Atri Clip Devices Left Atrial Appendage Exclusion System

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Atri. Clip Devices Left Atrial Appendage Exclusion System MKT-1542 C-G

Atri. Clip Devices Left Atrial Appendage Exclusion System MKT-1542 C-G

Atri. Clip® Gillinov-Cosgrove LAA exclusion system The ONLY COMPLETE LAA Exclusion Solution • Applied

Atri. Clip® Gillinov-Cosgrove LAA exclusion system The ONLY COMPLETE LAA Exclusion Solution • Applied epicardially not in the circulating blood • Tissue is compressed and not cut or pierced • Closure is linear and not circular so forces are applied in same orientation as the LAA anatomy • Atri. Clip addresses both mechanical and electrophysiologic aspects of LAA [ 2 ] MKT-1542 C-G

Presentation Content The ONLY COMPLETE LAA Exclusion Solution • Morphology of Left Atrial Appendage

Presentation Content The ONLY COMPLETE LAA Exclusion Solution • Morphology of Left Atrial Appendage (LAA) • Design, Key Features, IFU • Deployment Device Options (PRO, long, standard) • Pre-Clinical Peer Reviewed Data • FDA EXCLUDE Trial Results • Alternative LAA Exclusion Methods • LAA exclusion Peer Reviewed Data / Non Atri. Clip • LAA Exclusion Closure Photos [ 3 ] MKT-1542 C-G

Morphology of the LAA • Individual Variability 1 • Orifice is elliptical 2 •

Morphology of the LAA • Individual Variability 1 • Orifice is elliptical 2 • Diameter of 10 to 40 mm 3 LAA • Pectinate muscles are absent in the neck area 1 • Body contains trabeculated muscle bars, so-called pectinate muscles 3 The Neck = Area of interest Slide provided by Dr. Sacha Salzberg, University of Zurich [1] Veinot, J. P. et al. Circulation 1997; 96: 3112 -3115 [2] Su P. et al. Heart 2008; 94; 1166 -1170 [3] Savelieva et al. Stroke Prevention in Atrial Fibrillation, Annals of Medicine. 2007; 39: 371– 391 [ 4 ] MKT-1542 C-G

Design and materials External Knit Braided Polyester promotes rapid in-growth Other applications of the

Design and materials External Knit Braided Polyester promotes rapid in-growth Other applications of the materials: • Nitinol – stents & coils • Titanium – orthopedics • Carbothane – leads and patches • Polyester – valve rings and grafts [ 5 ] MKT-1542 C-G Rigid Titanium Core structural backbone

Design and materials External Knit Braided Polyester promotes rapid in-growth Rigid Titanium Core structural

Design and materials External Knit Braided Polyester promotes rapid in-growth Rigid Titanium Core structural backbone Outer Urethane Extrusion distributes clamping pressure Super Elastic Nitinol Spring provides parallel clamp closure Other applications of the materials: • Nitinol – stents & coils • Titanium – orthopedics • Carbothane – leads and patches • Polyester – valve rings and grafts [ 6 ] MKT-1542 C-G 90 Design minimizes contact with adjoining structures

Key Features Parallel beams • Follows natural orientation of appendage orifice • Equalizes force

Key Features Parallel beams • Follows natural orientation of appendage orifice • Equalizes force over the length of appendage Nitinol springs • Dynamic compression force (continues to close over time) • Force is proportional to tissue thickness and an order of magnitude less than staplers or suture [ 7 ] MKT-1542 C-G Tissue approximation at implant Courtesy of Marc Gerdisch, MD

Key Features Polyester fiber sleeve • Encourages rapid tissue in growth • Provides stability

Key Features Polyester fiber sleeve • Encourages rapid tissue in growth • Provides stability while LAA is reabsorbed • Yields smooth healing of the endocardium at the LAA LA junction 7 day in growth, porcine model Human Endocardial View at 4 months [ 8 ] MKT-1542 C-G

Deployment Device Options Atri. Clip PRO • Quick Deploy feature • Head Articulation ≥

Deployment Device Options Atri. Clip PRO • Quick Deploy feature • Head Articulation ≥ 30° side to side / up & down w/lock feature • Rigid Shaft (25 mm) [ 9 ] MKT-1542 C-G

Deployment Device Options Atri. Clip long • Head Articulation 180° side to side •

Deployment Device Options Atri. Clip long • Head Articulation 180° side to side • Thumb control • Malleable Shaft (25 mm) [ 10 ] MKT-1542 C-G

