/  2019 Translational Pathways For Cardiovascular Devices
Translational Pathways for Cardiovascular Devices

ISCTR - TCT 2019 Summit

September 25, 2019 Moscone Center
Room 151-153, Moscone South, Upper Mezzanine
747 Howard St., San Francisco, CA 94103
8:00am – 5:00pm

Program Directors:

Nabil Dib, Bram Zuckerman, Spencer King, Martin Leon


To Present and Discuss the Translational Pathways for Cardiovascular Diagnostic and Therapeutic Devices that Incorporates Input from Academia, Industry, FDA, and Payers.


8:00 – 8:05 AM

Welcome Statement

Anthony DeMaria View Presentation

8:05 – 8:15 AM

ISCTR Mission and Statement of Meeting Purpose

–  Nabil Dib View Presentation Slide Presentation

8:15 – 8:20 AM

Presentation of the ISCTR-Nelson Award

–  Presented by David Holmes and Diana Nelson to Spencer King

View Presentation – Holmes View Presentation – Nelson Slide Presentation

Keynote Address

8:20 – 8:35 AM

Education and Implementation of the Translational Pathways Document

Spencer King View Presentation Slide Presentation

Session I – Device Development: Essential Concepts

Moderators: David Holmes and Anthony DeMaria

8:35 – 8:42 AM

Choosing an Innovative Concept

– Todd Brinton View Presentation Slide Presentation

8:42 – 8:49 AM

Intellectual Property

James Inskeep View Presentation Slide Presentation

8:49 – 8:56 AM

Business Plan, Development, and Fundraising

– Stanton Rowe View Presentation Slide Presentation

8:56 – 9:03 AM

Conflict of Interest and Product Development

– Anthony DeMaria View Presentation Slide Presentation

9:03 – 9:10 AM

Adoption of Technology

– Ian Meredith View Presentation Slide Presentation

9:10 – 9:30 AM

Panel Discussion:

– Todd Brinton, Peter Fitzgerald, James Inskeep, Stanton Rowe, Ian Meredith, David Reuter, Jianhua Sun, Andrew Farb, Tonya Dowd, Gary Roubin View Presentation

9:30 – 9:45 AM


Session II – Device Development: Focus on Diagnostic Devices

Moderators: Bram Zuckerman and Mitchell Krucoff

9:45 – 10:00 AM

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

– Renu Virmani View Presentation Slide Presentation

10:00 – 10:15 AM

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

– Jeroen Bax Slide Presentation

10:15 – 10:30 AM

Statistics for Evaluation of Cardiovascular Diagnostic Devices

– Chris Mullin View Presentation Slide Presentation

10:30 – 10:45 AM

Regulatory Review of Cardiovascular Diagnostic Devices: FDA Perspective

– Marco Cannella View Presentation Slide Presentation

10:45 – 11:00 AM

Regulatory Review of Cardiovascular Devices: European Regulatory Perspective

– Robert Byrne View Presentation Slide Presentation

11:00 – 11:15 AM

Guideline Requirement for Diagnostic Devices

– Roxana Mehran View Presentation Slide Presentation

11:15 – 11:30 AM

Reimbursement for Diagnostic Devices

– Lori Ashby View Presentation Slide Presentation

11:30 – 11:50 AM

Panel Discussion:

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

11:50 – 12:15 PM


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

Moderators: Robert Bonow and Campbell Rogers

12:15 – 12:22 PM

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

– James Min View Presentation Slide Presentation

12:22 – 12:29 PM

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

– Morton Kern View Presentation Slide Presentation

12:29 – 12:36 PM

Non-Clinical Evaluation

– Robert Safian View Presentation Slide Presentation

12:36 – 12:43 PM

Regulatory Perspectives

– Shawn Forrest View Presentation Slide Presentation

12:43 – 12:58 PM

Panel Discussion:

– James Min, Morton Kern, Jeroen Bax, Adrian Magee, Shawn Forrest, Daniel Berman, Carlos Collet, Manesh Patel, James Muller, Jaime Murillo View Presentation

Session IV – Translational Pathways for Structural Heart Intervention Imaging

Moderators: Rebecca Hahn and Dee Dee Wang

12:58 – 1:05 PM

Unmet Clinical Needs for Tricuspid Valve Interventions

– Carlos Sanchez View Presentation Slide Presentation

1:05 – 1:12 PM

Current Imaging Limitations for Advancement Tricuspid Valve

Rebecca Hahn View Presentation Slide Presentation

1:12 – 1:19 PM

Tricuspid Valve Interventions Challenges Regulatory Perspective

– Changfu Wu View Presentation Slide Presentation

1:19 – 1:34 PM

Panel Discussion:

– Steven Yakubov, Rebecca Hahn, Changfu Wu, Carlos Sanchez, Tobias Bohling, Andrew Farb, Tonya Dowd ,Christopher Panarites, Steve Goldberg View Presentation

