CONFORM Pivotal Trial Site Recruitment Meeting

Published: 16 June 2021

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    Welcome and Introductions
    Andy Levine, Aaron Kaplan, Chris Cain, William Gray, Shephal Doshi, Vivek Reddy
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Overview

The CONFORM Pivotal Trial is a prospective, multi-center randomized controlled trial, designed to evaluate the safety and effectiveness of the Conformal Left Atrial Appendage Seal (CLAAS®). Subjects will be randomized in a 1:1 fashion between the CLAAS device (treatment) or a Boston Scientific LAA closure device (Control).

 

If interested in participating in the Conform Pivotal Study, please contact Karis Oasan, Clinical Trial Manager koasan@conformalmedical.com.

 

For more information on Conformal Medical, Inc click HERE to visit our website.

This session is a clinical trial recruitment event.

Target Audience

  • Interventional Cardiologists
  • Electrophysiologists
  • All sites specialising in LAA procedures or doing research in this space

More from this programme

Part 1

Welcome and Introductions

Presented by Andy Levine

Part 2

CLAAS Overview

Presented by Dr Aaron Kaplan

Part 3

Initial Clinical Experience

Presented by Dr Aaron Kaplan

Part 4

Case Study and Panel Discussion 1

Presented by Dr William Gray with discussion moderated by Dr Aaron Kaplan and Dr Shephal Doshi

Part 5

Case Study and Panel Discussion 2

Presented by Dr Vivek Reddy with discussion moderated by Dr Aaron Kaplan and Dr Shephal Doshi

Part 6

CONFORM Pivotal Trial Summary

Presented by Chris Cain

Part 7

Closing Remarks

Presented by Dr Aaron Kaplan

Faculty Biographies

Andy Levine

Andy Levine

CEO and Co-Founder of Conformal Medical, Inc

Andy is an entrepreneur with over thirty-five years of engineering, marketing and general business experience developing medical devices and starting companies.  Andy is CEO and Co-founder of Conformal Medical, Inc., a clinical stage company developing Left Atrial Appendage closure technologies. 

He previously held a position in Business Development for medical devices at Harvard’s Wyss Institute for Biologically Inspired Engineering.  In 2003, Andy founded GI Dynamics which developed an endoscopic device for the treatment of diabetes.  He possesses technical expertise in biomaterials, mechanism design, fluid mechanics and heat transfer, holds over 85 patents and has authored over 20 technical publications.  

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Aaron Kaplan

Aaron Kaplan

Chairman and Chief Medical Officer

Aaron Kaplan is an active medical device entrepreneur who has been on the founding team of a number of venture-backed medical device companies including Conformal Medical, Tryton Medical, LocalMed and Perclose (acquired by Abbott).  He has consulted to many medical device companies and was an Entrepreneur-In-Residence at Three Arch Partners.

 

Aaron is a practicing interventional cardiologist at Dartmouth-Hitchcock Medical Center and a Professor of Medicine at the Geisel School of Medicine at Dartmouth. In addition, he directs the Synergy Clinician-Entrepreneur Fellowship and chairs the Dartmouth Device Development Symposium. Prior to joining the Dartmouth Faculty, Dr. Kaplan was Director of Interventional Cardiology at…

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Chris Cain

Chris Cain

Vice President of Clinical and Regulatory Affairs

Chris is a medical device industry veteran who has spent more than 20 years supporting the development of Class II and III medical devices.

Chris joined Conformal Medical in 2018 and serves as Vice President of Clinical & Regulatory Affairs for the company. Most recently he was Vice President of Clinical & Regulatory Affairs at Corindus Vascular Robotics. He has held global clinical and regulatory positions at ZOLL, Edwards Lifesciences, VNUS, CVRx and Medtronic.

Prior to entering the medical device industry, Chris was an Intensive Care and Cardiac Cath Lab nurse. While in nursing school, Chris served in the Army Reserves as an Army Aviator. Chris holds a B.S.N. in Nursing from Central Missouri State University, and an MBA…

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William Gray

William Gray

President of the Lankenau Heart Institute

Dr William Gray is an interventional cardiologist, board certified in internal medicine, cardiology, interventional cardiology, vascular medicine and endovascular medicine.  He was at the Center for Interventional Vascular Therapy (CIVT) as Director, Endovascular Intervention at New York Columbia-Presbyterian Hospital from 2005-2015 before joining the Main Line Health System in Wynnewood, Pennsylvania.   He specializes in cardiac/structural and peripheral arterial disease diagnosis and treatment with a special interest in new, non-surgical modalities for stroke prevention (carotid stenting and left atrial appendage occlusion devices), and research into preventing the reoccurrence of disease following successful angioplasty or stenting.  He has also dedicated a significant portion of the past decade of his career to the non-surgical management of mitral regurgitation.

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Shephal Doshi

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Vivek Reddy

Vivek Reddy

Director of Cardiac Arrhythmia Services

Dr Vivek Y. Reddy is Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and Director of Electrophysiology for the Mount Sinai Health System, and The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai.

Dr Reddy is one of the US's premier cardiac electrophysiologists. He leads a team of physician-scientists who are developing and testing advanced therapies for cardiac arrhythmias and heart failure, including catheter ablation for atrial fibrillation and ventricular tachycardia, and device therapies for stroke prevention. Under his leadership, Mount Sinai is the lead investigational site for many multinational clinical trials exploring new arrhythmia procedures and technologies, most recently pulsed field ablation to treat atrial fibrillation. Moreover, in 2014, he implanted the world’s first miniature leadless pacemaker, as well as the first leadless pacemaker in…

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