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Translational Pathways for Cardiovascular Devices

Special Session

09/21/2018 08:00:00 09/21/2018 17:00:00 Translational Pathways for Cardiovascular Devices TCT 2017 true MM/DD/YYYY TCT 2014 Satellite Symposia - Special Session

Friday, September 21, 2018
Program: 8:00 am-5:00 pm
San Diego Convention Center, 30A-C

Translational Pathways for Cardiovascular Devices

Translational Pathways for Cardiovascular Devices

Sponsored by International Society for Cardiovascular Translational Research

Chairs  

Nabil Dib, MD

ISCTR

Phoenix, AZ

 

Spencer King, MD

Emory

Atlanta, GA

 

Martin Leon, MD

CRF

New York, NY

 

Bram Zuckerman, MD

FDA

Silver Springs, MD

Faculty  

Keith Aaronson, MD

University of Michigan

Ann Arbor, MI

 

Phil Adamson, MD

Abbott

Austin, TX

 

Lori Ashby

CMS

Washington, DC

 

Wade Aubry, MD

St Francis Memorial Hospital

San Francisco, CA

 

Jeroen Bax, MD

Leiden University Medical Center

Leiden, Netherlands

 

Ori Ben-Yehuda, MD

CRF

New York, NY

 

Robert Benton

ISCTR

Phoenix, AZ

 

Robert Bonow, MD

Northwestern University

Chicago, IL

 

Robin Bostic

Abbott

Boston, MA

 

Kevin Bourque, MS

Abbott

Boston, MA

 

Marco Cannella, PhD

FDA

Silver Spring, MD

 

Daniel Caños

CMS

Washington, DC

 

Blase Carabello, MD

MED VA Medical Center

Houston, TX

 

Mark Carlson, MD

Abbott

Los Angeles, CA

 

Alain Cribier, MD

University of Rouen's Charles Nicolle Hospital

Rouen, France

 

Donald Cutlip, MD

Beth Israel Deaconess

Boston, MA

 

Nabil Dib, MD

ISCTR

Phoenix, AZ

 

Jun Dong, PhD

FDA

Silver Spring, MD

 

Andrew Farb, MD

FDA

Silver Spring, MD

 

Neal Fearnot

COOK Medical

Bloomington, IN

 

Steve Goldberg, MD

Cardiac Dimensions

Kalispell, MT

 

Larry Haffner

ISCTR

Phoenix, AZ

 

Anthony Hong, MBA

Johnson & Johnson

Orange County, CA

 

Nicole Ibrahim, PhD

FDA

Silver Spring, MD

 

Alice Jacobs, MD

Boston University

Boston, MA

 

Louis Jacques, MD

Advi Health

Washington, DC

 

Michael John, MPH

FDA

Silver Spring, MD

 

Spencer King, MD

Emory

Atlanta, GA

 

Mitchell Krucoff, MD

Duke University

Raleigh-Durham, NC

 

John Laschinger, MD

FDA

Silver Spring, MD

 

Timothy Laske, PhD

Medtronic

Minneapolis, MN

 

Michael Mack, MD

Baylor University

Dallas, TX

 

Mark Mercola, PhD

Stanford University

Palo Alto, CA

 

Ian Meredith, MD

Boston Scientific

Boston, MA

 

Michael Minogue

Abiomed

Boston, MA

 

Chris Mullin

NAMSA

St Paul, AZ

 

Douglas Packer, MD

Mayo Clinic

Rochester , MN

 

Francis Pagani MD, MD

University of Michigan

Ann Arbor, MI

 

Laura Perkins, DVM

Abbott

Richmond, VA

 

Ileana Piña, MD

Montefiore Medical Center

New York, NY

 

David Reuter, MD

Seattle Children's Hospital

Seattle, WA

 

Stan Rowe

Edwards Lifesciences

Irvine, CA

 

Sharon Saeger

ISCTR

Phoenix, AZ

 

Amit Shanker, MD

Terumo Medical

Somerset, NJ

 

Charles Simonton, MD

Abbott

San Francisco, CA

 

Gregg Stone, MD

CRF

New York, NY

 

Susan Strong

ISCTR

Phoenix, AZ

 

Robert Thatcher

4C Medical Technologies

Minneapolis, MN

 

Patrick Verta, DVM

Edwards Lifesciences

Irvine, CA

 

Roseann White, MA

Duke University

Raleigh-Durham, NC

 

Changfu Wu

FDA

Silver Spring, MD

 

Magdi Yacoub, MD

Imperial College

London, England

 

