Jeffery Gonya AtriCure, Inc.
CEM-265.D en English Summary of Safety and Clinical Performance (SSCP)
AtriCure EPi-Sense Coagulation System
05 May 2023 CEM-265 Revision D
AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
OVERVIEW This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to
an updated summary of the main aspects of the safety and clinical performance of the device.
The SSCP is not intended to replace the Instructions for Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients.
INFORMATION INTENDED FOR USERS/ HEALTHCARE PROFESSIONALS:
1. Device identification and general information
Product name
EPi-Sense® Coagulation Device (product code CDK1413) EPi-Sense STTM Coagulation Device (product code EPiST): Cannula with Guide (product code CSK-6131)
Product group/family Basic UDI-DI
EPi-Sense Coagulation Device (CDK-1413): 08401439000000000000010ZC EPi-Sense ST Coagulation Device (EPiST): 08401439000000000000010ZC Cannula with Guide (CSK-6131): 08401439000000000000012ZG
Manufacturer legal name, address, and Single Registration Number (SRN)
AtriCure 7555 Innovation Way Mason, OH 45040 USA SRN: US-MF-000002974
EU Authorised Representative name, address, and Single Registration Number (SRN)
European Medical Device Nomenclature (EMDN) code and description
AtriCure Europe B.V. De entree 260 1101 EE Amsterdam NL SRN: NL-AR-000000165
EPi-Sense Coagulation Device: C020301 Cardiac Tissue Ablation Electrocatheters, Radiofrequency EPi-Sense ST Coagulation Device: C020301 Cardiac Tissue Ablation Electrocatheters, Radiofrequency Cannula with Guide: V9012 Surgical Instruments, Not Specialist Surgery, Single-Use
Product classification and rule (per MDR)
Year when the first certificate (CE) was issued covering the device
EPi-Sense Coagulation Device: Class III, Rule 7 EPi-Sense ST Coagulation Device: Class III, Rule 7 Cannula with Guide: Class III, Rule 7
EPi-Sense Coagulation Device: 2011 EPi-Sense ST Coagulation Device: Under review for initial CE marking Cannula with Guide: 2006
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Notified Body name, address, and number
BSI Say Building John M. Keynesplein 9 1066 EP Amsterdam NL +31 20 346 0780 CE 2797
2. Intended use of the device 2.1 Intended Purpose EPi-Sense Coagulation Device: The EPi-Sense Coagulation Device is intended for the ablation of cardiac tissue using radiofrequency (RF) energy.
EPi-Sense ST Coagulation Device: The EPi-Sense ST Coagulation Device is intended for the ablation of cardiac tissue using radiofrequency (RF) energy.
Cannula with Guide: The Cannula with Guide is intended for endoscopic use to provide cardiothoracic surgical access.
2.2 Indication(s) and target populations EPi-Sense Coagulation Device: · Indication: Epicardial treatment of atrial fibrillation, including when augmented with an endocardial ablation, with the aim to restore normal sinus rhythm (i.e., freedom from AF/AFL/AT), reduce AF symptoms, and improve quality of life. · Target Population: Patients with arrhythmias including atrial fibrillation
EPi-Sense ST Coagulation Device: · Indication: Epicardial treatment of atrial fibrillation, including when augmented with an
endocardial ablation, with the aim to restore normal sinus rhythm (i.e., freedom from AF/AFL/AT), reduce AF symptoms, and improve quality of life. · Target Population: Patients with arrhythmias including atrial fibrillation
Cannula with Guide: · Indication: Endoscopic use to provide cardiothoracic surgical access during minimally
invasive procedures for the treatment of arrhythmia. · Target population: Patients who are undergoing epicardial ablation for the treatment of
arrhythmia.
2.3 Contraindications and/or Limitations EPi-Sense and EPi-Sense ST Coagulation Devices: Patients with presence of left atrial thrombus, a systemic infection, active endocarditis, or another infection local to the surgical site at the time of surgery. Patients with Barrett's Esophagitis.
Cannula with Guide: There are no known contraindications.
3. Device description
3.1 Description of the device
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
EPi-Sense Coagulation Device and EPi-Sense ST Coagulation Device
The EPi-Sense Coagulation Device (Figure 1) and EPi-Sense ST Coagulation Device (Figure 2) are sterile, single-use coagulation probes with electrodes at the distal end. The probes have a flexible, multi-lumen silicone shaft that provides separate paths for vacuum, perfusion, and a guidewire. The handles at the proximal end of the probes incorporate a connector for the compatible AtriCure RF generator, a port for connection to a commercially available vacuum pump, a connection for saline for perfusion, and a port for a guidewire to exit.
The probes integrate a 3 cm coagulation electrode and sensing electrodes at the distal end. A flexible, multi-lumen shaft provides a path for vacuum (suction), saline perfusion, and a guidewire. Once the probe is inserted and placed on the epicardial surface of the heart, vacuum is applied, and suction at the distal end of the probe brings the tissue into direct engagement with the coagulation electrode. When connected, a compatible AtriCure RF generator transmits energy to the coagulation device and into the contacted tissue, causing necrosis and creating lesions originating on the epicardium. Throughout the process, saline is perfused through the probe when the vacuum is applied and the saline stopcock provided with the device is open.
The EPi-Sense Coagulation Device is gamma sterilised, and the EPi-Sense ST is sterilised using ethylene oxide. These devices are not made with natural rubber latex or polyvinyl chloride (PVC). They do not contain phthalates. They are not made with animal tissuederived materials. These devices include stainless steel, which contains nickel and cobalt. Nickel is a known allergen, and cobalt is registered in the European Union as a CMRi substance of concern. The Coagulation Devices contain small amounts of nickel and cobalt; thus, the devices should not be used if the patient has sensitivity to nickel or cobalt, as this may result in an adverse patient reaction.
Figure 1: EPi-Sense Coagulation Device
Figure 2: EPi-Sense ST Coagulation Device
i CMR refers to Carcinogenic, Mutagenic, or Toxic for Reproduction. _____________________________________________________________________________
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Cannula with Guide
The Cannula is a sterile, single-use access tool used to introduce the EPi-Sense or EPiSense ST Coagulation Device into the chest cavity. The Cannula is 30 cm long with a large, central, flexible lumen to accommodate both the probe and a commercially available endoscope for visualization. Access to the pericardial space and the epicardial surface of the heart is accomplished using standard surgical techniques such as a sub-xiphoid approach.
The Cannula (Figure 3) is comprised of a distal tip, a shaft with a textured grip at the proximal end, a vacuum line, and an integrated guidewire.
The Cannula incorporates a vacuum port at the proximal end that attaches to a commercially available vacuum pump. Suction is used to remove fluids for better visualization in the pericardial space. The device also incorporates an integrated guidewire. The Coagulation Devices can be placed over the guidewire through the Cannula.
The Cannula is gamma sterilised. The Cannula is not made with natural rubber latex and does not contain PVC or phthalates. It does not contain animal-derived tissues. The Cannula includes Nitinol and thus contains nickel, which is an allergen. The Cannula contains small amounts of nickel and thus should not be used if the patient has sensitivity to nickel, as this may result in an adverse patient reaction.
Figure 3: Cannula with Guide
Principles of Operation
The EPi-Sense Coagulation System utilizes the well-established technologies of RF coagulation, suction, and perfusion.
The Cannula is an access tool to insert the probe into the patient's chest cavity. The coagulation probe and a commercially available endoscope are inserted through the main lumen of the Cannula. The probe may also be inserted directly through the lumen or over the incorporated guide wire which is then fed back through the lumen. A vacuum line in the Cannula provides for fluid removal using suction.
The coagulation probe is inserted into a body cavity under visualization using endoscopic surgical techniques. The distal end of the probe is placed in contact with the epicardial surface of the heart.
Vacuum is applied through the probe during coagulation to ensure solid tissue engagement
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
for consistent lesions. As vacuum is applied via the vacuum lumen of the probe, tissue is brought into direct engagement with the coil electrode.
RF energy from the generator is transmitted to the coil electrode of the ablation probe. The application of RF energy into the tissue causes coagulation necrosis and creates lesions on the epicardial surface of the heart.
Throughout the coagulation process, saline is perfused through the probe. Applied vacuum pulls saline through the probe. During coagulation, the saline cools the non-tissue-contacting surface of the coagulation device and inhibits excessive heating at the probe and tissue interface.
3.2 A reference to previous generation(s) or variants if such exist, and a description of the differences
EPi-Sense Coagulation Device (CDK-1413)ii · Change of sterile barrier packaging to tray within a pouch · Extension of shelf life from 1 to 3 years · Interface increased between PEEK tubing and molded plug for guidewire (distal end) · Addition of 6 visual dots on external device shaft due to market feedback · Addition of polycarbonate Tuohy borst valve due to market feedback
EPi-Sense ST Coagulation Device (EPiST)iii · Shaft length increased for ease of use · Addition of thermistor, temperature control circuit board, and LED light to alert user to suboptimal device perfusion · Addition of distal tip bidirectional deflection due to market feedback · Addition of deflection and locking capability to handle due to market feedback · Distal tip changed to anchor bidirectional deflection capability · New RF cable to accommodate battery for temperature control circuit and LED light · Change to main body tubing to accommodate thermistor wires · Addition of grey polyolefin over-jacket to maintain rigidity of additional length · Addition of 5 additional reference dots due to market feedback · Change to ethylene oxide sterilization due to added components for thermistor functionality
ii The listed changes have been introduced to CDK-1413 since its introduction to market, with no
change to the product code. iii The listed changes appear in EPiST and reflect changes from its predicate device, CDK-1413.
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Cannula with Guide (CSK-6131)iv
· Shortening the shaft and internal spring to prevent user damage to spring and encapsulant during use with endoscope
· Lengthening the molded tip to maintain device length
· Additional lumens in the molded tip to add Nitinol (NiTi) wires with polyimide tubes
· Shortening of the stainless steel distal wire
3.3 Description of any accessories which are intended to be used in combination with the device
For use with the EPi-Sense Coagulation Device:
Required
· CSK-2000 (Basic UDI-DI: 08401439000000000000011ZE) is a required accessory for use with the EPi-Sense Coagulation Device. CSK-2000 is a sterile, single-use radiofrequency cable manufactured by AtriCure, Inc., which is required to transmit RF energy from the compatible AtriCure RF Generator to the attached EPi-Sense Coagulation Device.
Recommended/Optional
· The External Graphics Display Software (LPK-302; Basic UDI-DI: 08401439000000000000009ZT) is an optional accessory manufactured by AtriCure, Inc., which is intended to be used in conjunction with the CSK-310 AtriCure RF Generator System and the Coagulation Device to display the energy delivered during each ablation.
For use with the EPi-Sense ST Coagulation Device:
Required
· CSK-2060 (Basic UDI-DI: 08401439000000000000011ZE) is a required accessory for use with the EPi-Sense ST Coagulation Device. CSK-2060 is a sterile, single-use radiofrequency cable manufactured by AtriCure, Inc., which is required to transmit RF energy from the compatible AtriCure RF Generator to the attached EPi-Sense ST Coagulation Device.
Recommended/Optional
· The External Graphics Display Software (LPK-302; Basic UDI-DI: 08401439000000000000009ZT) is an optional accessory manufactured by AtriCure, Inc., which is intended to be used in conjunction with the CSK-310 AtriCure RF Generator System and the Coagulation Device to display the energy delivered during each ablation.
