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OCTOBER 29-NOVEMBER 2, 2017
COLORADO CONVENTION CENTER
DENVER, COLORADO

Satellite programs offer sponsors the opportunity to provide professional attendees with comprehensive insights into important interventional topics and issues facing today's specialists. The satellite program schedule is comprised of Breakfast Meetings, Presentation Theater Programs (lunch sessions), and Evening Programs.

 

Satellite Programs

The Translational Pathways for Cardiovascular Devices; Current and Future Direction

Special Session

10/29/2016 07:00:00 10/29/2016 17:00:00 The Translational Pathways for Cardiovascular Devices; Current and Future Direction TCT 2017 true MM/DD/YYYY TCT 2014 Satellite Symposia - Special Session

Saturday, October 29, 2016
Program: 7:00 am-5:00 pm
Walter E. Washington Convention Center, Washington, D.C., Room 146A, Lower Level

The Translational Pathways for Cardiovascular Devices; Current and Future Direction

The Translational Pathways for Cardiovascular Devices; Current and Future Direction

Sponsored by International Society for Cardiovascular Translational Research

Faculty  

Dorothy Abel, BSBME

FDA

Silver Spring, MD

 

Karim Benali, MD

Abiomed

Boston, MA

 

Robert M. Califf, MD

FDA Commissioner

Silver Spring, Maryland

 

Deborah Castillo, PhD

FDA

Silver Spring, MD

 

Judith Davis, DVM, MS

FDA

Silver Spring, MD

 

Anthony DeMaria, MD

ISCTR

La Jolla, AZ

 

Nabil Dib, MD, MSc

ISCTR

Phoenix, AZ

 

Jun Dong, MD

FDA

Silver Spring, MD

 

Andrew Farb, MD

FDA

Silver Spring, MD

 

Neal Fearnot, PhD

Cook Group

Lafayette, IN

 

Mark Fellman, BME

FDA

Silver Spring, MD

 

Nicole Ibraham, PhD

FDA

Silver Spring, MD

 

Alice Jacobs, MD

Boston Medical Center

Boston, MA

 

Michael John, MPH

FDA

Silver Spring, MD

 

Spencer B. King, MD

Emory Helathcare

Atlanta, GA

 

Mitchell Krucoff, MD

Duke University Medical Center

Chapel Hill, NC

 

John Laschinger, MD

FDA

Silver Spring, MD

 

Timothy Laske, PhD

Medtronic

Minneapolis, MN

 

Martin B. Leon, MD

NewYork Presbyterian Hospital/Columbia University Medical Center

New York, NY

 

Jack Lewin, MD

CRF

New York, NY

 

Michael Mack, MD

Baylor

Dallas, TX

 

Rick McGuire

Health & Medical Multimedia

Phoenix, AZ

 

James Muller, MD

Massachusetts General Hospital

Boston, MA

 

Douglas Packer, MD

Mayo Clinic

Rochester, MN

 

Laura Perkins, DVM

Abbott Vascular

Richmond, VA

 

Bradley Quinn, BME

FDA

Siver Spring, MD

 

Richard Rapoza, PhD

Abbott Vascular

San Francisco, CA

 

David Reuter, MD

Seattle Children's Hospital

Seattle, WA

 

Robert Roberts, MD

ISCTR

Phoenix, AZ

 

Stanton Rowe

Edwards Lifesciences

Orange County, CA

 

Win-Kuang Shen, MD

Mayo Clinic

Rochester, MN

 

Charles Simonton, MD

Abbott Vascular

San Francisco, CA

 

Andy Slavitt

CMS

Baltimore, MD

 

Gregg W. Stone, MD

NewYork Presbyterian Hospital/Columbia University Medical Center

New York, NY

 

Craig Thompson, MD

Boston Scientific

Natick, MA

 

Patricia Todd

Edwards Lifesciences

Orange County, CA

 

Mark Toland

Corindus

Waltham, MA

 

Renu Virmani, MD

CV Path

Gaithersburg, MD

 

Roseann White, MA

Duke Clinical Research Institute

Raleigh-Durham, NC

 

Uri Yaron, PhD, M&A

Johnson & Johnson

Los Angeles, CA

 

Bram D. Zuckerman, MD

FDA

Silver Spring, Maryland

Agenda

Introduction

7:00 am

Welcome Statement

Nabil Dib, Martin B. Leon

Session I - Basic Process for Device Development

7:05 am

ISCTR Mission and Statement of Meeting Purpose

Nabil Dib

7:20 am

Requirement for New Technology to be Included in the Guideline, "The Ultimate Goal"

