PROGRAM

TCT 2019 will feature a host of sponsored satellite programs offering attendees comprehensive insights into important interventional topics and issues facing interventional specialists. 

Sponsored sessions include breakfast programs, lunchtime Presentation Theater programs, and evening programming. 

Satellite Programs

Translational Pathways for Cardiovascular Devices

Special Session

09/25/2019 08:00:00 09/25/2019 17:00:00 Translational Pathways for Cardiovascular Devices TCT 2017 true MM/DD/YYYY TCT 2014 Satellite Symposia - Special Session

Wednesday, September 25, 2019
Check-in: 7:15 am  | 
Program: 8:00 am-5:00 pm
The Moscone Center, Room 151/153, Mezzanine Level, Moscone South

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 III, MD

Emory University

Atlanta, GA

 

Martin Leon, MD

CRF

New York, NY

 

Bram Zuckerman, MD

FDA

Silver Spring, MD

Faculty  

William Abraham, MD

Ohio State University

Columbus, OH

 

Fernando Aguel

FDA

Silver Spring, MD

 

Lori Ashby

Centers for Medicare and Medicaid Services

Baltimore, MD

 

Jeroen Bax, MD

University of Leiden

Leiden, Netherlands

 

Daniel Berman, MD

Cedars-Sinai Medical Center

Los Angeles, CA

 

Seth Bilazarian, MD

Abiomed

Boston, MA

 

Tobias Bohling

Siemens Healthineers

Sunnyvale, CA

 

Robert Bonow, MD

Northwestern University

Chicago, IL

 

Todd Brinton, MD

Edwards Lifesciences

Irvine, CA

 

Robert Byrne, MD

Klinik für Herz und Kreislauferkrankungen

Lazarettstraße, Germany

 

Marco Cannella, PhD

FDA

Silver Spring, MD

 

Joseph Chin, MD

CMS

Washington, DC

 

Seth Clancy

Edward Lifesciences

Irvine, CA

 

Carlos Collet, MD

OLV Ziekenhuis Aalst-Asse-Ninove Health Care

Brussels, Belgium

 

Alain Cribier, MD

University of Rouen

Rouen, France

 

Kevin Croce, MD

Harvard Medical School

Boston, MA

 

Anthony DeMaria, MD

University of California San Diego

San Diego, CA

 

Nabil Dib, MD

ISCTR

Phoenix, AZ

 

Tonya Dowd

Johnson & Johnson

Orange County, CA

 

Ryan Egeland, MD

Cardiovascular Systems, Inc.

St. Paul, MN

 

Andrew Farb, MD

FDA

Silver Spring, MD

 

Neal Fearnot, PhD

Cook Group, Inc.

Bloomington, IN

 

Avi Fischer, MD

Abbott Cardiac Rhythm

New York, NY

 

Peter Fitzgerald, MD

Stanford University Medical Center

Palo Alto, CA

 

Shawn Forrest

FDA

Silver Spring, MD

 

Alan Fraser, MD

Cardiff University

Wales, United Kingdom

 

Lydia Glaw, PhD

FDA

Silver Spring, MD

 

Steven Goldberg, MD

Cardiac Dimensions

Kirkland, WA

 

Rebecca Hahn, MD

NewYork-Presbyterian/ Columbia University Medical Center

New York, NY

 

David Holmes Jr., MD

Mayo Clinic

Minneapolis, MN

 

Nicole Ibrahim

FDA

Silver Spring, MD

 

James Inskeep, Esq

Inskeep Intellectual Property Group

Torrance, CA

 

Louis Jacques, MD

ADVI

Washington, DC

 

David Kandzari, MD

Piedmont Heart Institute

Atlanta, GA

 

Navin Kapur, MD

Tufts Medical Center

Boston, MA

 

Morton Kern, MD

VA Long Beach Health Care System School of Medicine

Long Beach, CA

 

Spencer King III, MD

Emory University

Atlanta, GA

 

Ajay Kirtane, MD

Columbia University Medical Center

New York, NY

 

Mitchell Krucoff, MD

Duke Clinical Research Institute

Durham, NC

 

Martin Leon, MD

CRF

New York, NY

 

Adrian Magee, MD

FDA

Silver Spring, MD

 

Roxana Mehran, MD

Icahn School of Medicine at Mount Sinai

New York, NY

 

Ian Meredith, MD

Boston Scientific

Marlborough, MA

 

James Min, MD

New York Presbyterian Hospital

New York, NY

 

James E. Muller, MD

InfraReDx, Inc.