For use with the Cannula with Guide:
Required
· None; refer to Section 3.4.
Recommended/Optional
iv The listed changes indicate design changes in CSK-6130, which is now given the product code CSK-6131 under EU MDR. _____________________________________________________________________________
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
· None; refer to Section 3.4.
3.4 Description of any other devices and products which are intended to be used in combination with the device
For use with the EPi-Sense Coagulation Device: Required · Compatible AtriCure RF Generator Systemv (CSK-310; Basic UDI-DI: 08401439000000000000008ZR), Non-Sterile, Reusable · Indifferent Patient Return Electrode (Ground Pad) surface area of 21 square inches (136 cm2) minimum · CSK-6131 Cannula with Guide Sterile, Single Use · 0.9% Normal Saline Solution (250 mL bag recommended) · Sterile Perfusion/IV Tubing Set (10 Drops/mL) · Sterile Vacuum Tubing Set · Vacuum regulated to -400 mmHg (-7.7 psi; -53 kPa) Recommended/Optional · 0.035 in (0.89 mm) x 39.4 in (100 cm) "J" Guide Wire · Sterile Water (For cannula flooding only) · Endoscope - see Cannula IFU scope recommendations · Temporary external electrogram recording device that meets the following specifications: Complies with IEC 60601-1 and system accepts shielded 2mm (0.08 in) pin connectors
For use with the EPi-Sense ST Coagulation Device: Required · Compatible AtriCure RF Generator System (CSK-310; Basic UDI-DI: 08401439000000000000008ZR), Non-Sterile, Reusable · Indifferent Patient Return Electrode (Ground Pad) surface area of 21 square inches (136 cm2) minimum · CSK-6131 Cannula with Guide Sterile, Single Use · 0.9% Normal Room Temperature Saline Solution (250 mL bag recommended) · Sterile Perfusion/IV Tubing Set (10 Drops/mL) · Sterile Vacuum Tubing Set · Vacuum regulated to -400 mmHg (-7.7 psi; -53 kPa)
v A pneumatic footswitch and the CSK-2030 non-sterile, reusable sensing cable are optional components included with the CSK-310 RF Generator System.
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Recommended/Optional
· 0.035 in (0.89 mm) x 39.4 in (100 cm) Guide Wire
· 5 mm (0.2 in) Endoscope
· Temporary external electrogram recording device that meets the following specifications: Complies with IEC 60601-1 and system accepts shielded 2mm (0.08 in) pin connectors
For use with the Cannula with Guide:
Required
· Vacuum Tubing Set (Sterile)
· Vacuum regulated at -250 mmHg (-4.8 psi, -33 kPa)
Recommended/Optional
· 35 or 45 cm (13.8 or 17.7 in) long, 5 or 10 mm (0.2 or 0.4 in) diameter Scope, depending on Cannula use
· 1000 mL 0.9% Normal Saline or Sterile Water
· Coagulation Device Refer to Instructions for Use for the Coagulation Device when being used with the Cannula with Guide.
4. Risks and warnings 4.1 Residual risks and undesirable effects
Coagulation Devices (CDK-1413 and EPiST)
Potential complications
Probability of occurrence 30 days
Infection
<0.1%, less than 1 in 1,000 patientsa
Cardiac tamponade/perforation
3.9%b
Pulmonary vein stenosis
<0.1%, less than 1 in 1,000 patientsa,c
Vessel injury
<0.1%, less than 1 in 1,000 patientsa
Pericardial effusion
3.9%b
Tissue perforation
<0.1%, less than 1 in 1,000 patientsa,c
Excessive bleeding
1%d
Phrenic nerve injury
1%e
Left atrial rupture/perforation
<0.1%, less than 1 in 1,000 patientsa
Mediastinitis
<0.1%, less than 1 in 1,000 patientsa
Pulmonary edema
<0.1%, less than 1 in 1,000 patientsa
Vascular access complication
0.2-1.5%f
Stroke/TIA
2%g
Incisional herniation
1.5%h
Esophageal injury
<0.1%, less than 1 in 1,000 patientsa
Pleural effusion
<0.1%, less than 1 in 1,000 patientsa
Atrio-Esophageal fistula
<0.1%, less than 1 in 1,000 patientsa,c
Cardiac arrest/Myocardial infarction
0%c
New arrhythmias
<0.1%, less than 1 in 1,000 patientsa
Thromboembolic complication
2%g
Neurologic complication
2%g
Death
<0.1%, less than 1 in 1,000 patientsa,c,i
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Complete heart block requiring pacemaker
<0.1%, less than 1 in 1,000 patientsa
implantation
Pericarditis
0.3%j
Serious skin burn
<0.1%, less than 1 in 1,000 patientsa
Transdiaphragmatic herniation
1.5%h
Damage (e.g., burn, puncture) to other
<0.1%, less than 1 in 1,000 patientsa
adjacent structures
a Estimated rate based on complaints/commercial rate. These data may be underreported.
b Occurrence rate of pericardial effusions with tamponade physiology from CONVERGE trial:
3.9% (4/102).
c Occurrence rate from CONVERGE clinical trial: 0%. d Occurrence rate from CONVERGE clinical trial: 1% (n=1/102); one additional patient had
excessive bleeding with late pericardial effusion and is included in the pericardial effusion
event rate.
e Occurrence rate of phrenic nerve injury from CONVERGE trial: 1% (n=1/102).
f Estimated rate from 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement
on Catheter and Surgical Ablation of Atrial Fibrillation (Calkins et al. 2017. Heart Rhythm.
14(10), e275-e444). g Occurrence rate from CONVERGE clinical trial: 1% (n=1/102) stroke; 1% (n=1/102) transient
ischemic attack. h Based on systematic literature review results for Cannula used with EPi-Sense Coagulation
System. The incidence of incisional hernias has been associated with trans-diaphragmatic
pericardial access; sub-xiphoid access is more commonly used in contemporary best practice.
i Deaths reported as complaints were not related to device malfunction or attributable to the
use of the device.
j Based on systematic literature review results for EPi-Sense Coagulation System.
Note: EPi-Sense was used commercially and in the CONVERGE trial. It is considered equivalent to the EPi-Sense ST.
Cannula with Guide (CSK-6131)
Potential complications
Probability of occurrence 30 days
Blunt trauma to adjacent organs
<1%a
Infection
<0.1%, less than 1 in 1,000 patientsb
Pericardial effusion
3.9%c
Vessel injury
<0.1%, less than 1 in 1,000 patientsa
Tissue perforation
0.2%a
Hemodynamic instabilities
<0.1%, less than 1 in 1,000 patientsb
Arrhythmias
<0.1%, less than 1 in 1,000 patientsb
Thromboembolic complication
2%d
Hernia
1.5%a,e
Pneumothorax
<0.1%, less than 1 in 1,000 patientsf
Conversion to Sternotomy
<0.1%, less than 1 in 1,000 patientsb
a Based on systematic literature review results for Cannula used with EPi-Sense Coagulation
System.
b Estimated rate based on complaints/commercial rate. These data may be underreported.
c Occurrence rate of pericardial effusions with tamponade physiology from CONVERGE trial:
3.9% (4/102).
d Occurrence rate from CONVERGE clinical trial: 1% (n=1/102) stroke; 1% (n=1/102) transient
ischemic attack
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
e The incidence of incisional hernias has been associated with trans-diaphragmatic pericardial access; sub-xiphoid access is more commonly used in contemporary best practice. f Pneumothorax not reported in post-market surveillance data, CONVERGE trial, or literature but remains a potential risk.
4.2 Warnings and precautions
EPi-Sense Coagulation Device
Warnings
· Care should be taken to ensure that the device is not in contact with tissue that is not going to be coagulated (e.g. vascular and nerve tissue), in order to avoid inadvertent tissue damage.
· To avoid unintentional coagulation, always ensure the device or device combined with optional guidewire is oriented toward the desired coagulation location.
· Avoid contact with other surgical instruments, scopes, staples, or other objects while coagulating. Inadvertent contact with objects while coagulating could lead to conduction of RF energy or heat and unintentional coagulation of tissues in contact with those objects.
· The device is provided sterile and is intended for single patient use only. Do not reprocess or reuse. Reuse can cause damage to device, patient injury, and/or the communication of infectious disease(s) from one patient to another.
· Do not scrape or scratch off the gold surface of the sensing electrodes when cleaning the RF coagulation electrode to avoid an adverse reaction due to copper exposure to the patient.
· Inspect all devices and packaging prior to use. If any breach of the packaging is found the sterility of the product cannot be ensured which poses a risk of patient injury. Do not use product if breach is found.
· The risk of igniting flammable gases or other materials is inherent in the application of RF energy. Precautions must be taken to restrict flammable materials from the area where tissue coagulation is performed.
· Care should be taken to ensure device is not moved during RF power delivery. Device movement may cause loss of suction and tissue tear and/or unintentional ablation.
· Care should be taken to ensure no vessels (or other structures) are restricted during device manipulation. Vessel restriction could cause hemodynamic instabilities or patient harm.
· Care should be taken to confirm device placement before power application to avoid collateral tissue damage.
· Care should be taken to fill distal end of cannula within the pericardial space with room temperature saline during ablation to avoid collateral tissue damage.
· Care should be taken to ensure device is perfused during ablation to avoid unintentional tissue damage.
· Physicians should implement a comprehensive anti-coagulation protocol including preoperative, intra-operative and post-operative anti-coagulation management to prevent potential thromboemboli.
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CEM-265 Rev D
· Physicians should use esophageal temperature monitoring as was conducted during the clinical investigation of the device to monitor for potential collateral tissue damage. Throughout the procedure ensure the probe is located directly behind the ablation probe to ensure an accurate reading.
· Physicians should consider post-operative anti-inflammatory medication to decrease the potential for post-operative pericarditis and/or delayed post-procedure inflammatory pericardial effusions.
· The coagulation device utilizes preset power and time settings; adjustment of these settings may result in excess or inadequate energy transmission.
· Physicians should consider post-operative proton pump inhibitors (PPIs) to decrease the potential for post-operative esophageal irritations.
· When inserting or retracting cannula from body, ablation device and standard 0.035 in (0.89 mm) guidewire should NOT be extended beyond tip of cannula.
· Excessive flexing and/or improper manipulation of the EPi-Sense with surgical tools can result in damage to the device.
· Ensure overlapping structures are separated and thermally isolated when anatomy allows. If the overlapping structures cannot be separated, ablation should not be performed.
· Reuse of the ground pad utilized in the epicardial portion of the procedure for the endocardial portion may result in patient harm.
· Simultaneous epicardial and endocardial mapping or ablation may result in cardiac injury.
· To avoid patient harm, care should be taken to assure the ablation electrode is oriented towards the heart and away from the pericardium using visual cues, i.e. Reference Dots, Locator Arrows, and black stripe.
· The coil on the distal end of the device must be kept clean of coagulum during surgery to avoid loss of power. Do not clean coagulum off the electrode of the device with an abrasive cleaner or electrosurgical tip cleaner. The electrodes could be damaged resulting in device failure.
· Implantable cardioverter/defibrillators can be adversely affected by RF signals.
· The use and proper placement of an Indifferent Electrode is a key element in the safe and effective use of electrosurgery, particularly in the prevention of patient burns. Ensure entire area of electrode is reliably attached to the patient's body.
