2016 Consensus Summit

ISCTR Consensus Summit

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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, Spencer King

ISCTR Mission and Statement of Meeting Purpose

Nabil Dib

Basic Process for Device Development

Moderators: Bram Zuckerman, Jack Lewin

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

Alice Jacobs

CMS Criteria For Reimbursement Of Cardiovascular Innovation

Joseph Chin

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

Panel Discussion

Bram Zuckerman, Jack Lewin, Nabil Dib, Alice Jacobs, Joseph Chin, Deborah Castillo, Roseann White, Mitchell Krucoff, Robert Roberts, Anthony DeMaria, Stan Rowe, Charles Simonton, Spencer King, Ron Waksman

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

Moderators: Andrew Farb, David Reuter

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

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

Panel Discussion

Andrew Farb, David Reuter, Michael Minogue, Richard Rapoza, Brad Quinn, Renu Virmani, Judith Davis, Laura Perkins, Roseann White, James Muller, Patricia Todd, Robert Kohler

Lunch and Keynote Address

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

Anthony N. DeMaria and Marilyn Nelson

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

Robert Califf

Aortic Valve Development

Moderators: Spencer King, 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

Panel Discussion

Stan Rowe, Nicole Ibraham, Michael Mack, Renu Virmani, Patricia Todd, Bram Zuckerman, Spencer King

Mitral/Tricuspid Valve Development

Moderators: Gregg Stone, Changfu Wu

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

Panel Discussion

Gregg Stone, Changfu Wu, Patricia Todd, John Laschinger, Renu Virmani, Michael Mack

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: FDA Point of View

Michael John

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

Charles Simonton

Panel Discussion

Spencer King, Michael John, Charles Simonton, Neal Fearnot, Mark Toland, Gregg Stone, Craig Thompson

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

Mark Fellman

Panel Discussion

Douglas Packer, Uri Yaron, Jun Dong, Mark Fellman, Anthony DeMaria, Timothy Laske, Win-Kuang Shen, Mark Carlson

Consensus Document

Writing Consensus Document

Anthony DeMaria

Panel Discussion

Anthony DeMaria, Spencer King, Bram Zuckerman, Jack Lewin, Robert Roberts, Andrew Farb, Stan Rowe, Charles Simonton, Rick McGuire, Roseann White, Nabil Dib, James Muller