Deployment Device Options Atri. Clip standard • Head Articulation • Plunger Grip • Stiff

Deployment Device Options Atri. Clip standard • Head Articulation • Plunger Grip • Stiff Shaft (6 mm) [ 11 ] MKT-1542 C-G

Instructions for use Contraindications • Tubal occlusion • Known allergy to Nickel (Nitinol) Warnings

Instructions for use Contraindications • Tubal occlusion • Known allergy to Nickel (Nitinol) Warnings • Do not attempt to reposition or remove the Clip 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 ensure that you remind surgeon of this procedural step in advance • Do not use on LAA <29 mm or >50 mm or <1 mm wall thickness MRI • MRI Conditional due to artifacts • Less than 3 Tesla [ 12 ] MKT-1542 C-G

Pre-clinical and Clinical Results Atri. Clip LAA Exclusion Device [ 13 ]

Pre-clinical and Clinical Results Atri. Clip LAA Exclusion Device [ 13 ]

Long Term Atrial Remodeling Demonstrated in Pre-Clinical Models Key Aspects • Mechanical Isolation –

Long Term Atrial Remodeling Demonstrated in Pre-Clinical Models Key Aspects • Mechanical Isolation – acute through 180 d study confirmed lack of communication and clip stability. • Migration – acute through 180 d study confirmed clip stability • Electrical Isolation – stimulation of tissue distal to clip confirmed lack of electrical viability (90 d) • MRI Safety and Imaging Quality – imaging as part of the papio study and with 3 rd party MR experts, confirmed MRI Conditional. • Long Term Cardiac Function – appendage closure without disrupting atrial flow [ 14 ] MKT-1542 C-G

Pre-Clinical Atri. Clip Studies • A novel device for left atrial appendage exclusion Keiji

Pre-Clinical Atri. Clip Studies • A novel device for left atrial appendage exclusion Keiji Kamohara, MDa , Kiyotaka Fukamachi, MD, Ph. Da*, Yoshio Ootaki, MD, Ph. Da, Masatoshi Akiyama, MD, Ph. Da, Firas Zahr, MDa, Michael W. Kopcak, Jr, BAa, Raymond Dessoffy, AAa, Zoran B. Popovi, MDa, Masao Daimon, MDb, Delos M. Cosgrove, MDc, A. Marc Gillinov, MDc J Thorac Cardiovasc Surg 2005; 130: 1639 -1644 © 2005 The American Association for Thoracic Surgery • Evaluation of a novel device for left atrial appendage exclusion: the second-generation atrial exclusion device Kamohara K, Fukamachi K, Ootaki Y, Akiyama M, Cingoz F, Ootaki C, Vince DG, Popović ZB, Kopcak MW Jr, Dessoffy R, Liu J, Gillinov AM. J Thorac Cardiovasc Surg. 2006 Aug; 132(2): 340 -6. [ 15 ] MKT-1542 C-G

Pre-Clinical Atri. Clip Studies • A novel device for left atrial appendage exclusion: The

Pre-Clinical Atri. Clip Studies • A novel device for left atrial appendage exclusion: The third-generation atrial exclusion device Hideyuki Fumoto, MDa, A. Marc Gillinov, MDb, Yoshio Ootaki, MD, Ph. Da, Masatoshi Akiyama, MD, Ph. Da, Diyar Saeed, MDa, Tetsuya Horai, MDa, Chiyo Ootaki, MDa, D. Geoffrey Vince, Ph. Da, Zoran B. Popovi, MDc, Raymond Dessoffy, AAa, Alex Massiello, MEBMEa, Jacquelyn Catanese, MAa, Kiyotaka Fukamachi, MD, Ph. Da, * J Thoracic Cardiovasc Surg 2008; 136: 1019 -1027 © 2008 The American Association for Thoracic Surgery • Surgical left atrial appendage occlusion: evaluation of a novel device with magnetic resonance imaging Sacha P. Salzberga, 1, *, Alan Marc Gillinovb, Anelechi Anyanwua, Javier Castilloa, Farzan Filsoufia, David H. Adamsa Eur J Cardiothoracic Surg 2008; 34: 766 -770. doi: 10. 1016/j. ejcts. 2008. 058 Copyright © 2008, European Association for Cardio-Thoracic Surgery. [ 16 ] MKT-1542 C-G

LAA Occlusion with the Atri. Clip Device Implant At Explant Tissue In Growth Endocardial

LAA Occlusion with the Atri. Clip Device Implant At Explant Tissue In Growth Endocardial Closure [ 17 ] MKT-1542 C-G