· While the distal portion of the device is designed to be malleable to conform to the anatomy of the area to be ablated, excessive manipulation, torquing, rough shaping, or forcing the movement of the device may damage or deform the distal end and cause potential patient harm. This may also cause the sensing electrodes to become detached and or break off the device.
· Care should be taken when handling the distal end of the device near the electrode with surgical instruments to prevent fragments from breaking off of the device do not squeeze or clamp the electrode. Do not cut or tear silicone.
· The coagulation device is only suitable for use with the compatible AtriCure RF generator, cables, and accessories. Use of another manufacturer's accessories may cause damage to the device and/or injury to the patient.
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CEM-265 Rev D
· Care should be taken to ensure the path to position the device is large enough to advance the device easily forcing the device may damage the device, cause tissue damage or patient harm.
· Care should be taken to ensure device is not twisted or over manipulated during procedure. Twisting/torquing/over manipulating device can cause damage to the device, the lumen to collapse, fracture of electrodes or vacuum lumen spring, separation of electrodes from device, kinking of PEEK guide tube, loss of suction, disconnection of perfusion/IV tubing, kinked perfusion/IV tubing, or patient harm.
· Connection of multiple devices to one vacuum unit may reduce vacuum functionality.
· Care should be taken to ensure optional guidewire stays in the sterile field during manipulation to prevent infection.
· Care should be taken to visualize the devices and/or guidewire components when in the body, during introduction and/or removal from the Cannula. Always fully retract devices and components prior to insertion and removal in order to avoid inadvertent tissue damage with the devices and or guidewire.
· Before ablation of tissue, ensure guidewire and/or scope are not between tissue and coagulation device electrode to avoid ablation of unintended tissue.
· If a guidewire is used with coagulation device, ensure that insulative covering is intact along the exposed Guidewire to prevent ablation of unintended tissue.
· The coagulation devices should be used by physicians trained in the techniques of minimally invasive endoscopic surgical procedures and in the specific approach to be used to prevent patient harm.
· If using a TEE probe, care should be taken to withdraw the TEE probe prior to ablation to avoid compressing the esophagus against the left atrium during ablation.
· If the coagulation device is used near a pacemaker/AICD, a potential hazard exists due to possible interference with the action of the pacemaker and potential damage to the pacemaker. Consider placing a magnet on the pacemaker/AICD or programming the pacemaker/AICD per the manufacturer's instructions for use before applying RF energy.
· Physicians should obtain post-procedural imaging (i.e. 1-3 weeks post-procedure) for detection of post-procedure inflammatory pericardial effusions.
· This device contains small amounts of Nickel (CAS# 7440-02-0) and Cobalt (CAS# 7440-48-4). Do not use the device if the patient has sensitivity to Nickel or Cobalt as this may result in an adverse patient reaction.
· Additional warnings and precautions can be found in the compatible AtriCure RF Generator Operators Manual. Failure to follow the instructions contained in the RF generator manual may lead to an inability to complete the procedure.
· Using excess force to remove the device from the tray may result in damage to the device.
· Do not set vacuum to pressures outside of -375 to -425 mmHg (-7.25 to -8.22 psi; 50.0 to -56.7 kPa) - deviating from this pressure range may reduce suction capabilities, reduce tissue contact, or cause tissue damage
· Verify that IV line is fully open. Do not pressurize saline bag; that is, do not use an infusion pump for delivery or a pressure bag. Pressurizing saline or partially open
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perfusion tubing can vary perfusion rate causing loss of suction and the coagulation dimensions to vary from values listed, and cause tissue perforations from excess heating.
· Ensure device is primed prior to first RF power delivery to prevent unintended tissue damage.
· Use ONLY 0.9% normal saline to prevent unintended tissue damage.
· Ensure perfusion/IV tubing is connected to the handle at the "droplet" symbol to avoid unintended tissue damage do not connect perfusion tubing to stopcock or "Guide Wire Exit".
· Ensure arrows on cable and handle are aligned and cable is completely connected. Device will not register on generator if cable is incorrectly connected.
· Ensure inputs from the ECG recorder are isolated from earth ground, if not, there is an increased possibility of fibrillation.
· Esophageal temperature monitoring should be utilized during epicardial and endocardial ablation to prevent damage to the esophagus. If esophageal temperature increases more than 0.5 ºC (0.9 ºF) during each ablation or above an absolute maximum of 38.0 ºC (100.4 ºF), RF energy should be terminated until temperature reduces to baseline or under 37 ºC (98.6 ºF).
· Care should be taken to ensure lesions overlap in order to achieve exit block.
· Ensure that fluid in pericardial space is aspirated during manipulation. Failure to do so may compromise visibility and device placement, leading to patient harm.
· The EPi-Sense Coagulation Device has a limited functional life; if greater than 30 ablation cycles are completed and additional ablations cannot be performed, replace device.
· Ensure device is disposed of following local governing ordinances and recycling plans to prevent biohazard exposure.
· To avoid interruption of vacuum or perfusion flow, do not leave device tubing clamped during coagulation of tissue.
· Large blood clots and tissue particles may clog vacuum lumen and impair suction.
· To avoid tissue or device damage: Do not move the device if vacuum is engaged.
· Do not torque coagulation device if distal end is curved as damage to device may occur and the electrodes may separate and/or break off from the device.
· Visualize the distal end of the device, to ensure it is not pinching/entrapping tissue with other devices, such as the Cannula.
· Care should be taken when handling the distal end of the device near the electrode with surgical instruments do not squeeze or clamp the electrode. Do not use tools on the electrode coil, place tools on silicone only as the electrodes may separate and/or break off from the device.
· Temporarily unused active electrodes should be stored in a location isolated from the patient. Failure to do so may lead to patient burns
_____________________________________________________________________________
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Cautions
· Interference produced by the operation of high-frequency surgical equipment may adversely affect the operation of other electronic medical equipment such as monitors and imaging systems. Rearrange monitoring device cables so they do not overlap the Coagulation System cables.
· Coagulation devices have pre-set power and time settings for optimal ablation. Changing these settings may cause ablation dimension to vary from the values given in this document.
· Precautionary measures should be taken prior to considering treatment of patients:
· Deemed to be high risk and who may not tolerate a potential delayed postprocedure inflammatory pericardial effusion.
· Who may not be compliant with needed follow-ups to identify potential safety risks.
· To ensure patients undergoing treatment with the EPi-Sense device are well informed, the benefits, potential risks and procedural outcomes associated with the EPi-Sense Hybrid Convergent procedure should be discussed with the patient. Physicians should document accordingly in the medical record.
· Qualified operators are physicians authorized by their institution to perform surgical subxiphoid pericardial access.
· Operators should complete training on the use of EPi-Sense device before performing the procedure.
· Safety and effectiveness of concomitant left atrial appendage closure was not evaluated in the CONVERGE study.
· Cables to surgical electrodes should be positioned to prevent contact with patient or other leads
· Positioning and manipulation of the coagulation device without a guide wire inserted into the guide tube may cause the guide tube to kink. Avoid inserting guidewire into kinked guide tube.
· Ensure device is properly connected switching connections may cause inadequate tissue contact and reduced functionality.
EPi-Sense ST Coagulation Device
Warnings
· Physicians should consider post-operative anti-inflammatory medication to decrease the potential for post-operative pericarditis and/or delayed post-procedure inflammatory pericardial effusions.
· Physicians should obtain post-procedural imaging (i.e. 1-3 weeks post-procedure) for detection of post-procedure inflammatory pericardial effusions.
· The coagulation device utilizes preset power and time settings; adjustment of these settings may result in excess or inadequate energy transmission.
· Physicians should consider post-operative proton pump inhibitors (PPIs) to decrease the potential for post-operative esophageal irritations.
· The EPi-Sense ST Coagulation Device should only be used under direct visualization. _____________________________________________________________________________
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Care should be taken to visualize the devices and/or guidewire components when in the body, during introduction and/or removal from the Cannula. Always fully retract devices and components prior to insertion and removal in order to avoid inadvertent tissue damage with the devices and or guidewire.
· When inserting or retracting Cannula from body, ablation device and standard 0.035 in (0.89 mm) guidewire should NOT be extended beyond tip of Cannula.
· Care should be taken to ensure the path to position the device is large enough to advance the device easily forcing the device may damage the device, cause tissue damage or patient harm.
· Excessive flexing and/or improper manipulation of the EPi-Sense ST Coagulation Device with surgical tools can result in damage to the device.
· Care should be taken to ensure that the device is not in contact with tissue that is not going to be ablated (e.g. vascular and nerve tissue), in order to avoid inadvertent tissue damage.
· To avoid unintentional ablation, always ensure the device or device combined with optional guidewire is oriented toward the desired ablation location.
· Avoid contact with other surgical instruments, scopes, staples, or other objects while coagulating. Inadvertent contact with objects while coagulating could lead to conduction of RF energy or heat and unintentional ablation of tissues in contact with those objects.
· The device is provided sterile and is intended for single patient use only. Do not reprocess or reuse. Reuse can cause damage to device, patient injury, and/or the communication of infectious disease(s) from one patient to another.
· Do not scrape or scratch off the gold surface of the sensing electrodes when cleaning the RF ablation electrode to avoid an adverse reaction due to copper exposure to the patient.
· Inspect all devices and packaging prior to use. If any breach of the packaging is found the sterility of the product cannot be ensured which poses a risk of patient injury. Do not use product if breach is found.
· The risk of igniting flammable gases or other materials is inherent in the application of RF energy. Precautions must be taken to restrict flammable materials from the area where tissue ablation is performed.
· Care should be taken to ensure device is not moved during RF power delivery. Device movement may cause loss of suction and tissue tear and/or unintentional ablation.
· Ensure overlapping structures are separated and thermally isolated when anatomy allows. If the overlapping structures cannot be separated and thermally isolated, ablation should not be performed.
· Care should be taken to ensure no vessels (or other structures) are restricted during device manipulation. Vessel restriction could cause hemodynamic instabilities or patient harm.
· Care should be taken to confirm device placement before power application to avoid collateral tissue damage.
· Physicians should implement a comprehensive anti-coagulation protocol including preoperative, intra-operative and post-operative anticoagulation management to prevent
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
potential thromboemboli.
· Physicians should use esophageal temperature monitoring as was conducted during the clinical investigation of the device to monitor for potential collateral tissue damage. Throughout the procedure ensure the probe is located directly behind the ablation probe to ensure an accurate reading.
· Reuse of the ground pad utilized in the epicardial portion of the procedure for the endocardial portion may result in patient harm.
· Simultaneous epicardial and endocardial mapping or ablation may result in cardiac injury.
· The coil on the distal end of the device must be kept clean of coagulum during surgery to avoid loss of power. Do not clean coagulum off the electrode of the device with an abrasive cleaner or electrosurgical tip cleaner. The electrodes could be damaged resulting in device failure.
· Implantable cardioverter/defibrillators can be adversely affected by RF signals.
· The use and proper placement of an Indifferent Electrode a key element in the safe and effective use of electrosurgery, particularly in the prevention of patient burns. Ensure entire area of electrode is reliably attached to the patient's body.
· While the distal portion of the device is designed to conform to the anatomy of the area to be ablated, excessive manipulation, torquing, rough shaping, or forcing the movement of the device may damage or deform the distal end and cause potential patient harm. This may also cause the sensing electrodes to become detached and or break off the device.
· Care should be taken when handling the distal end of the device near the electrode with surgical instruments to prevent fragments from breaking off of the device do not squeeze or clamp the electrode. Do not cut or tear silicone.