Burlington, MA

 

Chris Mullin, MS

NAMSA

Minneapolis, MN

 

Jaime Murillo, MD

United Healthcare

Fort Lauderdale, FL

 

Diana Nelson

ISCTR

Phoenix, AZ

 

Rachel Neubrander

FDA

Silver Spring, MD

 

William O'Neill, MD

Henry Ford Medical Group

Detroit, MI

 

Julio Palmaz, MD

Co-inventor of the Palmaz-Schatz Stent

San Francisco, CA

 

Christopher Panarites, PhD

Abbott

San Francisco, CA

 

Manesh Patel, MD

Duke University

Durham, NC

 

Ileana Piña, MD

Montefiore Medical Center

Bronx, NY

 

Mark Reisman, MD

University of Washington Medical Center

Seattle, WA

 

David Reuter, MD

Seattle Children's Hospital

Kirkland, WA

 

Rhonda Robb

Cardiovascular Systems, Inc.

St. Paul, MN

 

Robert Roberts, MD

ISCTR

Phoenix, AZ

 

Campbell Rogers, MD

Heartflow, Inc.

Portola Valley, CA

 

Gary Roubin, MD

Brookwood Baptist Health

Birmingham, AL

 

Stanton Rowe

NXT Biomedical

Irvine, CA

 

Robert Safian, MD

Oakland University

Detroit, MI

 

Carlos Sanchez, MD

Riverside Methodist Hospital

Columbus, OH

 

Richard Schatz, MD

Scripps Clinic

La Jolla, CA

 

Kris Shah

Baylis Medical

Montreal, Canada

 

Richard Shlofmitz, MD

St. Francis Hospital

Roslyn, NY

 

Horst Sievert, MD

Sankt Katharinen Hospital

Frankfurt, Germany

 

Charles Simonton, MD

Abbott

San Francisco, CA

 

John Simpson, MD

Avinger

Redwood City, CA

 

Gregg Stone, MD

CRF

New York, NY

 

Jianhua Sun, PhD

Sinomed Group

Tianjin City, China

 

Gregg Sutton

Surmodics, Inc.

Minneapolis, MN

 

Renu Virmani, MD

CV Path Institute

Washington, DC

 

Dee Dee Wang, MD

Henry Ford Health System and Henry Ford Innovation Institute

Detroit, MI

 

Brian Whisenant, MD

Proximare Inc

Salt Lake City, UT

 

Changfu Wu, MD

FDA

Silver Spring, MD

 

Magdi Yacoub, MD

Imperial College

London, England

 

Steven Yakubov, MD

Ohio Health Physician Group

Columbus, OH

 

Paul Yock, MD

Stanford University

Palo Alto, CA

Agenda

Introduction

8:00 am

Welcome Statement

Anthony DeMaria

8:05 am

ISCTR Mission and Statement of Meeting Purpose

Nabil Dib

8:15 am

Presentation of the ISCTR-Nelson Award

David Holmes Jr., Diana Nelson

Keynote Address

8:20 am

Education and Implementation of the Translational Pathways Document

Spencer King III

Session I: Device Development: Essential Concepts

8:35 am

Session I: Device Development: Essential Concepts

Moderators : Anthony DeMaria, David Holmes Jr.

8:36 am

Choosing an Innovative Concept

Todd Brinton

8:43 am

Intellectual Property

James Inskeep

8:50 am

Business Plan, Development, and Fundraising

Stanton Rowe

8:57 am

Conflict of Interest and Product Development

Anthony DeMaria

9:04 am

Adoption of Technology

Ian Meredith

9:11 am

Session I Panel Discussion

Discussants : Todd Brinton, Anthony DeMaria, Tonya Dowd, Andrew Farb, Peter Fitzgerald, James Inskeep, Ian Meredith, David Reuter, Gary Roubin, Stanton Rowe, Jianhua Sun

9:31 am

BREAK

Session II: Device Development: Focus on Diagnostic Devices

9:45 am

Session II: Device Development: Focus on Diagnostic Devices

Moderators : Mitchell Krucoff, Bram Zuckerman

9:46 am

Advanced Cardiac Anatomy - Application in Translational Research Tailored to Current and Future Technology

Renu Virmani

10:01 am

Advanced Cardiac Imaging - Application in Translational Research Tailored to Current and Future Technology

Jeroen Bax

10:16 am

Statistics for Evaluation of Cardiovascular Diagnostic Devices

Chris Mullin

10:31 am

Regulatory Review of Cardiovascular Diagnostic Devices: FDA Perspective

Marco Cannella

10:46 am

Regulatory Review of Cardiovascular Devices: European Regulatory Perspective

Robert Byrne

11:01 am

Guideline Requirement for Diagnostic Devices

Roxana Mehran

11:16 am

Reimbursement for Diagnostic Devices

Lori Ashby

11:31 am

Session II Panel Discussion

Discussants : Lori Ashby, Jeroen Bax, Robert Byrne, Marco Cannella, Seth Clancy, Anthony DeMaria, Avi Fischer, Louis Jacques, Roxana Mehran, Chris Mullin, Jaime Murillo, Robert Roberts, Renu Virmani