(RAA) Occlusion with Stapler Implant At Explant Tissue In Growth Endocardial Closure • Cleared

(RAA) Occlusion with Stapler Implant At Explant Tissue In Growth Endocardial Closure • Cleared under 510(k) K 093679 • The Atri. Clip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. • Atri. Clip® LAA Exclusion System Possible complications related to surgical LAA exclusion, apart from those that may occur as a result of surgical/ mechanical manipulation of the target tissues, include, but are not limited to: tissue trauma, dehiscence, tissue tearing, displacement, lack of desired homeostasis. • This material is intended to provide general information, including opinions and recommendations, contained herein for educational purposes only. Such information is not intended to be a substitute for professional medical advice, diagnosis or treatment. The material is not intended to direct clinical care in any specific circumstance. The judgment regarding a particular clinical procedure or treatment plan must be made by a qualified physician in light of the clinical data presented by the patient and the diagnostic and treatment options available. MKT-1542 C-G [ 18 ] MKT-1542 C-G

Clinical Atri. Clip Peer Reviewed Articles • Epicardial left atrial appendage clip occlusion also

Clinical Atri. Clip Peer Reviewed Articles • Epicardial left atrial appendage clip occlusion also provides the electrical isolation of the left atrial appendage (MKT-1632 -G) Christoph T. Starcka, Jan Steffelb, Maximilian Y. Emmerta, Andre Plassa, Srijoy Mahapatrac, Volkmar Falka and Sacha P. Salzberga, *; Interactive Cardio. Vascular and Thoracic Surgery 0 (2012) 1– 3; doi: 10. 1093/icvts/ivs 136; • Exclusion of the left atrial appendage with a novel device: Early results of a multicenter trial (MKT-1579 -G) Gorav Ailawadi, Mda, Marc. W. Gerdisch, MDb, Richard L. Harvey, MDc, Robert L. Hooker, MDd, Ralph J. Damiano, Jr, Mde, Thomas Salamon, MDf, and Michael J. Mack, MDg The Journal of Thoracic and Cardiovascular Surgery 2011; -: 1 -8 • Thoracoscopic Appendage Exclusion With an Atriclip Device As a Solo Treatment for Focal Atrial Tachycardia Stefano Benussi, MD, Ph. D; Patrizio Mazzone, MD; Giuseppe Maccabelli, MD; Ottavio Alfieri, MD; Paolo Della Bella, MD (Circulation. 2011; 123: 1575 -1578. ); DOI: 10. 1161/CIRCULATIONAHA. 110. 005652; MKT-1635 -U [ 19 ] MKT-1542 C-G

Clinical Atri. Clip Peer Reviewed Articles • Left atrial appendage clip occlusion: Early clinical

Clinical Atri. Clip Peer Reviewed Articles • Left atrial appendage clip occlusion: Early clinical results (MKT-1400 -U) Sacha P. Salzberg, MDa, *, Andre Plass, MDa, Maximillian Y. Emmert, MDa, Lotus Desbiolles, MDb, Hatem Alkadhi, MDb, Jurg Grünenfelder, MDa, Michele Genoni, MDa J Thorac Cardiovasc Surg 2010; 139: 1269 -1274 • Epicardial left atrial appendage clip occlusion also provides the electrical isolation of the left atrial appendage (MKT-1632 A-G) Christoph T. Starcka, Jan Steffelb, Maximilian Y. Emmerta, Andre Plassa, Srijoy Mahapatrac, Volkmar Falka and Sacha P. Salzberga, *; Interactive Cardio. Vascular and Thoracic Surgery 0 (2012) 1– 3; doi: 10. 1093/icvts/ivs 136; [ 20 ] MKT-1542 C-G

EXCLUDE Trial Overview FDA trial to evaluate the safety and efficacy of the Atri.

EXCLUDE Trial Overview FDA trial to evaluate the safety and efficacy of the Atri. Clip™ LAA Exclusion System for the exclusion of the LAA via epicardial tissue approximation • Prospective, Non-randomized (N= 70 patients) • Open chest during concomitant cardiac surgery • Multi-Center (7) [ 21 ] • Baylor Heart Hospital – Plano, TX • University of Virginia – Charlottesville, VA • Barnes-Jewish Hospital/Washington University – St. Louis, MO • Spectrum Health – Grand Rapids, MI • Macon Cardiovascular Institute – Macon, GA • St. Francis – Indianapolis, IN • Mt. Carmel – Columbus, OH MKT-1542 C-G

