2016 Consensus Summit

ISCTR Consensus Summit

Saturday, October 29, 2016

Walter E. Washington Convention Center, Room 146A

Washington, DC

7:00 am – 5:00 pm

Objective: To develop a consensus document for a translational pathway for future cardiovascular device development that incorporates industry, FDA, and CMS input for cardiovascular disease (valvular disease, coronary artery disease, arrhythmia, and heart failure)

Introduction

Welcome

Nabil Dib, Martin Leon

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

Anthony N. DeMaria

Keynote Address: The Translational Pathway to Expedite Scientific Discovery to Patients

Robert Califf

Basic Process for Device Development

Moderators: Bram Zuckerman, Jack Lewin

ISCTR Mission And Statement of Meeting Purpose

Nabil Dib

Requirement for New Technology to be Included in the Guidelines, “The Ultimate Goal”

Alice Jacobs

CMS Criteria For Reimbursement Of Cardiovascular Innovation

Andy Slavitt (invited)

Regulatory Requirement for Marketing Approval

Deborah Castillo

Pre-Clinical and Clinical Trial Design and Endpoints of Fast Track to Device Approval

Roseann White

A Unified Approach for Clinical Trial Design That Meets The Requirement of Regulatory Approval, Reimbursement And The Clinical Practice Guideline

Mitchell Krucoff

Pre-Clinical, Early Feasibility, and Safety Study for Device Development

Moderators: Andrew Farb, David Reuter

Requirements for Medical Device Manufacturing And Iteration: Industry Point of View

Richard Rapoza

Requirements for Medical Device Manufacturing And Iteration: FDA Point of View

Brad Quinn

Optimal Pre-Clinical Study Design and Endpoints for Device Evaluation: Investigator Point Of View

Renu Virmani

Optimal Pre-Clinical Study Design and Endpoints for Device Evaluation: FDA Point Of View

Judith Davis

Current Challenges and Future Direction for Feasibility and Early Human Study for Device Evaluation: FDA Point of View

Andrew Farb

Current Challenges and Future Direction for Feasibility and Early Human Study for Device Evaluation: Industry Point of View

Karim Benali

Aortic Valve Development

Moderators: Martin Leon, Stan Rowe

The Clinical Need for Innovative Treatment for Aortic Valve Disease

Martin Leon

Current Challenges and Future Direction for Aortic Valve Development and Iteration: Industry Point of View

Stanton Rowe

Current Challenges and Future Direction for Aortic Valve Development and Iteration: FDA Point Of View

Nicole Ibraham

Mitral/Tricuspid Valve Development

Moderators: Gregg Stone, Dorothy Abel

The Clinical Need for innovative treatment for Mitral/Tricuspid Valve Disease

Michael Mack

Current Challenges and Future Direction for Mitral/Tricuspid Valve Development And Iteration: Industry Point of View

Patricia Todd

Current Challenges and Future Direction for Mitral/Tricuspid Valve Development and Iteration: FDA Point of View

John Laschinger

Coronary Stent Development

Moderators: Neal Fearnot, Spencer King

The Clinical Need for Innovative Coronary Stent

Gregg Stone

Current Challenges and Future Direction for Coronary Stent Development and Iteration: Industry Point of View

Charles Simonton

Current Challenges and Future Direction for Coronary Stent Development and Iteration: FDA Point of View

Michael John

Catheter Ablation Development

Moderators: Douglas Packer, Mark Fellman

The Clinical Need for the Treatment of Arrhythmia, Innovative Catheter Ablation

Douglas Packer

Current Challenges and Future Direction for Catheter Ablation Development and Iteration: Industry Point of View

Uri Yaron

Current Challenges and Future Direction for Catheter Ablation Development and Iteration: FDA Point of View

Jun Dong, Mark Fellman

Consensus Document

Writing Consensus Document

Anthony DeMaria

Panel discussions will conclude each session.