11:51 am

Lunch

Session III: Advances in the Assessment of High Risk Coronary Lesions

12:16 pm

Session III: Advances in the Assessment of High Risk Coronary Lesions

Moderators : Robert Bonow, Campbell Rogers

12:17 pm

Unmet Clinical Needs, Value Added and Future Direction in CT Lesion Assessment

James Min

12:24 pm

Unmet Clinical Needs, Value Added and Future Direction in Intracoronary Lesion Assessment (FFR, IVUS, OCT, Infrared)

Morton Kern

12:31 pm

Non-Clinical Evaluation

Robert Safian

12:38 pm

Regulatory Perspectives

Shawn Forrest

12:45 pm

Session III Panel Discussion

Discussants : Jeroen Bax, Daniel Berman, Carlos Collet, Shawn Forrest, Morton Kern, Adrian Magee, James Min, James E. Muller, Jaime Murillo, Manesh Patel, Paul Yock

Session IV: Translational Pathways for Structural Heart Intervention Imaging

1:00 pm

Session IV: Translational Pathways for Structural Heart Intervention Imaging

Moderators : Rebecca Hahn, Dee Dee Wang

1:01 pm

Unmet Clinical Needs and Future Directions

Steven Yakubov

1:08 pm

Non-Clinical Evaluation

Rebecca Hahn

1:15 pm

Regulatory Perspectives

Changfu Wu

1:22 pm

Session IV Panel Discussion

Discussants : Tobias Bohling, Tonya Dowd, Andrew Farb, Steven Goldberg, Rebecca Hahn, Christopher Panarites, Carlos Sanchez, Changfu Wu, Steven Yakubov

1:37 pm

Break

Session V: Translational Pathways for Left Appendage Closure Devices

1:48 pm

Session V: Translational Pathways for Left Appendage Closure Devices

Moderators : David Holmes Jr., Ian Meredith

1:49 pm

Unmet Clinical Needs and Future Directions

Brian Whisenant

1:56 pm

Current and Future LAA Imaging Modalities to Optimize LAA Closure

Dee Dee Wang

2:03 pm

Regulatory Perspectives

Rachel Neubrander

2:10 pm

Session V Panel Discussion

Discussants : Tonya Dowd, Andrew Farb, Rebecca Hahn, Louis Jacques, Chris Mullin, Rachel Neubrander, Mark Reisman, Kris Shah, Horst Sievert, Renu Virmani, Dee Dee Wang, Brian Whisenant

Session VI: Translational Pathway for Interventional Devices for Heart Failure

2:30 pm

Session VI: Translational Pathway for Interventional Devices for Heart Failure

Moderators : Nicole Ibrahim, William O'Neill

2:31 pm

Overview Interventional Devices for Heart Failure

William Abraham

2:38 pm

Current Landscape and Future Directions - Percutaneous Ventricular Assist Devices

William O'Neill

2:45 pm

Current Landscape and Future Direction of Neuromodulation Therapies

Horst Sievert

2:52 pm

Current Landscape and Future Directions - Intracardiac Shunts, Ventricular Remodeling Therapies

Gregg Stone

2:59 pm

Non-Clinical Evaluation

Navin Kapur

3:06 pm

Regulatory Perspective

Ileana Piña

3:13 pm

Session VI Panel Discussion

Discussants : William Abraham, Fernando Aguel, Seth Bilazarian, Seth Clancy, Navin Kapur, Morton Kern, Chris Mullin, Ileana Piña, Rhonda Robb, Horst Sievert, Gregg Stone, Magdi Yacoub

3:33 pm

Break

Session VII: Revascularization and Devices for Complex Coronary Lesions - Calcified, Total Occlusion

3:43 pm

Session VII: Revascularization and Devices for Complex Coronary Lesions - Calcified, Total Occlusion

Moderators : Charles Simonton, Gregg Stone

3:44 pm

Unmet Clinical Needs/Current and Future Direction

Ajay Kirtane

3:51 pm

Non-Clinical Evaluation

Kevin Croce

3:58 pm

FDA Perspectives

Lydia Glaw

4:05 pm

Session VII Panel Discussion

Discussants : Kevin Croce, Ryan Egeland, Lydia Glaw, Louis Jacques, Ajay Kirtane, Adrian Magee, Richard Shlofmitz, Renu Virmani

Session VIII: Meet the Legends of Innovation - Challenges in Cardiovascular Device Development

4:19 pm

Session VIII: Meet the Legends of Innovation - Challenges in Cardiovascular Device Development

Moderators : Martin Leon, Paul Yock

4:20 pm

Session VIII Meet the Legends Round Table Discussion

Discussants : Neal Fearnot, David Holmes Jr., Louis Jacques, Spencer King III, James E. Muller, Julio Palmaz, David Reuter, Gary Roubin, Stanton Rowe, Richard Schatz, Charles Simonton, John Simpson, Gregg Stone, Gregg Sutton, Magdi Yacoub, Bram Zuckerman

4:55 pm

Closing Remarks

Nabil Dib

5:00 pm

Adjourn