· The coagulation device is only suitable for use with the compatible AtriCure RF generator, cables, and accessories. Use of another manufacturer's accessories may cause damage to the device and/or injury to the patient.
· Care should be taken to ensure device is not twisted or over manipulated during procedure. Twisting/torquing/over manipulating device can cause damage to the device, the lumen to collapse, fracture of electrodes or vacuum lumen spring, separation of electrodes from device, kinking of PEEK guide tube, loss of suction, disconnection of perfusion/IV tubing, kinked perfusion/IV tubing, or patient harm.
· To avoid patient harm, care should be taken to assure the ablation electrode is oriented towards the heart and away from the pericardium using visual cues, i.e., Reference Dots, Locator Arrows, and white stripe.
· Connection of multiple devices to one vacuum unit may reduce vacuum functionality.
· Care should be taken to ensure optional guidewire stays in the sterile field during manipulation to prevent infection.
· Before ablation of tissue, ensure guidewire and/or scope are not between tissue and ablation device electrode to avoid ablation of unintended tissue.
· If a guidewire is used with coagulation device, ensure that insulative covering is intact along the exposed guidewire to prevent ablation of unintended tissue.
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Form-522.A
AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
· The coagulation device should be used by physicians trained in the techniques of minimally invasive endoscopic surgical procedures and in the specific approach to be used to prevent patient harm.
· If using a TEE probe, care should be taken to withdraw the TEE probe prior to ablation to avoid compressing the esophagus against the left atrium during ablation.
· If the coagulation device is used near a pacemaker/AICD, a potential hazard exists due to possible interference with the action of the pacemaker and potential damage to the pacemaker. Consider placing a magnet on the pacemaker/AICD or programming the pacemaker/AICD per the manufacturer's instructions for use before applying RF energy.
· Low battery will trigger the indicator light on the handle to Yellow and stop the application of RF energy. Reference troubleshooting table in IFU.
· High temperature of distal pod will trigger the indicator light on the handle to Red and stop the application of RF energy. Reference troubleshooting table in IFU.
· This device contains small amounts of Nickel (CAS# 7440-02-0) and Cobalt (CAS #7440-48-4). Do not use the device if the patient has sensitivity to Nickel or Cobalt as this may result in an adverse patient reaction.
· Additional warnings and precautions can be found in the compatible AtriCure RF Generator Operators Manual. Failure to follow the instructions contained in the RF generator manual may lead to an inability to complete the procedure.
· Using excess force to remove the device from the tray may result in damage to the device.
· Do not set vacuum to pressures outside of -375 to -425 mmHg (-7.25 to -8.22 psi; 50.0 to -56.7 kPa) deviating from this pressure range may reduce suction capabilities, reduce tissue contact, or cause tissue damage.
· Verify that IV line is fully open. Do not pressurize saline bag; that is, do not use an infusion pump for delivery or a pressure bag. Pressurizing saline or partially open perfusion tubing can vary perfusion rate causing loss of suction and the ablation dimensions to vary from values listed, and cause tissue perforations from excess heating.
· Ensure perfusion/IV tubing is connected to perfusion tubing with luer connector (IRRIG) to avoid unintended tissue damage do not connect perfusion tubing to stopcock or "Guidewire Port."
· Ensure arrows on cable and handle are aligned and cable is completely connected. Device will not register on generator if cable is incorrectly connected.
· Ensure inputs from the ECG recorder are isolated from earth ground, if not, there is an increased possibility of fibrillation.
· Ensure that fluid in pericardial space is aspirated during manipulation. Failure to do so may compromise visibility and device placement, leading to patient harm.
· The EPi-Sense ST Coagulation Device has a limited functional life; if greater than 30 ablation cycles are completed and additional ablations cannot be performed, replace device.
· Ensure device is disposed of following local governing ordinances and recycling plans to prevent biohazard exposure.
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Form-522.A
AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
· To avoid interruption of vacuum or perfusion flow, do not leave device tubing clamped during coagulation of tissue.
· Large blood clots and tissue particles may clog vacuum lumen and impair suction.
· To avoid tissue or device damage: Do not move the device if vacuum is engaged.
· Do not torque coagulation device if distal end is deflected as damage to device may occur and the electrodes may separate and/or break off from the device.
· Visualize the distal end of the device, to ensure it is not pinching/entrapping tissue with other devices, such as the Cannula.
· Care should be taken when handling the distal end of the device near the electrode with surgical instruments do not squeeze or clamp the electrode. Do not use tools on the electrode coil, place tools on silicone only as the electrodes may separate and/or break off from the device.
· Temporarily unused active electrodes should be stored in a location isolated from the patient. Failure to do so may lead to patient burns.
· Esophageal temperature monitoring should be utilized during epicardial and endocardial ablation to prevent damage to the esophagus. If esophageal temperature increases more than 0.5 ºC (0.9 ºF) during each ablation or above an absolute maximum of 38.0 ºC (100.4 ºF), RF energy should be terminated until temperature reduces to baseline or under 37 ºC (98.6 ºF).
· Care should be taken to ensure lesions overlap in order to achieve exit block.
· Esophageal temperature monitoring should be utilized during endocardial ablation to prevent damage to the esophagus. If esophageal temperature increases more than 0.5 ºC (0.9 ºF) during each ablation or above an absolute maximum of 38.0 ºC (100.4 ºF), RF energy should be terminated until temperature reduces to baseline or under 37 ºC (98.6 ºF).
Cautions
· Care should be taken to fill distal end of Cannula within the pericardial space with room temperature saline during ablation to avoid collateral tissue damage.
· Care should be taken to ensure device is perfused during ablation to avoid unintentional tissue damage.
· Precautionary measures should be taken prior to considering treatment of patients:
· Deemed to be high risk and who may not tolerate a potential delayed postprocedure inflammatory pericardial effusion.
· Who may not be compliant with needed follow-ups to identify potential safety risks.
· To ensure patients undergoing treatment with the EPi-Sense ST Coagulation Device are well informed, the benefits, potential risks and procedural outcomes associated with the EPi-Sense ST Coagulation Device Hybrid Convergent procedure should be discussed with the patient. Physicians should document accordingly in the medical record.
· Qualified operators are physicians authorized by their institution to perform surgical
subxiphoid pericardial access.
_____________________________________________________________________________
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Form-522.A
AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
· Operators should complete training on the use of EPi-Sense ST Coagulation Device before performing the procedure.
· Interference produced by the operation of high-frequency surgical equipment may adversely affect the operation of other electronic medical equipment such as monitors and imaging systems. Rearrange monitoring device cables so they do not overlap the Coagulation System cables.
· Coagulation devices have pre-set power and time settings for optimal ablation. Changing these settings may cause ablation dimension to vary from the values given in this document.
· Safety and effectiveness of concomitant left atrial appendage closure was not evaluated in the CONVERGE study.
· Ensure device is primed prior to first RF power delivery.
· Use ONLY 0.9% normal saline.
· Cables to surgical electrodes should be positioned to prevent contact with patient or other leads.
· Ensure device is properly connected switching connections may cause inadequate tissue contact and reduced functionality.
· Positioning and manipulation of the coagulation device without a guide wire inserted into the guide tube may cause the guide tube to kink. Avoid inserting guidewire into a kinked guide tube.
Cannula with Guide
Warnings
· The Cannula is provided sterile and is intended for single use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another.
· Inspect the device packaging prior to use. If any breach of the packaging is found, the sterility of the product cannot be assured, and the product should not be used
· Inspect the Cannula and guidewire prior to use. Ensure Cannula distal end and guidewire are smooth with no sharp edges. Sharp edge can cause potential patient harm. If sharp edge is found, device should not be used.
· Care should be taken when inserting or removing the Cannula with Guide. Applying excess force could cause potential patient harm. To reduce friction during insertion, lubricate the Cannula with sterile saline.
· Care should be taken when manipulating the Cannula or guidewire. Always ensure no tissue is caught by the guidewire and brought into the Cannula with Guide lumen as this may cause altered hemodynamics or unintended tissue damage.
· Care should be taken when manipulating the guidewire, scope, and any over-the-wire devices. Excessive forces may damage the Cannula and/or guidewire or cause unintended tissue damage. The Cannula with Guide has a limited functional life; if greater than 18 bend cycles of the Cannula, guidewire, or scope are intended, it is recommended to monitor for damage. If damage is observed, replace the device.
· Avoid excessive pulling on the torquer. Excessive pulling on torquer may damage the _____________________________________________________________________________
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Form-522.A
AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Cannula and/or guidewire or cause patient injury.
· This device contains small amounts of Nickel (CAS# 7440-02-0). Do not use the device if the patient has sensitivity to Nickel as this may result in an adverse patient reaction.
· When removing Cannula from packaging, care should be taken to ensure guidewire, Cannula cap, and stopcock remain inside sterile field to reduce risk of infection.
· Insertion or removal of the Cannula with Guide while guidewire is extended may cause potential patient harm. Always fully retract the guidewire into the Cannula with Guide lumen.
· Cannula cap and torquer should be removed prior to insertion and removal of any overthe-wire devices failure to remove cap prior to insertion may result in damage to the Cannula cap and/or the over-the-wire devices preventing application of the intended therapy.
· Do not modify Cannula modification could produce sharp edges resulting in unintended tissue damage.
· Care should be taken when handling surgical instruments near the distal end of the Cannula do not clamp the distal end of the guidewire with surgical instruments or allow surgical instruments to stay outside the Cannula lumen during manipulation. Doing so may cut or break Cannula and cause tissue perforation or unintended damage.
· Ensure device is disposed of following local governing ordinances and recycling plans to prevent biohazard exposure.
Precautions
· Avoid over-rotating the Cannula with Guide. Over-rotation can cause the vacuum tubing of the Cannula to kink, reducing the Cannula suction, thus causing reduced visibility.
· Avoid over-inserting the Cannula with Guide into patient body. Over insertion may reduce Cannula suction.
· Inspect the device prior to use. If any damage is found, the function of the product cannot be assured, and the product should not be used.
Cautions
· Failure to place guidewire through hole in center of cap (puncturing cap or placing outside cap entirely) may reduce cap functionality.
· Failure to replace torquer exposes the sharp proximal end of the guidewire and may cause injury to patient and/or user.
· Ensure Cannula cap is fully attached to the Cannula grip failure to fully attach cap my reduce functionality of the Cannula cap.
· Do not manipulate Cannula by grasping the tab of the Cannula cap. Doing so may loosen or remove Cannula cap from Cannula causing reduced functionality.
· Do not set vacuum pressure outside the range of -225 to -275 mmHg (-4.35 to -5.32 psi; -30.0 to -36.7 kPa).
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Form-522.A
AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
· Large blood clots and tissue particles may clog vacuum lumen and impair suction to Cannula with Guide.
· To avoid interruption of vacuum or perfusion flow, ensure tubing is not clamped or kinked during coagulation of tissue.
4.3 Other relevant aspects of safety, including a summary of any field safety corrective action (FSCA including FSN) if applicable
The field action 3011706110-05.18.19-005-R was conducted. The sterile package seal for the EPi-Sense Coagulation System (CDK-1413) was potentially compromised and had a worst-case reasonable harm of an infection. A Field Safety Notice was issued for a recall of affected lots in the US, Netherlands, and Germany on 29 May 2019. All actions have been conducted to close the field action. The recall was terminated on 04 May 2020.
