/  ISCTR – TCT 2018 Summit
Summit on Translational Pathways for Cardiovascular Devices

ISCTR - TCT 2018 Summit

September 21, 2018
San Diego Convention Center
111 West Harbor Drive
San Diego, California
8:00 am – 5:00 pm

Program Directors:

Nabil Dib, Bram Zuckerman, Spencer King, Martin Leon


To Present and Discuss the final consensus on Translational Pathway for Cardiovascular Device Development and Iteration for Cardiovascular Diseases (Valvular Disease, Coronary Artery Disease, Arrhythmia and Heart Failure) That Incorporates Input from Academia, Industry, FDA, and Payers.


8:00 – 8:05 AM

Welcome Statement

Spencer King 

8:05 – 8:20 AM

ISCTR Mission and Statement of Meeting Purpose

–  Nabil Dib

Session I – Requirements for CV Devices Approval; Regulatory, Payers, and Practice Guidelines

Moderators: Bram Zuckerman, Spencer King Bram Zuckerman 

8:20 – 8:35 AM

Regulatory Requirement for Marketing Approval including the Parallel Review, NEST, and Beyond

Bram Zuckerman

8:35 – 8:50 AM

CMS Requirement for Reimbursement for Innovation

Lori Ashby

8:50 – 9:05 AM

Practice Guideline Requirement for New Technology

– Alice Jacobs

9:05 – 9:20 AM

Pre-Clinical and Clinical Trial Design and Endpoints for Device Approval

– Roseann White, Chris Mullin 

9:20 – 9:35 AM

Early Feasibility Studies for Device Evaluation

– Andrew Farb

9:35 – 9:45 AM

The Patients Voice

– Mark Marcola

9:45 – 10:15 AM

Panel Discussion:  
– Lori Ashby, Alice Jacobs, Roseann White, Chris Mullin, Andrew Farb, Mitchell Krucoff, Stan Rowe, Charles Simonton, Robert Bonow, Louis Jacques, Phil Adamson, David Reuter 

10:15 – 10:30 AM


Session II – ISCTR Award Presentation and Keynote Address

Moderators: Stan Rowe, Robert Bonow

Award Presentation:

10:30 – 10:40 AM

Presentation of the Glen and Marilyn Nelson Award for Innovation and Translation in Cardiovascular Medicine to Alain Cribier and Martin Leon presented by Stan Rowe and Robert Bonow

10:40 – 10:45 AM

Video Presentation of the Glen and Marilyn Nelson Award for Innovation and Translation in Cardiovascular Medicine

Keynote Address:

10:45 – 11:05 AM

The TAVR Development from Concept to First in Man
– Alain Cribier, Nelson Award Recipient

11:05 – 11:25 AM

The TAVR Development from First in Man to Phase 3 and  Beyond

– Martin Leon, Nelson Award Recipient

11:25 – 12:00 PM


Session III – Translational Pathway for Transcatheter Aortic Valves

Moderators: Martin Leon, Jeroen Bax

12:00 – 12:15 PM

The Methods for Transcatheter Aortic Valve Development
– Stan Rowe 

12:15 – 12:30 PM

The Endpoints for Transcatheter Aortic Valve Development
– Ori Ben-Yehuda 

12:30 – 12:50 PM

Panel Discussion:
– Stan Rowe, Jeroen Bax, Seth Clancy, Bernard Vassuer, Bram Zuckerman, Robert Bonow, Ian Meredith, Susan Strong

Session IV – Translational Pathway for Transcatheter Mitral/Tricuspid Valves

Moderators: Robert Bonow, John Laschinger

12:50 – 1:05 PM

The Methods for Transcatheter Mitral/Tricuspid Valve Development
– Michael Mack 

1:05 – 1:20 PM

The Endpoints for Transcatheter Mitral/Tricuspid Valve Development
Blase Carabello

1:20 – 1:40 PM

Panel Discussion:
– Michael Mack, Blasé Carabello, Gregg Stone, Patrick Verta, Changfu Wu, Sharon Saeger, Robert Thatcher, Steve Goldberg, David Reuter, Wade Aubry

Session V – Translational Pathway for Coronary Stents
Moderators:  Gregg Stone, Mitchell Krucoff

1:40 – 1:55 PM

The Methods for Coronary Stent Development
– Charles Simonton 

1:55 – 2:10 PM

The Endpoints for Coronary Stent Development
– Donald Cutlip 

2:10 – 2:30 PM

Panel Discussion:
Donald Cutlip, Neal  Fearnot, Andrew Farb, Spencer King, Ian Meredith, Laura Perkins, Robert Benton

2:30 – 2:45 PM


Session VI – Translational Pathway for Catheter Ablation
Moderators:  Douglas Packer, Marco Cannella

2:45 – 3:00 PM

The Methods for Catheter Ablation Development
– Douglas Packer 

3:00 – 3:15 PM

The Endpoints for Catheter Ablation Development
– Marco Cannella 

3:15 – 3:35 PM

Panel Discussion:
– Wade Aubry, Tonya Dowd, Jun Dong, Timothy Laske, Larry Haffner, Amit Shanker

Session VII – Translational Pathway for Left Ventricular Assist Devices
Moderators:  lleana Piña, Magdi Yacoub

