2018 Consensus Summit

ISCTR – TCT 2018 Consensus Summit

Consensus Summit on Translational Pathways for Cardiovascular Devices

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

 

Objective

To present and discuss the final consensus on translational pathways for cardiovascular device development and iteration for cardiovascular diseases (valvular disease, coronary artery disease, arrhythmia, and heart failure) that incorporates input from academia, industry, the FDA, and payers

Introduction

Welcome and ISCTR Mission Statement and Introduction

Spencer King, Nabil Dib

Requirements for CV Device Approval: Regulatory, Payers, and Practice Guidelines

Moderators: Bram Zuckerman, David Holmes

Regulatory Requirement for Marketing Approval

Bram Zuckerman

CMS Requirement for Reimbursement for Innovation

Joseph Chin

Practice Guidelines Requirement for New Technology

Alice Jacobs

Preclinical and Clinical Trial Design and Endpoints for Device Approval

Roseann White, Chris Mullin 

Early Feasibility Studies for Device Evaluation

Andrew Farb

The Patient’s Voice

Mark Marcola

Award Presentation and Keynote Address

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

Marilyn Nelson, Stan Rowe, Robert Bonow

Keynote Address: The TAVR Development from Concept to First in Man

Alain Cribier, Nelson Award Recipient

Keynote Address: The TAVR Development from First in Man to Phase III and  Beyond

Martin Leon, Nelson Award Recipient

Translational Pathway for Aortic Valve Development

Moderators: Martin Leon, Jeroen Bax

The Methods for Aortic Valve Development

Stan Rowe

The Endpoints for Aortic Valve Development

Ori Ben-Yehuda

Translational Pathway for Mitral/Tricuspid Valve Development

Moderators: Robert Bonow, John Laschinger

The Methods for Mitral/Tricuspid Valve Development

Michael Mack

The Endpoints for Mitral/Tricuspid Valve Development

Blasé Carabello

Translational Pathway for Coronary Stent Development

Moderators: Gregg Stone, Mitchell Krucoff

The Methods for Coronary Stent Development

Charles Simonton

The Endpoints for Coronary Stent Development

Donald Cutlip

Translational Pathway for Catheter Development

Moderators: Douglas Packer, Mark Fellman

The Methods for Catheter Ablation Development

Douglas Packer

The Endpoints for Catheter Ablation Development

Marco Canella

Translational Pathway for Left Ventricular Assist Device Development

Moderators: lleana Piña, Magdi Yacoub

The Methods for LVAD Development

Francis Pagani

The Endpoints for LVAD Development

Keith Aaronson

Consensus Document

Moderators: Bram Zuckerman, Spencer King

Discussants: Joseph Chin, Andrew Farb, Stan Rowe, Alice Jacobs, Charles Simonton, Roseann White, Chris Mullin, Blasé Carabello, Douglas Packer, Keith Aaronson, Anthony DeMaria, Jeroen Bax

Panel discussions will conclude each session.