5. Summary of clinical evaluation and post-market clinical follow-up (PMCF)
This section is intended to summarise, in a comprehensive manner, the clinical evaluation results and the clinical data forming the clinical evidence for the confirmation of conformity with relevant general safety and performance requirements, the evaluation of undesirable side-effects and the acceptability of the benefit-risk ratio. It shall be an objective and balanced summary of the clinical evaluation results of all the available clinical data related to the device in question, whether favourable, unfavourable, and/or inconclusive.
5.1 Summary of clinical data related to equivalent device, if applicable
The EPi-Sense ST Coagulation Device (EPiST) was assessed and endorsed by the Notified
Body on the basis of equivalence. Equivalence was demonstrated to the EPi-Sense
Coagulation
Device
(CDK-1413;
AtriCure,
Inc.;
Basic
UDI-DI:
08401439000000000000010ZC). The EPi-Sense Coagulation Device and clinical data to
support its safety and performance are included in this SSCP.
The Cannula with Guide (CSK-6131) was assessed and endorsed by the Notified Body on the basis of equivalence. Equivalence was demonstrated to the predicate design of the Cannula with Guide (AtriCure, Inc.) which was used in the CONVERGE trial and other observation studies. The Cannula with Guide and the clinical data to support its safety and performance are included in this SSCP.
5.2 Summary of clinical data from conducted investigations of the device before the CEmarking, if applicable
Identity of the
CONVERGE Trial
investigation/study
Clinicaltrials.gov: NCT01984346 DeLurgio et al. 20201
Identity of the device
EPi-Sense Coagulation Device (CDK-1413)
Cannula with Guide (CSK-6130)
AtriCure RF Generator System (CSK-310)
Sterile RF Cable (CSK-2000)
Intended use of the device Treatment of symptomatic persistent atrial fibrillation that is
in the investigation
refractory or intolerant to at least one class I and/or III
antiarrhythmic drug (AAD) when used with an open irrigated
RF ablation catheter to complete pulmonary vein (PV)
isolation by ablating breakthroughs between the epicardial
lesions.
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Objectives of the study
Study design and duration of follow-up Primary and secondary endpoint(s)
To demonstrate superiority of the convergent procedure (experimental) compared to the standalone endocardial catheter ablation (control) on overall success, defined as freedom from AF/AFL/AT absent class I and III AADs except for a previously failed class I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit. The incidence rate of Major Adverse Events (MAEs) in the treatment arm will demonstrate an acceptable risk profile.
Randomised controlled trial Primary endpoint follow-up: 12-months post-index procedure Long-term follow-up: 5-years post-index procedure
Primary effectiveness endpoint: Success or failure to be AF/AFL/AT free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit.
Primary safety endpoint: The primary safety endpoint for the study will be defined as the incidence of major adverse events (MAEs) listed below for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.
· Cardiac tamponade/perforation · Severe pulmonary stenosis · Excessive bleeding · Myocardial infarction · Stroke · Transient ischemic attack (TIA) · Atrioesophageal fistula · Phrenic nerve injury · Death
Secondary effectiveness endpoints:
· Success or failure to achieve a 90% reduction from baseline AF burden and off all class I and III AADs at 12 months post procedure
· Success or failure to achieve a 90% reduction from baseline AF burden regardless of their class I and III AAD status at 12 months post procedure
· Change in quality of life (QOL) measures at 12 months post procedure from baseline values
· Change in 6-minute walk test score from baseline score
· Success or failure to be AF free and off all class I and III AADs except a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit
· Success or failure to be AF free regardless of class I and III AAD status following the 3-month blanking
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
period through the 12-months post procedure followup visit
Inclusion/exclusion criteria for subject selection
Secondary safety endpoint: · Incidence of serious adverse events (SAEs) in the study through the 12-month post procedure visit, in each arm of the study.
Inclusion criteria: · Age > 18 years; < 80 years · Left atrium < 6.0 cm (Trans Thoracic Echo [TTE] parasternal 4 chamber view) · Refractory or intolerant to one AAD (class I and/or III) · Documentation of persistent AF · Provided written informed consent
Number of enrolled studies Study population
Exclusion criteria:
· Patients requiring concomitant surgery such as
valvular repair or replacement, coronary artery
bypass graft (CABG) surgery and atrial septal defect
closure.
· Left ventricular ejection fraction < 40%
· Pregnant or planning to become pregnant during
study
· Co-morbid medical conditions that limit one year life
expectancy
· Previous cardiac surgery
· History of pericarditis
· Previous cerebrovascular accident (CVA), excluding
fully resolved TIA
· Patients who have active infection or sepsis
· Patients with oesophageal ulcers strictures and
varices
· Patients with renal dysfunction who are not on
dialysis (defined as glomerular filtration rate [GFR]
40)
· Patients who are contraindicated for anticoagulants
such as heparin and coumadin
· Patients who are being treated for ventricular
arrhythmias
· Patients who have had a previous left atrial catheter
ablation for AF (does not include ablation for AFL or
other supraventricular arrhythmias)
· Patients with existing implantable cardioverter
defibrillators (ICDs).
Hybrid convergent arm: 102 patients
Endocardial ablation arm (control): 51 patients
EPi-Sense
Catheter Ablation
(Hybrid Convergent Arm)
(Endocardial
Ablation Arm)
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Age (years), Mean ± SD
63.7 ± 9.64
65.1 ± 6.66
Male
78% (80/102)
53% (27/51)
Caucasian
94% (96/102)
98% (50/51)
Height (cm), Mean ± SD
177.7 ± 8.43
173.9 ± 11.64
Weight (kg), Mean ± SD
Body mass index (kg/m2), Mean ± SD Number of years in atrial fibrillation (years since persistent AF diagnosis)
Persistent AF
104.3 ± 19.98 33.0 ± 5.86 4.4 ± 4.8
63% (64/102)
106.3 ± 23.90 35.1 ± 7.13 4.5 ± 4.7 47% (24/51)
Longstanding Persistent AF
37% (38/102)
53% (27/51)
Summary of study methods
This was a prospective, open-label, 2:1 randomized, multicentre, pivotal clinical study. Subjects were randomized to one of two procedures: convergent procedure utilizing the EPi-Sense or standalone endocardial catheter ablation procedure. Subjects with symptomatic persistent AF meeting all inclusion/exclusion criteria were eligible for this study. Subjects in both arms of the study were evaluated postprocedure at 1-, 3-, 6-, and 12-months. Subject participation in this study was 12-months from the procedure with additional, long-term follow-up visits at: 18-months, 2-, 3-, 4and 5-years post-procedure.
Summary of results
Safety and Effectiveness Endpoints All Patients
Endpoint
EPi-Sense
Catheter Ablation
Treatment Difference, p-value
Primary Effectiveness
65.7% (67/102)
49.0% (25/51)
16.7%
[95% CI: 56.5%, [95% CI: 35.3%,
[95% CI: 0.1%,
74.9%]
62.7%]
33.2%], p=0.0472
Primary Safety
7.84% (8/102)
-
-
[95% UCL: 13.7%]
Achieved 90% Burden
80.0% (60/75)
56.8% (25/44)
23.2%
Reduction at 12 Months, [95% CI: 70.9
[95% CI: 42.2
[95% CI: 6.0%,
without New/Increased
89.1%]
71.5%]
40.4%], p=0.0069
Class I/III AADs
AF Free at 12 Months,
70.6% (72/102)
51.0% (26/51)
19.6%
without New/Increased [95% CI: 61.7
[95% CI: 37.3
[95% CI: 3.3%,
Class I/III AADs
79.4%]
64.7%]
35.9%], p=0.0172
Change in AFSS
60, -11.7 ± 7.71
37, -10.3 ± 7.16
-
Composite Score at 12
Months: n, Mean ± SD
Change in SF-36
97, 7.3 ± 10.67
50, 5.7 ± 10.49
-
Physical Health
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Composite Score at 12
Months: n, Mean ± SD
Change in SF-36 Mental 97, 5.7 ± 10.51
50, 7.7 ± 12.78
-
Health Composite Score
at 12 Months: n, Mean ±
SD
Change in 6-Minute
94, 9.2 ± 120.59 48, -12.4 ± 190.09
-
Walk Score at 12
Months: n, Mean ± SD
Secondary Safety
32.4% (33/102)
35.3% (18/51)
-
Post-hoc Additional Effectiveness Endpoints All Patients*
Endpoint
EPi-Sense
Catheter Ablation
Treatment Difference
Freedom from
52.0% (53/102)
31.4 (16/51)
20.6%
Arrhythmia off AADs (12
(4.6 36.6%)
Months)
Freedom from
74.5% (76/102)
58.8% (30/51)
15.7%
Arrhythmia Regardless
(-0.25 31.6%)
of AADs (12 Months)
Freedom from
43.1% (44/102)
23.5% (12/51)
19.6%
Arrhythmia off AADs (18
(4.5 34.7%)
Months)
Freedom from
63.7% (65/102)
47.1% (24/51)
16.7%
Arrhythmia Regardless
(0.0 33.2%)
of AADs (18 Months)
Post-hoc Effectiveness and Safety Endpoints Longstanding Persistent AF*
Endpoint
EPi-Sense
Catheter Ablation
Treatment Difference
Primary Effectiveness
65.8% (25/38)
37.0% (10/27)
28.8%
[95% CI: 50.7 -
[95% CI: 18.8 -
[95% CI: 5.1 -
80.9%]
55.3%]
52.4%]
Primary Safety
7.9% (3/38) [19.2%
-
-
UCL]
Achieved 90% Burden
78.9% (30/38)
46.2% (12/26)
-
Reduction at 12 Months, [95% CI: 66.0
[95% CI: 27.0
without New/Increased
91.9%]
65.3%]
Class I/III AADs
AF Free at 12 Months,
71.1% (27/38)
37.0% (10/27)
-
without New/Increased
[95% CI: 56.6
[95% CI: 18.8
Class I/III AADs
85.5%]
55.3%]
Change in AFSS
23, -12.9 ± 7.79
22, -9.8 ± 7.93
-
Composite Score at 12
Months: n, Mean ± SD
Change in SF-36
38, 7.9 ± 9.27
27, 3.0 ± 10.40
-
Physical Health
Composite Score at 12
Months: n, Mean ± SD
Change in SF-36 Mental 38, 5.6 ± 13.49
27, 6.5 ± 14.61
-
Health Composite Score
at 12 Months: n, Mean ±
SD
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SSCP: AtriCure EPi-Sense Coagulation System
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Freedom from
52.6% (20/38)
25.9% (7/27)
26.7%
Arrhythmia off AADs (12
[95% CI 3.8
Months)
49.6%]
Freedom from
73.7% (28/38)
44.4% (12/27)
29.2%
Arrhythmia Regardless
[95% CI: 5.8
of AADs (12 Months)
52.6%]
Freedom from
47.4% (18/38)
22.2% (6/27)
25.2%
Arrhythmia off AADs (18
[95% CI: 2.8
Months)
47.5%]
Freedom from
68.4% (26/38)
33.3% (9/27)
35.1%
Arrhythmia Regardless
[95% CI: 12.0
of AADs (18 Months)
58.2%]
Secondary Safety
26.3% (10/38)
33.3% (9/27)
-
Study Limitations
· Absence of empirical endocardial posterior wall ablation
in catheter arm, though there are challenges with
obtaining safe transmural posterior wall ablation.