Alice Jacobs

7:35 am

CMS Criteria for Reimbursement of Cardiovascular Innovation

Andy Slavitt

7:50 am

Regulatory Requirement for Marketing Approval

Deborah Castillo

8:05 am

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

Roseann White

8:20 am

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

Mitchell Krucoff

8:35 am

Basic Process for Device Development Panel Discussion

Moderators : Jack Lewin, Bram D. Zuckerman

Discussants : Deborah Castillo, Anthony DeMaria, Nabil Dib, Alice Jacobs, Spencer B. King, Mitchell Krucoff, Martin B. Leon, Jack Lewin, Robert Roberts, Stanton Rowe, Roseann White, Bram D. Zuckerman

9:00 am

Break

Session II - Pre-Clinical Early Feasibility and Safety Study for Device Development

9:15 am

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

Andrew Farb

9:30 am

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

Karim Benali

9:45 am

Requirments for Medical Device Manufacturing and Iteration; Industry Point of View

Richard Rapoza

10:00 am

Requirements for Medical Device Manufacturing and Iteration; FDA Point of View

Bradley Quinn

10:15 am

Optimal Pre-Clinical Study Design and Endpoints for Device Evaluation; Investigator Point of View

Renu Virmani

10:30 am

Optimal Pre-Clinical Study Design and Enpoints for Device Evaluation; FDA Point of View

Judith Davis

10:45 am

Pre-Clinical Early Feasibility and Safety Study for Device Development Panel Discussion

Moderators : Andrew Farb, David Reuter

Discussants : Karim Benali, Judith Davis, Andrew Farb, James Muller, Laura Perkins, Bradley Quinn, Richard Rapoza, David Reuter, Patricia Todd, Renu Virmani, Roseann White

11:00 am

Lunch

11:20 am

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

Anthony DeMaria

Keynote Speaker

11:30 am

The Translational Pathway to Expedite Scientific Discovery to Patients

Robert M. Califf

Session III - Aortic Valve Development

12:00 pm

The Clinical Need for Innovative Treatment for Aortic Valve Disease

Martin B. Leon

12:15 pm

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

Stanton Rowe

12:30 pm

Current Challenges and Future Direction for Aortic Valve Development and Iteration; FDA Point of View

Nicole Ibraham

12:45 pm

Aortic Valve Development Panel Discussion

Moderators : Martin B. Leon, Stanton Rowe

Discussants : Nicole Ibraham, Spencer B. King, Martin B. Leon, Michael Mack, Stanton Rowe, Patricia Todd, Renu Virmani, Bram D. Zuckerman

Session IV - Mitral/Tricuspid Valve Development

1:00 pm

The Clinical Need for Innovative Treatment for Mitral/Tricuspid Valve Disease

Michael Mack

1:15 pm

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

Patricia Todd

1:30 pm

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

John Laschinger

1:45 pm

Mitral/Tricuspid Valve Development Panel Discussion

Moderators : Dorothy Abel, Gregg W. Stone

Discussants : Dorothy Abel, John Laschinger, Martin B. Leon, Michael Mack, Gregg W. Stone, Patricia Todd, Renu Virmani

Session V - Coronary Stent Development

2:00 pm

The Clinical Need for Innovative Coronary Stent

Gregg W. Stone

2:15 pm

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

Charles Simonton

2:30 pm

Current Challeges and Future Direction for Coronary Stent Development and Iteration; FDA Point of View

Moderator : Michael John

2:45 pm

Coronary Stent Development Panel Discussion

Moderators : Spencer B. King, Gregg W. Stone

Discussants : Neal Fearnot, Michael John, Spencer B. King, Charles Simonton, Gregg W. Stone, Craig Thompson, Mark Toland, Renu Virmani

3:00 pm

Break

Session VI - Catheter Ablation Development

3:10 pm

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

Douglas Packer

3:25 pm

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

Uri Yaron

3:40 pm

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

Jun Dong, Mark Fellman

3:55 pm

Catheter Ablation Development Panel Discussion

Moderators : Mark Fellman, Douglas Packer

Discussants : Anthony DeMaria, Jun Dong, Mark Fellman, Timothy Laske, Douglas Packer, Win-Kuang Shen, Renu Virmani, Uri Yaron

Session VII - Consensus Document

4:15 pm

Writing a Consensus Document

Anthony DeMaria

4:30 pm

Writing a Consensus Document Panel Discussion

Moderators : Anthony DeMaria, Spencer B. King

Discussants : Anthony DeMaria, Nabil Dib, Andrew Farb, Spencer B. King, Mitchell Krucoff, Martin B. Leon, Jack Lewin, Rick McGuire, James Muller, Robert Roberts, Stanton Rowe, Charles Simonton, Renu Virmani, Roseann White, Bram D. Zuckerman

5:00 pm

Adjourn