Bram Zuckerman, MD

FDA

Silver Spring, MD

Agenda

Introduction

8:00 am

Welcome Statement

Spencer King

8:05 am

ISCTR Mission and Statement of Meeting Purpose

Nabil Dib

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

8:20 am

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

Bram Zuckerman

8:35 am

CMS Requirement for Reimbursement for Innovation

Lori Ashby

8:50 am

Practice Guidelines Requirement for New Technology

Alice Jacobs

9:05 am

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

Chris Mullin, Roseann White

9:20 am

Early Feasibility Studies for Device Evaluation

Andrew Farb

9:35 am

The Patients Voice

Mark Mercola

9:45 am

Requirements for CV Devices Approval; Regulatory, Payers, and Practice Guidelines Panel Discussion

Moderator : Bram Zuckerman

Discussants : Phil Adamson, Lori Ashby, Robert Bonow, Andrew Farb, Alice Jacobs, Louis Jacques, Spencer King, Mitchell Krucoff, Mark Mercola, Chris Mullin, David Reuter, Stan Rowe, Charles Simonton, Roseann White

10:15 am

Break

Session II: ISCTR Award Presentation and Keynote Address

10:30 am

Presentation of the Glen and Marilyn Nelson Award for Innovation and Translation in Cardiovascular Medicine to Alain Cribier and Martin Leon

Robert Bonow, Stan Rowe

10:40 am

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

10:45 am

The TAVR Development from Concept to First in Man

Alain Cribier

11:05 am

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

Martin Leon

11:25 am

Lunch Break

Session III: Translational Pathway for Aortic Valve Development

12:00 pm

The Methods for Aortic Valve Development

Stan Rowe

12:15 pm

The Endpoints for Aortic Valve Development

Ori Ben-Yehuda

12:30 pm

Translational Pathway for Aortic Valve Panel Discussion

Moderators : Jeroen Bax, Martin Leon

Discussants : Jeroen Bax, Robert Bonow, Nicole Ibrahim, Ian Meredith, Stan Rowe, Susan Strong, Bram Zuckerman

Session IV: The Translational Pathway for Mitral/Tricuspid Valve Development

12:50 pm

The Methods for Mitral/Tricuspid Valve Development

Michael Mack

1:05 pm

The Endpoints for Mitral/Tricuspid Valve Development

Blase Carabello

1:20 pm

The Translational Pathway for Mitral/Tricuspid Valve

Moderators : Robert Bonow, John Laschinger

Discussants : Wade Aubry, Blase Carabello, Steve Goldberg, Michael Mack, David Reuter, Sharon Saeger, Gregg Stone, Robert Thatcher, Patrick Verta, Changfu Wu

Session V: The Translational Pathway for Coronary Stent Development

1:40 pm

The Methods for Coronary Stent Development

Charles Simonton

1:55 pm

The Endpoints for Coronary Stent Development

Donald Cutlip

2:10 pm

The Translational Pathway for Coronary Stent Panel Discussion

Moderators : Mitchell Krucoff, Gregg Stone

Discussants : Robert Benton, Donald Cutlip, Neal Fearnot, Michael John, Spencer King, Ian Meredith, Laura Perkins, Charles Simonton

2:30 pm

Break

Session VI: The Translational Pathway for Catheter Ablation Development

2:45 pm

The Methods for Catheter Ablation Development

Douglas Packer

3:00 pm

The Endpoints for Catheter Ablation Development

Marco Cannella

3:15 pm

The Translational Pathway for Catheter Ablation Panel Discussion

Moderators : Marco Cannella, Douglas Packer

Discussants : Wade Aubry, Mark Carlson, Jun Dong, Larry Haffner, Anthony Hong, Timothy Laske, Amit Shanker

Session VII: The Translational Pathway for Left Ventricular Assist Device Development

3:35 pm

The Methods for LVAD Development

Francis Pagani MD

3:50 pm

The Endpoints for LVAD Evaluation

Keith Aaronson

4:05 pm

The Translational Pathway for Left Ventricular Assist Devices Panel Discussion

Moderators : Ileana Piña, Magdi Yacoub

Discussants : Keith Aaronson, Phil Adamson, Robin Bostic, Mark Carlson, Michael Minogue, Francis Pagani MD, Changfu Wu

Session VIII: Application of the Consensus Document

4:25 pm

Application of the Consensus Document Panel Discussion

Moderator : Bram Zuckerman

Discussants : Keith Aaronson, Lori Ashby, Jeroen Bax, Blase Carabello, Andrew Farb, Alice Jacobs, Chris Mullin, Douglas Packer, Stan Rowe, Roseann White

5:00 pm

Adjourn