· Cryoballoon was not included for endocardial ablation.
· Electrical isolation/exclusion of left atrial appendage not
performed.
Any device deficiency or There were two (2) device malfunctions. In both cases, the
device replacements
impedance was too high, and the devices were replaced.
related to safety or
performance during the
study
*Confidence intervals in post-hoc analyses not adjusted for multiplicity.
5.3 Summary of clinical data from other sources, if applicable
Systematic literature searches are performed as part of the Clinical Evaluation for the subject devices. From these searches, the following publications were identified that reported clinical data from use of the EPi-Sense Coagulation Device and Cannula with Guide2-8. Additional clinical data have been published on the Cannula using earlier generations of the coagulation device; these studies are listed in the bibliography9-24.
Study, design, N Larson et al. 20202
Prospective, single centre
N=113
Performance outcomes
Survival free from any AF/AT episode > 30 seconds at 12months after the blanking period: 53%.
At one-year post-blanking, 94% of the cohort was free from an arrhythmia burden > 5%.
Safety outcomes
Total procedural complications were 16/113 (14%).
MAEs were reported for 5/113 patients (4.4%): 3 cardiac tamponade 2 excessive bleedings
Mean AF burden among the cohort at 12 months was 2.8%.
Procedural complications decreased significantly following the transition from trans-diaphragmatic to subxiphoid surgical access (23% vs. 3.8%; p=0.005).
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Study, design, N Performance outcomes Maclean et al. 20203 Hybrid versus endocardial:
Safety outcomes Hybrid versus endocardial:
Retrospective,
AF-free at 1 year (single
propensity-matched, procedure, on AADs):
single centre
60.5% vs. 25.6%, p=0.002
N=43 treated with EPi-Sense/Cannula in hybrid procedure; N=43 treated with endocardial catheter ablation only
AF-free at 1 year (single procedure, off AADs): 37.2% vs. 13.9%, p=0.025
Arrhythmia-free survival long term (multiple procedures, on AADs; mean follow-up 30.5 ± 13.3 months): 58.1% vs. 30.2%, p=0.036
Complications: 11.6% vs. 2.3%, p=0.2
MAEs were reported for 3/43 patients (6.98%): 2 cardiac tamponade 1 phrenic nerve injury
Arrhythmia-free survival long term (multiple procedures, off AADs; mean follow up 30.5 ± 13.3 months): 32.5% vs. 11.6%, p=0.82
Makati et al. 20204 Retrospective, registry analysis N=226
Ellis et al. 20205 Prospective, observational registry N=33
Freedom from AF/AFL/AT: 75% at Periprocedural complications:
15.4 ± 6.5 months follow-up
6%
Mean Residual AF Burden: 1.10% with 7.30 ± 3.00 months follow-up 8.5% with 19.05 ± 3.86 months follow-up
Proportion of patients with 5% AF burden: 94% at 7.30 ± 3.00 months followup 88% with 19.05 ± 3.86 months follow-up
Proportion of patients with 1% AF burden: 90% at 7.30 ± 3.00 months followup 80% with 19.05 ± 3.86 months follow-up Freedom from AF/AT: 91% (20 of 22 patients) at 6 months 90% (18 of 20 patients) at 12 months 92% (11 of 12 patients) at 18 months
There were five (5) additional pericardial effusions occurring 2-4 weeks post-procedure. These were managed medically or via pericardiocentesis with no long-term sequelae.
MAEs were reported for 6/226 patients (2.65%): 3 excessive bleeding 1 stroke 2 phrenic nerve injury
There were no (0) acute periprocedural complications (<7 days).
MAE rate was 0%.
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Study, design, N
Performance outcomes 92% (11 of 12) at 24 months
Safety outcomes
Thirty-day adverse events included two (2) patients with pericardial effusion requiring pericardiocentesis and one (1) incisional hernia repair.
Tonks et al. 20206
Retrospective, single centre
N=36
12-month freedom from atrial arrythmias was 78%.
There were no (0) long-term complications, strokes, or deaths. No (0) periprocedural deaths, re-operations, strokes, or major complications occurred.
One (1) patient had phrenic nerve palsy, two (2) patients had severe pericarditis, and three (3) patients had significant pericardial effusion.
Gulkarov et al. 20197
Retrospective, single centre
N=31
Free from AF/AFL at 1 year: 71% Free from AF at 1 year: 87% Free from AF/AFL at 2 years: 52% Free from AF at 2 years: 71%
MAEs were reported for 2/36 patients (5.56%): 1 cardiac tamponade 1 phrenic nerve injury There were four (4) periprocedural complications.
Two (2) patients suffered minor cerebrovascular accidents immediately after the procedure, which resolved over time without any residual deficit.
Two (2) patients developed pericardial effusion with cardiac tamponade that required emergent pericardial drainage about two (2) weeks after discharge.
Jan et al. 20188
Prospective, randomised
N=24 treated with EPi-Sense or
Free from AF/AT/AFL without AAD: 58.3% with Hybrid vs. 34.6% with catheter-only ablation group were free of AF/AT/AFL without AAD treatment during mean 30.5 ± 6.9 months follow-up.
MAEs were reported for 4/31 patients (12.90%): 2 cardiac tamponade 2 stroke Complication rates: Hybrid arm: 12.5% Catheter ablation arm: 0%
MAEs were reported for 1/24 patients (4.17%): 1 excessive bleeding
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Study, design, N
Numeris Coagulation Devicevi and Cannula in hybrid procedure N=26 treated with endocardial catheter ablation only
Performance outcomes
Recurrence of AF/AT/AFL was more likely in the catheter-only arm compared to the hybrid arm (OR 3.78 (95% CI (1.17, 12.19), p=0.048)).
Safety outcomes
5.4 An overall summary of the clinical performance and safety
The clinical benefits of the EPi-Sense and EPi-Sense ST Coagulation devices are to return to normal sinus rhythm (i.e., freedom from AF/AFL/AT), reduce AF symptoms (palpitations, shortness of breath at rest, shortness of breath during physical activity, exercise intolerance, fatigue at rest, lightheadedness/dizziness, and chest pain or pressure), and improve quality of life. The clinical benefit of the Cannula is to gain access to the pericardial space to permit epicardial ablation for the treatment of arrhythmias. Based on the Clinical Evaluation, these clinical benefits are supported by sufficient clinical data, including results from the CONVERGE trial and published clinical studies. The clinical evidence for EPi-Sense (CDK1413) applies to EPi-Sense ST (EPiST) based on equivalency.
The performance objective of the Clinical Evaluation was a pooled success rate (defined as return to normal sinus rhythm or freedom from AF/AFL/AT) at 12-months post-procedure of 65% with a lower confidence limit of 55%. The combined success rate from the CONVERGE trial and published literature identified in the Clinical Evaluation systematic literature review met this performance objective, with a pooled success rate of >65%.
The safety objective of the Clinical Evaluation was a major adverse event (MAE) rate of 12% with an upper confidence limit of 20%. Major adverse events include cardiac tamponade/perforation, severe pulmonary stenosis (70% reduction in diameter), excessive bleeding (requiring transfusion or 20% fall in hematocrit), myocardial infarction, stroke, transient ischemic attack, atrioesophageal fistula, phrenic nerve injury, and death. The combined MAE rate from the CONVERGE trial and published literature identified in the Clinical Evaluation systematic literature met this safety objective, with a pooled rate of <12%.
Based on the Clinical Evaluation, the benefits of the use of the subject devices outweigh the risks when the subject devices are used as intended, and the subject devices have a favourable risk-benefit ratio. The results from the clinical data did not identify any new or unexpected risks. Risk management activities have been performed and found the risk control measures in place continue to be effective, and all risks have been reduced as far as possible as required by AtriCure's risk management program and BS EN ISO 14971.
5.5 Ongoing or planned post-market clinical follow-up
AtriCure continues to follow long-term outcomes of the CONVERGE trial (described in Section 5.2). Patients are follow-up by phone at 2-, 3-, 4-, and 5-years post-convergent procedure. At each follow-up, data is collected on the patients' health status, rhythm status,
vi Jan et al. describes using a combination of EPi-Sense and Numeris Coagulation Devices to treat the cohort of patients. Numeris is a previous generation of the Coagulation Device that is not CEmarked under EU MDR. It is unknown how many patients were treated with the EPi-Sense Coagulation Device in this study. _____________________________________________________________________________
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CEM-265 Rev D
medication use (including class I and III AADs and anticoagulants), and adverse events.
There were no unanswered questions that emerged from the CONVERGE trial; however, AtriCure continues to collect data on the safety and performance of the EPi-Sense Coagulation System via post-market clinical follow-up (PMCF). Ongoing PMCF studies include investigator-sponsored research studies, the TRAC-AF registry (clinicaltrials.gov NCT05111015), and the CONVERGE post-approval study (CONVERGE PAS, clinicaltrials.gov NCT05393180).
Investigator-sponsored research using the EPi-Sense Coagulation System is (1) collecting additional real-world evidence on the use of the subject devices and procedures at the investigating center, (2) comparing outcomes from patients treated with the subject devices or procedures to outcomes from historical controls treated at the investigating center or in published literature, and (3) evaluating additional or new endpoints in patients treated with the subject devices or procedures.
TRAC-AF is a multicentre, retrospective/prospective registry that records outcomes from adult patients undergoing ablations for the treatment of AF. This includes outcomes from patients treated with the EPi-Sense Coagulation System. The goal of TRAC-AF is to improve the understanding of the efficacy of ablation interventions in the treatment of AF. This registry tracks outcomes related to AF recurrence, freedom from AF, AF burden, AAD use, adverse events, and procedure- or device-related complications.
CONVERGE PAS is a prospective, multicentre, open-label, single arm study to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense Coagulation System to treat symptomatic long-standing persistent atrial fibrillation patients who are refractory or intolerant to at least one class I and/or III AAD.
6. Possible diagnostic or therapeutic alternatives
Management of Atrial Fibrillation: Rate Control Rate control drugs, such as beta blockers, calcium channel blockers, and cardiac glycosides, can be used to slow the heart rate in atrial fibrillation. While these drugs do not cure AF, they may offer a lower side effect profile than rhythm control drugs. A recent meta-analysis, which included results from the AFFIRM clinical trial, found that rate and rhythm control drugs did not result in significantly different clinical outcomes, including mortality, bleeding, and thromboembolic rate, but that rhythm control drugs were associated with higher rehospitalization rates25.
Management of Atrial Fibrillation: Rhythm Control Currently, the main indications for rhythm control are for patients with paroxysmal or persistent atrial fibrillation who have hemodynamic compromise associated with episodes of atrial fibrillation or who have bothersome symptoms despite adequate rate control26. A rhythm control strategy involves initial pharmacologic or electronic cardioversion, followed by pharmacologic treatment to maintain normal sinus rhythm.
Management of Thromboembolic Events First-line management for stroke prevention is typically oral anticoagulation agents27. Traditional anticoagulants include heparins and coumarins (Vitamin K antagonists) of which warfarin is the most common28 in clinical use due to its proven efficacy.
A number of newer anticoagulant medications, including dabigatran, rivaroxaban, and apixaban29, have received U.S. Food and Drug Administration (FDA) approval for stroke prevention in nonvalvular AF and have demonstrated noninferiority to warfarin in clinical trials.