Definition of Exclusion Complete exclusion of the LAA is defined as no communication (blood

Definition of Exclusion Complete exclusion of the LAA is defined as no communication (blood flow) between the LAA and LA as evidenced by contrast enhanced CT Scan at 3 months post implant. [ 22 ] MKT-1542 C-G

Inclusion Criteria INCLUSION CRITERIA 1. Subject is greater than or equal to 18 years

Inclusion Criteria INCLUSION CRITERIA 1. Subject is greater than or equal to 18 years of age. 2. Subject has any one of the following risk factors and is thought to benefit from LAA exclusion • • • [ 23 ] MKT-1542 C-G CHADS score > 2 Age > 75 years Hypertension and age > 65 years History of atrial fibrillation (any classification) Previous stroke

Type of Concomitant Surgery Type of Surgery N* % Patients CABG 24/68 35% AVR

Type of Concomitant Surgery Type of Surgery N* % Patients CABG 24/68 35% AVR 8/68 12% MVR 5/68 7% AVR, MVR 1/68 2% MVR, CABG 6/68 9% AVR, CABG 18/68 26% MVR, TVR 3/68 4% MVR, AVR, CABG 1/68 2% AVR, TVR, CABG 2/68 3% MAZE 22/68 32% [ 24 ] MKT-1542 C-G

Patient Risk Factors [ 25 ] MKT-1542 C-G

Patient Risk Factors [ 25 ] MKT-1542 C-G

Primary Safety Endpoint Analysis All clip implants attempted were successfully deployed [ 26 ]

Primary Safety Endpoint Analysis All clip implants attempted were successfully deployed [ 26 ] MKT-1542 C-G

Outcomes (N=70) • 70/70 clips successfully implanted • 69/70 complete exclusion confirmed by intra-op

Outcomes (N=70) • 70/70 clips successfully implanted • 69/70 complete exclusion confirmed by intra-op TEE • 60/61 exclusion confirmed by 3 month by CT scan • No device or clip procedure related adverse events reported in the study • No evidence of clip migration on any CT evaluation [ 27 ] MKT-1542 C-G

EXCLUDE Trial Note Card (MKT-1531 A-G) [ 28 ] MKT-1542 C-G

EXCLUDE Trial Note Card (MKT-1531 A-G) [ 28 ] MKT-1542 C-G

Alternative LAA Exclusion Methods Atri. Clip vs. Staple (similar challenges apply to NEW staple

Alternative LAA Exclusion Methods Atri. Clip vs. Staple (similar challenges apply to NEW staple variation device) 1) Optimize compression on tissue 2) Continuous beam versus individual staple legs 3) Continuous compression versus box height 4) Non-piercing vs. Piercing 5) Reaching the LAA base Atri. Clip vs. Loop Snare 1) Parallel vs. Noose 2) Spring Loaded Beams vs. Manually Drawn Fine Suture [ 29 ] MKT-1542 C-G

Atri. Clip vs. Staple 1) Optimize compression on tissue Theory: Pressure Varies with Tissue

Atri. Clip vs. Staple 1) Optimize compression on tissue Theory: Pressure Varies with Tissue thickness between 2 -8 psi ~60 psi Stapler forces are related to the force needed to form (bend) the staple wire, they have nothing to do with the proper force to approximate tissue. Staplers generate in excess of 60 lbs of clamping force which gets translated directly to and through the tissue. The clip generates only enough clamp force needed to approximate tissue which is specific to the length of the appendage. Clip forces have been derived from multiple chronic animal studies and further validated by human studies verifying acute and chronic closure by TEE and CT scan. Why is this Important: The LAA often is composed of friable tissue. High clamping forces pose two risks: • the risk of tissue tearing due to initial compression • the risk of weakening tissue and perforation if the device needs to be repositioned [ 30 ] MKT-1542 C-G 2 -8 psi

Atri. Clip vs. Staple 2) Continuous beam versus individual staple legs Theory: Staplers create

Atri. Clip vs. Staple 2) Continuous beam versus individual staple legs Theory: Staplers create individual points of approximation. This concept works very well on homogenous tissue such as bowel however there is limited data on trabeculated muscle. The clips continuous beams create a uniform force along the length using two compliant elements, fabric cover and the carbathane tubes. Why is this important: Our goal is to create uniform anastomosis across a heterogeneous surface. The staple lines have inconsistent pressure and there is no data that the anastomosis is consistent. Our studies have shown consistent performance along the length, in 3 species and in various tissue thicknesses (pigs, dogs, primate). [ 31 ] MKT-1542 C-G

