AtriClip PRO2 TM Device - PowerPoint Presentation

Slide1

AtriClip PRO2TM Device

Product Overview

MKT-2387A-G

LAA Management Guidelines

MKT-2387A-G

Society

Recommendation

STS (2017)

“It is REASONABLE to perform left atrial appendage excision or exclusion in conjunction with surgical ablation for AF for longitudinal thromboembolic morbidity prevention. (Class IIA, Level C limited data)” 

“At the time of concomitant cardiac operations in patients with AF, it is REASONABLE to surgically manage the left atrial appendage for longitudinal thromboembolic morbidity prevention. (Class IIA, Level C expert opinion)” 

ESC (2016)

“LAA occlusion may be considered for stroke prevention in patients

with AF and contra-indications for long-term anticoagulant treatment

(Class

IIb

, Level B)”.

“Surgical occlusion or exclusion of the LAA may be considered for stroke prevention in patients with AF undergoing cardiac surgery (Class

IIb

, Level B)”.

“Surgical occlusion or exclusion of the LAA may be considered for stroke prevention in patients undergoing

thoracoscopic

AF surgery (Class

IIb

, Level B)”.

UK NICE (2014)

"Consider LAA occlusion if anticoagulation is contraindicated or not tolerated and discuss the benefits and risks of LAAO with patient."

EJCTS (2013)

"We conclude that there has been no proven benefit of surgical LAA exclusion in terms of stroke reduction or mortality benefit… If exclusion is contemplated, devices designed for appendage exclusion should be used rather than a cut-and-sew or stapling technique."

AtriClip Pro2 Device - Designed to

Simplify the Approach to LAA Exclusion

MKT-2386A-G

AtriClip Pro2 Device - Designed to

Simplify the Approach to LAA Exclusion

MKT-2386A-G

Applied epicardially not in the circulating blood during stand-alone approach

Applicable regardless of LAA morphology

1

Addresses mechanical aspect of LAA

Over 100.000 implants worldwide

Does not mandate any post-operative systemic anticoagulant therapy

1 Do not use on LAA <29mm or >50mm or <1mm wall thickness

LAA Management Options

MKT-2386A-G

Mechanism of Closure

External Tissue

compression

Mechanical cut and suture

Manual

cut and suture

Endocardial

occlusion

Force applied

Uniform and continuous

Individual points of approximation

High

stress points (radial closure)

N.A.

LAA indicationyesnoyesyesType of tissue designed forLAA –epicardial tissue Abdominal, gynecologic, pediatric and thoracic tissueApproximation of displaced tissue-any typeLAA – endocardial tissue

AtriClip Pro2 Device – AtriClip® Structure

MKT-2386A-G

Continues to close as the tissue atrophies

Promotes rapid in-growth

Distributes clamping pressure

Provides parallel clamp closure

Minimizes contact with adjoining structures

AtriClip Pro2 Device – Easy of Use

MKT-2386A-G

12mm Diameter End Effector

Allows for enhanced visualization in the chest cavity and/or transverse sinus

Fits 12mm trocar

Can be used in totally thoracoscopic procedures

AtriClip Pro2 Device – Easy of Use

MKT-2386A-G

Active Articulation Levers

Remotely/actively control the end effector for +/- 30 degree pitch and yaw

AtriClip Pro2 Device – Performance

MKT-2386A-G

LAA Mechanical Isolation

In preclinical and clinical studies, the AtriClip® device securely sealed the LAA orifice resulting in a smooth endothelial tissue surface within 90 days

Prospective, Multicenter, Non-randomized (N= 70 patients)

Open chest during concomitant cardiac surgery

70/70 clips successfully implanted

67/70 complete exclusion confirmed by intra-op TEE (>95%)

60/61 exclusion confirmed by 3 month by CT scan (> 98%)

No device or clip procedure related adverse events reported

No evidence of clip migration on any CT evaluation

Ailawadi

G,

Gerdisch

MW, Harvey RL, et al. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J

Thorac

Cardiovasc

Surg 2011;142:1002–9

AtriClip Pro2 Device – Performance

MKT-2386A-G

Safety

The AtriClip device provides safe and atraumatic exclusion of the LAA during open and endoscopic cardiac surgery

Emmert et al. Safe, Effective and Durable

Epicardial

Left Atrial Appendage Clip Occlusion in Patients with Atrial Fibrillation Undergoing Cardiac Surgery: First Long-Term Results from a Prospective Device Trial, European Journal of Cardio-Thoracic Surgery 2013

“Herein we report the first long-term outcome data on

epicardial

LAA clip application during open heart surgery. In addition to being

100% effective and safe in the short term

, the results of this prospective device trial demonstrate the durable occlusion of the LAA for

over 3 years

with excellent clinical outcomes.

Importantly, during follow-up, no strokes occurred and anticoagulation could be often discontinued, most often decided by general practitioners and referring cardiologists

. “

Thank you for your attention

AtriClip PRO2 Device - Indication for Use

Indication for use

The AtriClip LAA Exclusion System is indicated for the occlusion of the heart’s left atrial appendage

Contraindications

Tubal occlusion

Known allergy to Nickel (Nitinol)

Warnings

Do not attempt to reposition or remove the device after deployment

Do not use this device if the patient has sensitivity to nickel

Precautions

Pre-op or intra-op confirmation that no thrombus is present in appendage prior to clip placement is required. As this may not be routinely performed in all procedures, remind surgeon of this procedural step in advance

Do not use on LAA <29mm or >50mm or <1mm wall thickness

MRIMRI Conditional due to artifactsLess than 3 TeslaMKT-2386A-G