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CEM-265 Rev D
While oral anticoagulation medicine can be effective for stroke prevention, there is an increased risk of bleeding in patients as these types of medications prevent the blood from clotting. Additionally, many patients avoid this type of treatment because of adverse side effects and drug interaction.
Ablation Procedures Pharmaceutical options are solely limited to management of atrial fibrillation and/or risks associated with the condition; they are not treatment of the arrhythmia itself.
A variety of ablative procedures have been investigated as potentially curative approaches or perhaps modifying the arrhythmia such that drug therapy becomes more effective. Ablative approaches focus on interruption of the electrical pathways that contribute to atrial fibrillation, through modifying the triggers of atrial fibrillation and/or the myocardial substrate that maintains the aberrant rhythm30.
Understanding of the pathophysiological mechanism(s) underlying atrial fibrillation (AF) is the foundation on which current ablation strategies are built. A seminal finding in the 1990s was that the myocardial sleeves of the pulmonary veins (PVs) are a major site of AF triggers31. As a result, in most patients with paroxysmal AF, the ablation procedure should target the pulmonary veins32. In patients with non-paroxysmal AF, however, PV isolation alone seems to be insufficient to prevent the arrhythmia33,34. Over the years, using advanced mapping technologies, additional potential ablation targets outside of the PVs have been identified and tested, in particular for patients with persistent forms of AF. In addition to AF drivers, atrial substrate may be critical to sustained and progressive disease31. Substrate that may contribute to AF include atrial fibrosis, epicardial fat, and anatomical heterogeneity leading to endo/epicardial dissociation.
Lesions may be created via sequential incisions, or with use of a device that uses an energy source to burn or freeze the cardiac tissue. The most common types of energy for ablation include radiofrequency and cryothermal energy. These energy sources ablate the cardiac tissue by scarring or destroying the tissue to disrupt the electrical signals. Of these, RF energy is the one most commonly applied to ablate cardiac tissue that is determined to be the source of arrhythmia35,36. An emerging ablative method called pulsed field ablation (PFA), which involves irreversible electroporation of cells, is being explored as a cardiac ablation technique, but data is primarily preclinical37. PFA has the potential advantage of not carrying the risk of thermal injuries, but longer-term safety is currently unknown.
Surgical Ablation The Cox-Maze surgical ablation procedure was initially introduced in 1987. It involved complicated "maze" incisions to the atria as well as to the sinus node to disrupt erratic signals that interfered with normal sinus rhythm30. The Maze (`cut and sew') procedure, an open surgical procedure often combined with other cardiac surgeries (e.g., valve repair, coronary artery bypass grafting), is an ablative procedure involving sequential atriotomy incisions designed to create electrical barriers that prevent the maintenance of AF.
Contemporary Cox-Maze approaches employ radiofrequency or cryothermal energy in lieu of incisions to disrupt the electrical signal creates the arrythmia with similar lesion patterns, such as Cox-Maze III and Cox-Maze IV. Advantages of using cryoenergy to ablate the cardiac tissue include the preservation of collagen and maintenance of the structural integrity of the tissue38. Despite the advantages of using cryoablation probes, there are limitations or conditions which may impact the efficacy of this technology. Limitations on the efficacy of cryoablation include the thickness of the tissue being ablated; thick cardiac tissue may require multiple applications of the cryoprobe. _____________________________________________________________________________
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CEM-265 Rev D
Because of the highly invasive nature of open-heart surgical ablation, it is currently reserved mainly for patients who are undergoing open heart surgery for other reasons, such as valve repair or coronary artery bypass grafting. However, thoracoscopic approaches using RF ablation clamps or pens to create epicardial lesions to approximate the "maze" lesions have been described for use in patients who are not undergoing concomitant open cardiac surgery39,40. Additionally, hybrid techniques that combine minimally invasive epicardial ablation with endocardial ablation have also been described that can create the Cox-Maze IV41 or similar but reduced lesion sets.
Catheter Ablation Percutaneous catheter-based ablation is a well-established interventional approach for treating a variety of arrhythmias35, in which intracardiac mapping identifies a discrete arrhythmogenic focus that is the target of ablation. The situation is more complex for AF, since there is not a single arrhythmogenic focus and there may be additional drivers of AF that are sustaining rather than initating42. Since the inception of ablation techniques in the early 1990s, there has been a progressive understanding of the underlying electrical pathways in the heart that are associated with AF. In the late 1990s, it was recognized that AF most frequently arose from an abnormal focus at or near the junction of the pulmonary veins and the left atrium, leading to the feasibility of more focused, percutaneous ablation techniques. The basic strategies that have emerged for focal ablation within the pulmonary veins, as identified by electrophysiologic mapping, are segmental ostial ablation guided by pulmonary vein potential (electrical approach), or circumferential pulmonary vein ablation (anatomic approach). Circumferential pulmonary vein ablation currently is the most commonly used approach.
Catheter ablation procedure uses endocardial catheter-based techniques via a transvenous approach43. There has been some evolution in catheter-based technology over time, including improvements to irrigation to reduce volume load and steam pops, as well as real-time contact force-sensing between the catheter and cardiac tissue to potentially improve clinical outcomes. Despite such efforts to improve catheter ablation success, improved efficacy as assessed through randomized clinical trials, observational studies, and meta-analyses has not been consistently demonstrated44-47.
Several endocardial catheters are intra-cardiac electrophysiology diagnostic catheters; these devices enable the physician to monitor (i.e., by sensing, pacing, and recording) the success of the lesions in treating atrial fibrillation. High density mapping with circular catheters can help guide and optimize additional lesions, and may be useful to identify non-pulmonary vein targets48.
Minimally Invasive Devices More recently, minimally invasive devices to ablate cardiac tissue have been created. Aiming to preserve efficacy while reducing complication rates and recovery time, several minimally invasive surgical techniques have been described which vary in access site, ablation energy source, and lesion set49,50. These devices are introduced to the epicardial tissue via laparoscopic, thoracoscopic, and/or endoscopic procedures to create lesions of the cardiac tissue. These procedures involve small incisions (i.e., keyholes) to access the cardiac tissue. The devices that are the subject of this SSCP are minimally invasive devices which use RF energy to ablate the cardiac tissue resulting in the creation of lesions which interrupt the errant signals generated by the arrhythmia. For the subject devices in this SSCP, lesions are created to the beating heart under direct visualization from a guide wire.
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CEM-265 Rev D
7. Suggested profile and training for users
Cardiac and thoracic surgeons are qualified by training and education to use the AtriCure EPiSense, EPi-Sense ST, and Cannula devices. AtriCure offers additional comprehensive education and training on the use of these AtriCure devices per the device instructions for use. This training will be available to the clinicians using the AtriCure EPi-Sense, EPi-Sense ST, and Cannula devices.
8. Reference to any harmonized standards and CS applied
Standard
BS EN ISO 13485:2016+A11: 2021 Medical devices Quality management systems Requirements for regulatory purposes BS EN ISO 14971:2019 +A11:2021 Medical devices Application of risk management to medical devices BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects Good clinical practice BS EN ISO 10993-1:2020 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process BS EN ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood BS EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity BS EN ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization BS EN ISO 10993-11:2018 Biological evaluation of medical devices Part 11: Test for systemic toxicity BS EN ISO 10993-12:2021 Biological evaluation of medical devices Part 12: Sample Preparation and reference materials BS EN ISO 10993-23:2021 Biological evaluation of medical devices -- Part 23: Tests for irritation
BS EN 60601-1:2006+A2:2021 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Devices
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula EPi-Sense EPi-Sense ST Cannula EPi-Sense EPi-Sense ST Cannula EPi-Sense EPi-Sense ST Cannula
EPi-Sense EPi-Sense ST
Cannula EPi-Sense EPi-Sense ST
Compliance (full/partial/no)
Full
Full
Full
Full
Full
Full Full Full Full
Full Full
Rationale if partial/no
N/A
N/A
N/A
N/A
N/A
N/A N/A N/A N/A
N/A N/A
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CEM-265 Rev D
Standard
BS EN 60601-1-6:2010+A2:2021 Medical electrical equipment Part 16: General requirements for basic safety and essential performance -- Collateral standard: Usability BS EN 60601-1-2:2015+A1:2021 Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests BS EN 60601-2-2:2018 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories ISTA 3A:2018 Performance testing of Shipping Containers and Systems
BS EN ISO 11135:2014+A1+2019: Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices BS EN ISO 11137-1:2015+A2:2019 Sterilization of health care products. Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation Part 2: Establishing the sterilization dose BS EN ISO 11737-1:2018/A1:2021 Sterilization of health care products. Microbiological methods BS EN ISO 11737-2:2020: Sterilization of health care products. Microbiological methods BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems BS EN ISO 11607-2:2020 Packaging for terminally sterilized medical
Devices EPi-Sense EPi-Sense ST
EPi-Sense EPi-Sense ST
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula EPi-Sense ST
EPi-Sense Cannula
EPi-Sense Cannula
EPi-Sense EPi-Sense ST
Cannula EPi-Sense EPi-Sense ST Cannula EPi-Sense EPi-Sense ST Cannula
EPi-Sense EPi-Sense ST
Compliance (full/partial/no)
Full
Full
Full
Full Full
Full
Full Full Full Full
Full
Rationale if partial/no
N/A
N/A
N/A
N/A N/A
N/A
N/A N/A N/A N/A
N/A
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SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
Standard
devices - Part 2: Validation requirements for forming, sealing and assembly processes ASTM F1980:2021 Standard Guide for Accelerated Aging of Sterile Barrier ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye BS EN ISO 15223-1:2021 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements BS EN ISO 20417:2021 Medical Devices Information to be supplied by the manufacturer BS EN IEC 62366-1:2015+A1:2020 Medical devices Application of usability engineering to medical devices BS EN IEC 63000:2018 Technical documentation for the assessment for electrical and electronic products for the restriction of hazardous substances BS EN ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments Classification BS EN ISO 14644-2:2015 Cleanrooms and Associated Controlled Environments Monitoring
Devices
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula EPi-Sense EPi-Sense ST Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
EPi-Sense EPi-Sense ST
Cannula
Compliance (full/partial/no)
Full Full Full
Full Full Full
Full Full
Rationale if partial/no
N/A N/A N/A
N/A N/A N/A
N/A N/A
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AtriCure, Inc.
SSCP: AtriCure EPi-Sense Coagulation System
CEM-265 Rev D
9. Revision history
SSCP Revision Number A
B
Date Issued
See AtriCure MasterControl See AtriCure MasterControl
C
See AtriCure
MasterControl
D
See AtriCure
MasterControl
Change Description
Initial Release
Corrected Cannula classification rule in Section 1. Added product codes and footnotes to Section 3.2. Added description of cannula equivalency to Section 5.1. Added footnote (vi) to Section 5.3. Added descriptions of PMCF activities to Section 5.5. Updated Clinical Benefits statement to list out the 7 AF symptoms. Added Basic UDI-DI for CSK2000. Aligned Warnings for EPiSense and EPi-Sense ST to IFU-0296 and IFU-0297 by correcting a typographical error and a missing word. Corrected EU Authorised Representative address and Notified Body address from "The Netherlands" to "NL" in Section 1. Updated Section 9 Revision History table to state "Yes" for "Validated by Notified Body".