Atri. Clip vs. Staple 3) Continuous compression versus box height Theory: A stapler is

Atri. Clip vs. Staple 3) Continuous compression versus box height Theory: A stapler is design to maintain viable tissue within the staple line. Once fired the staple height does not change. The clip’s nitinol springs provide continuous closing force on the LAA orifice over time. Why this is important: Our goal is to ASSURE no mechanical or electrical communication between the appendage and the LA. Viable tissue within the staple line can heal and recannulate over time. In addition electrical firings from the LAA are uninterrupted by staples. The clip provides dynamic closure so that as atrophy occurs the clip continues to block mechanical and electrical communication until the LAA is fully reabsorbed. [ 32 ] MKT-1542 C-G

Atri. Clip vs. Staple 4) Piercing vs. non-piercing Theory: A stapler relies on staple

Atri. Clip vs. Staple 4) Piercing vs. non-piercing Theory: A stapler relies on staple wire legs piercing tissue, hitting an anvil on the other side, bending and piercing back through the tissue; thus every staple pierces the tissue 4 times. The clip is intended to create external compression without piercing the tissue. The clip is designed to be as atraumatic as possible. Why this is important: The LAA is friable, piercing the tissue invariably weakens the tissue. A typical 6 row stapler will put down 60+ staples over a 4 cm distance meaning the tissue will be pierced 240 times. If you need a second firing (which happens occasionally), then 240 becomes 480 pierces of the tissue. [ 33 ] MKT-1542 C-G

Atri. Clip vs. Staple 5) Reaching the LAA base Theory: The optimal LAA exclusion

Atri. Clip vs. Staple 5) Reaching the LAA base Theory: The optimal LAA exclusion device should have the smallest height dimension available to increase visibility and positioning at the base of the appendage. Why this is important: A stapler has a height of roughly. 8 cm while the clip and the deployment tool have a height of . 5 cm. Positioning the clip at the base decreases the potential for creating a pro-thrombotic LA/LAA cul-desac. [ 34 ] MKT-1542 C-G

Atri. Clip vs. Loop Snare 1) Parallel vs. Noose Theory: Snares draw all of

Atri. Clip vs. Loop Snare 1) Parallel vs. Noose Theory: Snares draw all of the tissue to a central point. The appendage is not a circular structure and can vary between 30 -50 mm in length and 10 -15 mm in width. Drawing tissue to a central point requires up to 25 mm of tissue to travel using a radial closure approach. This results in high pressure areas and the potential tissue to fold rather than close uniformly. The clip compresses tissue in the same plane as the LAA orifice. No tissue moves more than the widest opening (~7 mm distance) of the orifice. Why this is important: A loop snare closure creates disproportionate forces on areas where tissue needs to move the farthest. These high stress concentrations have the potential to tear due to the high uneven forces applied. Trabeculated tissue can compound the uneven forces even further. The clip avoids stress concentrations by applying a uniform load along a parallel closure surface. The area of highest stress (the point on the oval moving the most) with our clip is equal to the area of lowest stress on the loop snare. [ 35 ] MKT-1542 C-G

Atri. Clip vs. Loop Snare 2) Spring Loaded Beams vs. Manually Drawn Fine Suture

Atri. Clip vs. Loop Snare 2) Spring Loaded Beams vs. Manually Drawn Fine Suture Theory: Fine suture 1/2 mm is typically used for a loop snare. The amount of force is entirely user dependent and is subject to a surgeon’s tactile feel. Loads increase linearly as the tissue is approximated and the knot is advanced. The clip has a much broader surface (~2. 5 mm) which distributes a smaller load (the tissue only needs to move ~7 mm) and force is not subject to surgeon technique. Why this is important: Tissue needs to be approximated in the most atraumatic manner possible and support optimal anastomosis. Pressure is the force divided by the contact area. The force required to close with a loop snare is higher and the contact area is significantly smaller, thus the pressure at the ends of the oval shape of the appendage is at 5 -10 x that of our clip. Loop snares are subject to surgeon technique. Clip pressure is pre-determined by clip size and proportional to the length of the appendage. Wider contact area and a more uniform contact surface minimizes trauma. [ 36 ] MKT-1542 C-G

LAA exclusion Peer Reviewed Data / Non Atri. Clip • Surgical left atrial appendage

