Abbott Assert-IQ™ Insertable Cardiac Monitor
Model DM5000, DM5300, DM5500
Overview
The Assert-IQ™ Insertable Cardiac Monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net™ Patient Care Network (PCN) for patients experiencing symptoms that may be cardiac-related, at risk for abnormal cardiac rhythms, or previously diagnosed with or susceptible to developing atrial fibrillation (AF).
Product Highlights
Device
- Slim design allowing for a simple insertion procedure with minimal time and resources, unnoticeable in most patients after insertion.
- Longest lasting Bluetooth® ICM, offering full functionality without compromises.
- Advanced algorithms reduce false detections by 98.7% for AF and Pause, while maintaining 97.7% of true events.
- Key Episode technology allows clinicians to view all episodes or 3 Key Episodes based on patient or clinic needs.
- Clear, crisp EGMs provide improved visualization of P-waves, potentially leading to faster care decisions.
- Remote Programming allows clinicians to adjust device settings, optimize performance, and limit unnecessary alerts or transmissions without requiring patient visits.
- IQ Insights enables data-driven decisions with additional sensors capturing diagnostics like leading premature ventricular contraction (PVC) detection algorithms for consecutive events, couplets, and triplets.
- Body Position & Posture at episode onset helps assess other patient factors during episode adjudication.
- Tracks elevated heart rate with and without activity.
- Provides AF Burden, trending, and more.
- Device is 1.5 Tesla (T) and 3T MR Conditional.
Mobile App and Connectivity
- Bluetooth wireless technology connects the ICM to the myMerlin™ Mobile App, downloadable onto a patient's smartphone. No separate bedside transmitter or patient activator is needed.
- Advanced Bluetooth technology checks the device every 20 seconds, ensuring data is captured, encrypted, and transferred to the Merlin.net PCN quickly and easily.
- The ICM continuously monitors rhythm, and the myMerlin Mobile App proactively transmits data based on clinic-defined schedules and alerts.
- The myMerlin Mobile App includes integrated activator functionality for patients to privately record and transmit EGMs during symptoms.
- App notifications inform patients of daily device checks and scheduled transmissions to promote remote monitoring adherence without burdening the clinic.
- Over 35 languages are available on the myMerlin Mobile App for personalized patient engagement.
- Abbott mobile transmitters are available for patients without their own compatible mobile device.
Ordering Information
Contents: ICM device, insertion tool, and incision tool
| MODEL NUMBER | DESCRIPTION | DIMENSIONS (H x L x T, мм) | WEIGHT (G) | VOLUME (CM³) | LONGEVITY |
|---|---|---|---|---|---|
| DM5000 | Assert-IQ™ ICM 3 | 46.5 x 9.4 x 3.1 | 2.9 | 1.2 | 3 years |
| DM5300 | Assert-IQ™ ICM 3+ | 46.5 x 9.4 x 3.1 | 2.9 | 1.2 | 3 years |
| DM5500 | Assert-IQ™ ICM EL+ | 49 x 9.4 x 4.4 | 3.7 | 1.9 | 6 years |
Physical Specifications
| Parameter | Settings |
|---|---|
| Model Number | DM5000, DM5300, DM5500 |
| Device Coating | Parylene |
| Raised Header Electrode | 37 mm² |
| Surface Area | Bluetooth® |
| Telemetry | Bluetooth® |
Parameter Specifications
| Parameter | Settings |
|---|---|
| Nominal Settings | |
| Sense Refractory Period | 250 ms |
| Sensing Sensitivity | 0.125 mV |
| Programmable Settings | |
| Sense Refractory Period | 125-400 ms in increments of 25 ms |
| Sensing Sensitivity | 0.05-0.3 mV in increments of 0.025 mV |
| AF | On; Off |
| AF Sensitivity | Least, Less, Balanced, More |
| AF Duration | 30 sec, 1, 2, 6, 10, 20, 30, 60 min |
| AF Burden Alert | Off, 30 min, 1, 3, 6, 9, 12, 24 hrs |
| AF Continuous Episode Alert | Off, 1, 2, 6, 10, 20, 30, 60, 180 min |
| Ventricular Rate during AF Alert Rate Threshold | 90, 100, 110, 120, 130, 140, 150, 175, 200 bpm |
| Total Time | 1, 3, 6, 9, 12 hrs |
| Tachy | |
| EGM Storage | On; Off |
| Rate | 120-250 bpm in increments of 5 bpm |
| Duration | 8-24 intervals in increments of 1; 25-50 intervals in increments of 5 |
| Sudden Onset | On; Off |
| % Delta | 4-86% in increments of 2 |
| Bigeminy Qualifier | On; Off |
| Brady | |
| EGM Storage | On; Off |
| Rate | 30, 40, 50 bpm |
| Pause | On; Off |
| EGM Storage | 2, 3, 4, 5, 6, 7, 8 sec |
| Diagnostics | |
| Reason for Monitoring Selection | Syncope, Palpitations, Seizures, Ventricular Tachycardia, Suspected AF, Post AF Ablation, AF Management, Cryptogenic Stroke, Other |
| PVC Burden* | On; Off |
| Activity Trends | On; Off |
| Posture at Episode Onset* | On; Off |
| Total EGM Storage | 60 min |
| Symptom EGM Duration | Pre-Trigger: 4, 6, 7, 10, 12, 14 min Post-Trigger: 30, 40, 50, 60 sec |
| Device Detected EGM Duration | 10, 20, 30, 60, 90, 120 sec |
| AF Pre- and Post-Trigger | 10, 20, 30, 60, 90, 120 sec |
| Other Pre- and Post-Trigger (Tachy, Brady, Pause) | 10, 20, 30, 40, 50, 60 sec |
| Heart Rate Histogram | Yes |
| AF Diagnostics | Yes |
| AF Burden Trend | Yes |
| Other Features | |
| Patient Trigger | Yes |
| Remote Monitoring | myMerlin App via Bluetooth wireless technology |
| Remote Programming* | Merlin.net Patient Care Network (PCN) |
Longevity provided under the following usage scenarios: Average of 1 auto-detected episode per day, Average 1 patient-activated symptom episode per month, Up to 6 month shelf storage time.
