartment syndrome on hospital length of stay and charges among adult patients admitted with a fracture
of the tibia. J Orthop Trauma, 2011. 25(6): p. 355-7. 18. Crespo, A.M., et al., Development of Compartment Syndrome Negatively Impacts Length of Stay and Cost After Tibia Fracture. J Orthop
Trauma, 2015. 29(7): p. 312-5. 19. Iskandar, K., et al., Highlighting the gaps in quantifying the economic burden of surgical site infections associated with antimicrobial-resis-
tant bacteria. World J Emerg Surg, 2019. 14: p. 50. 20. McQueen, M.M., et al., The estimated sensitivity and specificity of compartment pressure monitoring for acute compartment syndrome. J
Bone Joint Surg Am, 2013. 95(8): p. 673-7. 21. Powell-Bowns, M.F.R., et al., Tibial shaft fractures – to monitor or not? A multi-centre 2 year comparative study assessing the diagnosis of
compartment syndrome in patients with tibial diaphyseal fractures. Injury. 22. Merle, G., et al., Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome. Military Medicine, 2020. 185(Supple-
ment_1): p. 77-81. 23. O’Toole, R.V., et al., Variation in diagnosis of compartment syndrome by surgeons treating tibial shaft fractures. J Trauma, 2009. 67(4): p.
735-41. 24. Balhareth, M.A., et al., Clinical trial of a new continuous compartment pressure monitoring to aid in the diagnosis of Acute Compartment
Syndrome. J Orthop Trauma, 2025. 25. Bouklouch, Y. and M.K. Sen, Acute Compartment Syndrome Diagnosis: The Cost Benefits of Continuous Pressure Monitoring. Journal of
Bone and Joint Surgery, 2025. Accepted

MY01 Value Analysis | Sources

400 Boul de Maisonneuve Ouest, Suite 700, Montréal, QC H3A 1L4

855-799-6901

info@my01.io

my01.io

MRKT-PRMA-010 Rev.1

Documents / Resources

MY01 Device and App Repository [pdf] User Guide
Device and App Repository, and App Repository, App Repository

References

User Manual

MY01 Device and App Repository User Guide

Device and App Repository

Product Information

Specifications

Product Usage Instructions

Overview

Steps for Usage

Clinical Benefits

Frequently Asked Questions (FAQ)

Q: How does the Continuous Perfusion Sensing Technology
Platform help in trauma care?

Q: What are the consequences of late diagnosis and treatment of
acute compartment syndrome?

Documents / Resources

References

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