LAA exclusion Peer Reviewed Data / Non Atri. Clip • Surgical left atrial appendage ligation is frequently incomplete: a transesophageal echocardiographic study Edward S. Katz, MD, FACCa, Theofanis Tsiamtsiouris, MDa, Robert M. Applebaum, MD, FACCa, Arthur Schwartzbard, MD, FACCa, Paul A. Tunick, MD, FACCa and Itzhak Kronzon, MD, FACCa J Am Coll Cardiol, 2000; 36: 468 -471 © 2000 by the American College of Cardiology Foundation • Success of Surgical Left Atrial Appendage Closure Assessment by Transesophageal Echocardiography Anne S. Kanderian, MD*, A. Marc Gillinov, MD, Gosta B. Pettersson, MD, Ph. D, Eugene Blackstone, MD and Allan L. Klein, MD, FACC, J Am Coll Cardiol 2008; 52: 924 -929, doi: 10. 1016/j. jacc. 2008. 03. 067 © 2008 by the American College of Cardiology Foundation • Left Atrial Appendage Occlusion Study (LAAOS): Results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke Jeff S. Healey, MD, a Eugene Crystal, MD, b Andre Lamy, MD, a Kevin Teoh, MD, a Lloyd Semelhago, MD, a Stefan H. Hohnloser, MD, c Irene Cybulsky, MD, a Labib Abouzahr, MD, a Corey Sawchuck, MD, a Sandra Carroll, BSc, a Carlos Morillo, MD, a Peter Kleine, MD, c Victor Chu, MD, a Eva Lonn, MD, a and Stuart J. Connolly, Mda Am Heart J 2005; 150: 288 -93. [ 37 ] MKT-1542 C-G

LAA Occlusion Photos [ 38 ]

LAA Occlusion Photos [ 38 ]

Acute LAA Exclusion with Stapler Porcine Model DCR 1251 [ 39 ] MKT-1542 C-G

Acute LAA Exclusion with Stapler Porcine Model DCR 1251 [ 39 ] MKT-1542 C-G

Endocardial View of LAA Exclusion with Stapler @ 90 Days Porcine Model DCR 1251

Endocardial View of LAA Exclusion with Stapler @ 90 Days Porcine Model DCR 1251 [ 40 ] MKT-1542 C-G

Acute Implant of Atri. Clip Porcine Model DCR 1251 [ 41 ] MKT-1542 C-G

Acute Implant of Atri. Clip Porcine Model DCR 1251 [ 41 ] MKT-1542 C-G

Acute Implant – CABG Procedure Courtesy of Dr. Marc Gerdisch [ 42 ] MKT-1542

Acute Implant – CABG Procedure Courtesy of Dr. Marc Gerdisch [ 42 ] MKT-1542 C-G

Acute Implant – LAA Incised to Evaluate Closure Courtesy of Dr. Marc Gerdisch [

Acute Implant – LAA Incised to Evaluate Closure Courtesy of Dr. Marc Gerdisch [ 43 ] MKT-1542 C-G

Acute Endocardial Closure of LAA Ostium Courtesy of Dr. Marc Gerdisch [ 44 ]

Acute Endocardial Closure of LAA Ostium Courtesy of Dr. Marc Gerdisch [ 44 ] MKT-1542 C-G

Chronic Left Atrial Wall @ 4 Months Courtesy of Dr. Marc Gerdisch [ 45

Chronic Left Atrial Wall @ 4 Months Courtesy of Dr. Marc Gerdisch [ 45 ] MKT-1542 C-G

Failed Chronic Endocardial Suture Image courtesy of Dr. Rafael Squitieri, St. Vincent’s, Bridgeport, CT

Failed Chronic Endocardial Suture Image courtesy of Dr. Rafael Squitieri, St. Vincent’s, Bridgeport, CT [ 46 ] MKT-1542 C-G

This material is intended to provide general information, including opinions and recommendations, contained herein

This material is intended to provide general information, including opinions and recommendations, contained herein for educational purposes only. Such information is not intended to be a substitute for professional medical advice, diagnosis or treatment. The material is not intended to direct clinical care in any specific circumstance. The judgment regarding a particular clinical procedure or treatment plan must be made by a qualified physician in light of the clinical data presented by the patient and the diagnostic and treatment options available. The Atri. Clip™ LAA Exclusion System is indicated for the occlusion of the heart’s left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Atri. Clip® LAA Exclusion System Possible complications related to surgical LAA exclusion, apart from those that may occur as a result of surgical/ mechanical manipulation of the target tissues, include, but are not limited to: tissue trauma, dehiscence, tissue tearing, displacement, lack of desired homeostasis. [ 47 ] MKT-1542 C-G