Security Measures
- The ICM encrypts its wireless communication and patient health information (PHI) data both at rest and in-transit from ICM to the myMerlin™ Mobile App and Merlin.net™ Patient Care Network (PCN) using AES 128-bit encryption with TLS 1.2.
- AES 128-bit encryption limits communication to a single authenticated and paired app transmitter.
- The ICM uses a pairing procedure specified in Bluetooth® wireless technology low energy protocols and a proprietary pairing protocol with certificate-based public key cryptography authentication.
- The ICM creates and verifies a unique 128-bit key for the paired mobile app at the onset of every communication. Access is denied if the key is not verified.
- The ICM uses an authorization protocol to limit a paired mobile app's access.
- Firmware upgrades for the ICM are cryptographically authenticated before installation.
- Remote programming commands created by an authorized clinician are cryptographically authenticated by the ICM.
- The Merlin.net PCN is housed in a secured data center and is ISO27001:2013 certified. Access to patient data is restricted to authorized users as set by the clinic administrator.
References
- Abbott. Assert-IQ ICM User Manual.
- Medtronic. REVEAL LINQ LNQ11 Insertable Cardiac Monitor and Patient Assistant PA96000 Clinician Manual. Updated August 26, 2015.
- Medtronic. LINQ II LNQ22 Insertable Cardiac Monitor Clinician Manual. Updated September 01, 2022.
- Boston Scientific. User's Manual, Lux-Dx Insertable Cardiac Monitor System M301, 2925, 2935. Updated July 2020.
- Biotronik. Technical Manual BioMonitor III. Updated December 10, 2020.
- Biotronik. Technical Manual BioMonitor IIIm². Updated December 10, 2020.
- Gopinathannair R, Lakkireddy D, Manyam H, et al. Improving the Specificity of Atrial Fibrillation and Tachycardia Detection in an Insertable Cardiac Monitor. Presented at Heart Rhythm Society (HRS); San Francisco, USA; 2022.
- Afzal MR, Gopinathannair R, Manyam H, et al. Development and Evaluation of A New Algorithm Enhancement to Improve Specificity of Pause Detection in an Insertable Cardiac Monitor. Presented at Heart Rhythm Society (HRS); San Francisco, USA; 2022.
- Data on File. Abbott - Report SJM-CFM-0919-0163.
- Gardner RS, Quartieri F, Betts TR, et al. Reducing the Electrogram Review Burden Imposed by Insertable Cardiac Monitors. J Cardiovascular Electrophysiology. 2022;33(4):741-750. doi:10.1111/jce.15397
- Shehata MM, Nair DG, Qu F, et al. Insertable Cardiac Monitor P-wave Visibility in a New Clinical Report. Presented at Asia Pacific Heart Rhythm Society (APHRS); Bangkok Thailand; 2022.
- Manyam H, Afzal MR, Gopinathannair R, et al. Evaluation of A Novel Premature Ventricular Contraction Detection Algorithm in An Insertable Cardiac Monitor. Presented at Heart Rhythm Society (HRS); San Francisco, USA; 2022.
Rx Only
Brief Summary
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications for Use
The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.
Intended Use
The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.
Contraindications
There are no known contraindications for the insertion of the Assert-IQ ICM. However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Potential Adverse Events
Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation and migration.
Refer to the User's Manual for detailed indications for use, contraindications, warnings, precautions and potential adverse events.
*Indicates available on DM5300/DM5500