Validated by Notified Body (Yes or No) No No
No
Yes
Validation Language English English
English
English
10. Bibliography
1. DeLurgio DB, Crossen KJ, Gill J, et al. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol 2020;13:e009288.
2. Larson J, Merchant FM, Patel A, et al. Outcomes of convergent atrial fibrillation ablation with continuous rhythm monitoring. J Cardiovasc Electrophysiol 2020;31:1270-6.
3. Maclean E, Yap J, Saberwal B, et al. The convergent procedure versus catheter ablation alone in longstanding persistent atrial fibrillation: A single centre, propensity-matched cohort study. Int J Cardiol 2020;303:49-53.
4. Makati KJ, Sherman AJ, Gerogiannis I, Sood N. Safety and Efficacy of Convergent Hybrid Procedure Using Cryo as Endocardial Energy Source for the Treatment of Atrial Fibrillation. Circ Arrhythm Electrophysiol 2020;13:e008556.
5. Ellis CR, Badhwar N, Tschopp D, et al. Subxiphoid Hybrid Epicardial-Endocardial Atrial Fibrillation Ablation and LAA Ligation: Initial Sub-X Hybrid MAZE Registry Results. JACC Clin Electrophysiol 2020;6:1603-15.
6. Tonks R, Lantz G, Mahlow J, Hirsh J, Lee LS. Short and Intermediate Term Outcomes of the Convergent Procedure: Initial Experience in a Tertiary Referral Center. Ann Thorac Cardiovasc
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Surg 2020;26:13-21. 7. Gulkarov I, Wong B, Kowalski M, et al. Convergent ablation for persistent atrial fibrillation:
Single center experience. J Card Surg 2019;34:1037-43. 8. Jan M, Zizek D, Gersak ZM, Gersak B. Comparison of treatment outcomes between
convergent procedure and catheter ablation for paroxysmal atrial fibrillation evaluated with implantable loop recorder monitoring. J Cardiovasc Electrophysiol 2018;29:1073-80. 9. Zannis K, Alam W, Sebag FA, et al. The convergent procedure: a hybrid approach for long lasting persistent atrial fibrillation ablation, the French experience. J Cardiovasc Surg (Torino) 2019. 10. Kress DC, Erickson L, Choudhuri I, et al. Comparative Effectiveness of Hybrid Ablation Versus Endocardial Catheter Ablation Alone in Patients With Persistent Atrial Fibrillation. JACC Clin Electrophysiol 2017;3:341-9. 11. Toplisek J, Pernat A, Ruzic N, et al. Improvement of Atrial and Ventricular Remodeling with Low Atrial Fibrillation Burden after Hybrid Ablation of Persistent Atrial Fibrillation. Pacing Clin Electrophysiol 2016;39:216-24. 12. Thosani AJ, Gerczuk P, Liu E, Belden W, Moraca R. Closed Chest Convergent EpicardialEndocardial Ablation of Non-paroxysmal Atrial Fibrillation - A Case Series and Literature Review. Arrhythm Electrophysiol Rev 2013;2:65-8. 13. Edgerton Z, Perini AP, Horton R, et al. Hybrid Procedure (Endo/Epicardial) versus Standard Manual Ablation in Patients Undergoing Ablation of Longstanding Persistent Atrial Fibrillation: Results from a Single Center. J Cardiovasc Electrophysiol 2016;27:524-30. 14. Gehi AK, Mounsey JP, Pursell I, et al. Hybrid epicardial-endocardial ablation using a pericardioscopic technique for the treatment of atrial fibrillation. Heart Rhythm 2013;10:22-8. 15. Gersak B, Jan M. Long-Term Success for the Convergent Atrial Fibrillation Procedure: 4-Year Outcomes. Ann Thorac Surg 2016;102:1550-7. 16. Gersak B, Zembala MO, Muller D, et al. European experience of the convergent atrial fibrillation procedure: multicenter outcomes in consecutive patients. J Thorac Cardiovasc Surg 2014;147:1411-6. 17. Civello K, Smith C, Boedefeld W. Combined Endocardial and Epicardial Ablation for Symptomatic Atrial Fibrillation: Single Center Experience in 100+ Consecutive Patients. J Innovations in Cardiac Rhythm Manag 2013:1-7. 18. Gilligan D, Joyner C, Bundy G. Multidisciplinary Collaboration for the Treatment of Atrial Fibrillation: Convergent Procedure Outcomes from a Single Center. J Innovations in Cardiac Rhythm Manag 2013;4:1396-403. 19. Kiser AC, Landers M, Horton R, Hume A, Natale A, Gersak B. The convergent procedure: a multidisciplinary atrial fibrillation treatment. Heart Surg Forum 2010;13:E317-21. 20. Kiser AC, Landers MD, Boyce K, Sinkovec M, Pernat A, Gersak B. Simultaneous catheter and epicardial ablations enable a comprehensive atrial fibrillation procedure. Innovations (Phila) 2011;6:243-7. 21. Zembala M, Filipiak K, Kowalski O, et al. Staged hybrid ablation for persistent and longstanding persistent atrial fibrillation effectively restores sinus rhythm in long-term observation. Arch Med Sci 2017;13:109-17. 22. Buchta P, Sierpinski R, Myrda K, et al. New hope for patients and challenges for the multidisciplinary arrhythmia team: a hybrid convergent approach for atrial fibrillation treatment. Kardiol Pol 2020;78:1243-53. 23. Clive Robinson M, Scierka L, Chiravuri M, et al. Confluent Extended Posterior Left Atrial Wall Ablation: Thinking Inside the Box. J Innov Card Rhythm Manag 2017;8:2765-72. 24. Kress DC, Erickson L, Mengesha TW, Krum D, Sra J. Characterizing Recurrence Following Hybrid Ablation in Patients With Persistent Atrial Fibrillation. J Patient Cent Res Rev 2020;7:227-38. 25. Ibrahim Abushouk A, Ashraf Ali A, Abdou Mohamed A, et al. Rhythm Versus Rate Control for Atrial Fibrillation: A Meta-analysis of Randomized Controlled Trials. Biomedical and Pharmacology Journal 2018;11:609-20. _____________________________________________________________________________
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26. Piccini JP, Fauchier L. Rhythm control in atrial fibrillation. Lancet 2016;388:829-40. 27. Raphael CE, Friedman PA, Saw J, Pislaru SV, Munger TM, Holmes DR, Jr. Residual leaks
following percutaneous left atrial appendage occlusion: assessment and management implications. EuroIntervention 2017;13:1218-25. 28. Akin I, Nienaber CA. Left atrial appendage occlusion: A better alternative to anticoagulation? World J Cardiol 2017;9:139-46. 29. Health Quality O. Left Atrial Appendage Closure Device With Delivery System: A Health Technology Assessment. Ont Health Technol Assess Ser 2017;17:1-106. 30. Sanchez JM, Al-Dosari G, Chu S, et al. Hybrid and surgical procedures for the treatment of persistent and longstanding persistent atrial fibrillation. Expert Rev Cardiovasc Ther 2018;16:91-7. 31. Lau DH, Linz D, Sanders P. New Findings in Atrial Fibrillation Mechanisms. Card Electrophysiol Clin 2019;11:563-71. 32. Sau A, Howard JP, Al-Aidarous S, et al. Meta-Analysis of Randomized Controlled Trials of Atrial Fibrillation Ablation With Pulmonary Vein Isolation Versus Without. JACC Clin Electrophysiol 2019;5:968-76. 33. Cheniti G, Vlachos K, Pambrun T, et al. Atrial Fibrillation Mechanisms and Implications for Catheter Ablation. Front Physiol 2018;9:1458. 34. Pison L, Tilz R, Jalife J, Haissaguerre M. Pulmonary vein triggers, focal sources, rotors and atrial cardiomyopathy: implications for the choice of the most effective ablation therapy. J Intern Med 2016;279:449-56. 35. Reissmann B, Metzner A, Kuck KH. Cryoballoon ablation versus radiofrequency ablation for atrial fibrillation. Trends Cardiovasc Med 2017;27:271-7. 36. Chen YH, Lu ZY, Xiang Y, et al. Cryoablation vs. radiofrequency ablation for treatment of paroxysmal atrial fibrillation: a systematic review and meta-analysis. Europace 2017;19:78494. 37. Sugrue A, Vaidya V, Witt C, et al. Irreversible electroporation for catheter-based cardiac ablation: a systematic review of the preclinical experience. J Interv Card Electrophysiol 2019;55:251-65. 38. Goette J, Weimar T, Vosseler M, et al. Freezing Equals Freezing? Performance of Two Cryoablation Devices in Concomitant Mitral Valve Repair. Thorac Cardiovasc Surg 2016;64:672-8. 39. Harlaar N, Verberkmoes NJ, van der Voort PH, et al. Clamping versus nonclamping thoracoscopic box ablation in long-standing persistent atrial fibrillation. J Thorac Cardiovasc Surg 2019. 40. Vos LM, Bentala M, Geuzebroek GS, Molhoek SG, van Putte BP. Long-term outcome after totally thoracoscopic ablation for atrial fibrillation. J Cardiovasc Electrophysiol 2020;31:40-5. 41. Cox JL, Churyla A, Malaisrie SC, et al. A Hybrid Maze Procedure for Long-Standing Persistent Atrial Fibrillation. Ann Thorac Surg 2019;107:610-8. 42. Baykaner T, Rogers AJ, Meckler GL, et al. Clinical Implications of Ablation of Drivers for Atrial Fibrillation: A Systematic Review and Meta-Analysis. Circ Arrhythm Electrophysiol 2018;11:e006119. 43. Kim HJ, Kim JS, Kim TS. Epicardial thoracoscopic ablation versus endocardial catheter ablation for management of atrial fibrillation: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg 2016;22:729-37. 44. Chen CF, Gao XF, Liu MJ, Jin CL, Xu YZ. Safety and efficacy of the ThermoCool SmartTouch SurroundFlow catheter for atrial fibrillation ablation: A meta-analysis. Clin Cardiol 2019. 45. Macle L, Frame D, Gache LM, Monir G, Pollak SJ, Boo LM. Atrial fibrillation ablation with a spring sensor-irrigated contact force-sensing catheter compared with other ablation catheters: systematic literature review and meta-analysis. BMJ Open 2019;9:e023775. 46. Perino AC, Leef GC, Cluckey A, et al. Secular trends in success rate of catheter ablation for atrial fibrillation: The SMASH-AF cohort. Am Heart J 2019;208:110-9. 47. Virk SA, Ariyaratnam J, Bennett RG, Kumar S. Updated systematic review and meta-analysis _____________________________________________________________________________
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of the impact of contact force sensing on the safety and efficacy of atrial fibrillation ablation: discrepancy between observational studies and randomized control trial data. Europace 2019;21:239-49. 48. Zhou W, Wang L, Zhou B, Wu L. Catheter ablation of paroxysmal atrial fibrillation using highdensity mapping-guided substrate modification. Pacing Clin Electrophysiol 2018;41:1630-4. 49. Pearman CM, Poon SS, Bonnett LJ, et al. Minimally Invasive Epicardial Surgical Ablation Alone Versus Hybrid Ablation for Atrial Fibrillation: A Systematic Review and Meta-Analysis. Arrhythm Electrophysiol Rev 2017;6:202-9. 50. Salzberg SP, van Boven WJ, Wyss C, et al. "AF HeartTeam" Guided Indication for Stand-alone Thoracoscopic Left Atrial Ablation and Left Atrial Appendage Closure. J Atr Fibrillation 2019;11:2039.
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