3:35 – 3:50 PM

The Methods for LVAD Development
– Francis Pagani 

3:50 – 4:05 PM

The Endpoints for LVAD Evaluation
Keith Aaronson 

4:05 – 4:25 PM

Panel Discussion:
– Francis Pagani, Keith Aaronson, Phil Adamson, Changfu Wu, Michael Minogue, Bernard Vassuer 

Session VIII – Application of the Translational Pathway for Cardiovascular Devices

Moderators: Bram Zuckerman, Spencer King

4:25 – 5:00 PM

Panel Discussion:
– Lori Ashby, Andrew Farb, Stan Rowe, Alice Jacobs, Charles Simonton, Roseann White, Chris Mullin, Blasé Carabello, Douglas Packer, Keith Aaronson, Jeroen Bax

Chair of the Cardiovascular Governance Council at Baylor Scott & White Health

ISCTR-TCT 2018 Meeting Speakers

Keith Aaronson, MD

Professor of Medicine
Michigan Medicine, University of Michigan

Phil Adamson, MD

Divisional VP, Medical Director, Global Clinical Research and Development
Abbott Vascular

Lori Ashby

Director, Division of Policy and Evidence Review, Coverage and Analysis Group, Center for Clinical Standards and Quality, CMS

Wade Aubry, MD

Professor of Medicine
UC San Francisco

Jeroen Bax, MD

European Society of Cardiology

Robert Benton

Patient, ISCTR

Ori Ben-Yehuda, MD

Executive Director, Clinical Trial Center
Cardiovascular Research Foundation

Robert Bonow, MD

Northwestern University

Marco Cannella, Ph.D.

Senior Lead Reviewer
Cardiac Electrophysiology Devices Branch, FDA

Blasé Carabello, MD

Chief of Cardiology, Brody School of Medicine at East Carolina University and Vidant Medical Center

Seth Clancy

Senior Director, Global Health Economics and Reimbursement, Edward Lifesciences

Alain Cribier, MD

Professor of Medicine and Director of Cardiology at the University of Rouen, Charles Nicolle Hospital

Donald Cutlip, MD

Beth Israel-Deaconess

Nabil Dib, MD

President, ISCTR
Director of Cardiovascular Research, Mercy Gilbert Medical Center, Gilbert, AZ

Jun Dong, MD, PhD

Medical Officer, Cardiac Electrophysiology Devices Branch, FDA

Tonya Dowd

Director, Franchise Health Economics and Market Access, Cardiovascular and Specialty Solutions
Johnson & Johnson Medical Device Companies

Andrew Farb, MD

Medical Officer, Interventional Cardiology Devices Branch, FDA

Neal Fearnot, PhD

Vice President, Cook Group, Inc.

Steve Goldberg, MD

Chief Medical Officer
Cardiac Dimensions

Larry Haffner

Patient, ISCTR

Alice Jacobs, MD

Vice Chair, Clinical Affairs at The Cardiovascular Center, Boston University

Louis Jacques, MD

Chief Clinical Office, Advi

Michael John, MPH

Branch Chief, Circulatory Support Devices Branch, FDA

Spencer King, MD

Professor Emeritus of Medicine, Emory University

Mitchell Krucoff, MD

Professor of Medicine, Duke Clinical Research Institute

John Laschinger, MD

Medical Officer, Structural Heart Device Branch, FDA

Timothy Laske, PhD

Vice President of Research and Business Development – Medtronic AF Solutions

Martin Leon, MD

Professor of Medicine at Columbia University Medical Center

Michael Mack, MD

Chair of the Cardiovascular Governance Council at Baylor Scott & White Health

Mark Mercola, PhD

Professor of Medicine, Stanford Cardiovascular Institute

Ian Meredith, MD

Global Chief Medical Officer & Executive VP, Boston Scientific

Michael Minogue

CEO, Abiomed

Chris Mullin

Director, Product Development Strategy, NAMSA

Douglas Packer, MD

Mayo Clinic

Francis Pagani, MD

Surgical Director of the Adult Heart Transplant Program and Program Director for the Center for Circulatory Support at University of Michigan

Laura Perkins, DVM, PhD

Abbott Vascular

lleana Piña, MD, MHP

Professor, Department of Medicine
Montefiore Medical Center

David Reuter, MD

Director, Cardiac Innovation, Seattle Children’s Hospital

Robert Roberts, MD

Professor of Cardiology, University of Arizona College of Medicine

Stanton Rowe

Chief Medical Officer, Edwards Lifesciences

Sharon Saeger

Patient, ISCTR

Amit J. Shanker, MD

Senior Vice President and Chief Medical Officer, Terumo Medical Corporation

Charles Simonton, MD

Chief Scientific Officer, Cardiac Therapies, Abbott Vascular

Gregg Stone, MD

Director of Cardiovascular Research and Education
Columbia University Medical Center/New York Presbyterian Hospital

Susan Strong

Patient, ISCTR

Robert Thatcher

President and CEO, 4C Medical Technologies

Bernard Vasseur, MD

Medical Officer, Cardiology, FDA

Patrick Verta, MS, DVM, MD

VP, Global Medical Affairs, Clinical Science and Biometrics
Edward Lifesciences

Roseann White, PhD

Director of Pragmatic Clinical Trials, Duke Clinical Research Institute

Changfu Wu, PhD

Mechanical Engineer, Structural Heart Device Branch, FDA

Magdi Yacoub, MD, FRS, OM

Imperial College, London
Aswan Heart Center
Harefield Heart Science Center

Bram Zuckerman, MD

Director, FDA Division of Cardiovascular Devices, FDA

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