1:34 – 1:45 PM


Session V – Translational Pathway for Left Appendage Closure Devices

Moderators: Ian Meredith and David Holmes

1:45 – 1:52 PM

Unmet Clinical Needs and Future Directions

– Brian Whisenant View Presentation Slide Presentation

1:52 – 1:59 PM

Current and Future LAA Imaging Modalities to Optimize LAA Closure

– Dee Dee Wang View Presentation Slide Presentation

1:59 – 2:06 PM

Translational Pathways Left Appendage Closure Devices FDA Perspective

– Rachel Neubrander View Presentation Slide Presentation

2:06 – 2:26 PM

Panel Discussion:

– Brian Whisentant, Louis Jacques, Dee Dee Wang,Rachel Neubrander, Rebecca Hahn, Andrew Farb, Tonya Dowd, Kris Shah, Mark Reisman, Horst Sievert, Chris Mullin, Renu Virmani View Presentation

Session VI – Translational Pathway for Interventional Devices for Heart Failure

Moderators:  William O’Neill and Nicole Ibrahim

2:26 – 2:33 PM

Overview Interventional Devices for Heart Failure

– William Abraham View Presentation Slide Presentation

2:33 – 2:40 PM

Current Landscape and Future Directions – Percutaneous Ventricular Assist Devices

– William O’Neill View Presentation Slide Presentation

2:40 – 2:47 PM

Current Landscape and Future Direction of Neuromodulation Therapies

– Horst Seivert View Presentation Slide Presentation

2:47 – 2:54 PM

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

– Gregg Stone View Presentation Slide Presentation

2:54 – 3:01 PM

Clinical Preclinical Excellence Driving Innovation in Mechanical Circulatory Support

– Navin Kapur View Presentation Slide Presentation

3:01 – 3:08 PM

Translational Pathway Interventional Devices for Heart Failure FDA CDRH Perspective

– Ileana Piña View Presentation Slide Presentation

3:08 – 3:28 PM

Panel Discussion:

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

3:28 – 3:40 PM


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

Moderators: Gregg Stone and Charles Simonton

3:40 – 3:47 PM

Calcified Lesions Chronic Total Occlusions

-Ajay Kirtane View Presentation Slide Presentation

3:47 – 3:54 PM

Revascularization Devices for Complex Coronary Lesions

Kevin Croce View Presentation Slide Presentation

3:54 – 4:01 PM

Devices for Complex Coronary Lesions FDA Perspective

Lydia Glaw View Presentation Slide Presentation

4:01 – 4:21 PM

Panel Discussion:

– Kevin Croce, Louis Jacques, Ryan Egeland, Richard Shlofmitz, Ajay Kirtane, Adrian Magee, Lydia Glaw, Renu Virmani View Presentation

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

Moderators: Martin Leon and Paul Yock

4:21 – 5:00 PM

Round Table Discussion:

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

View Presentation

Closing Remarks

Nabil Dib 

View Presentation

ISCTR-TCT 2019 Meeting Speakers

William Abraham, MD

Professor of Medicine, Physiology and Cell Biology
Ohio State University
Columbus, OH

Fernando Aguel

Branch Chief of Circulatory Support Devices Branch in Division of Cardiovascular Devices
Silver Spring, MD

Lori Ashby

Director, Division of Policy and Evidence Review
Centers for Medicare and Medicaid Services
Baltimore, MD

Jeroen Bax, MD

Immediate Past President, ESC
University of Leiden
Leiden, Netherlands

Daniel Berman, MD

Professor of Medicine and Imaging
Cedars-Sinai Medical Center
Los Angeles, CA

Seth Bilazarian, MD

Chief Medical Officer
Boston, MA

Tobias Bohling

Director, Intracardiac Echocardiography Catheters
Siemens Healthineers
Sunnyvale, CA

Robert Bonow, MD

Vice Chair for Development and Innovation
Northwestern University
Chicago, IL

Todd Brinton, MD

VP, Advanced Technology & CMO
Edwards Lifesciences
Irvine, CA

Robert A. Byrne, MD, BCh, PhD

Duetsches Herzzentrum
Klinik an der Technischen Universität

Marco Cannella, PhD

Senior Lead Reviewer Cardiac Electrophysiology Devices Branch
Silver Spring, MD

Seth Clancy

Senior Director, Global Health Economics and Reimbursement
Edward Lifesciences
Irvine, CA

Carlos Collet, MD

OLV Ziekenhuis Aalst-Asse-Ninove Health Care

Kevin Croce, MD, PhD

Assistant Professor of Medicine
Harvard Medical School
Boston, MA

Nabil Dib, MD

Director of Cardiovascular Research, Mercy Gilbert Medical Center
President, ISCTR

Anthony DeMaria, MD

Professor of Medicine
Silpuzio Cardiovascular Center
San Diego, CA

Tonya Dowd

Director, Franchise Health Economics and Market Access, Cardiovascular and Specialty Solutions, Johnson & Johnson
Orange County, CA

Ryan Egeland, MD, PhD, MBA

Chief Medical Officer
Cardiovascular Systems, Inc.
Saint Paul, MN

Andrew Farb, MD

Chief Medical Officer
Division of Cardiovascular Devices, Office of Device Evaluation
Silver Spring, MD

Neal Fearnot, PhD

Vice President
Cook Group, Inc.
Bloomington, IN

Avi Fischer, MD

Chief Medical Officer
Abbott Cardiac Rhythm
New York, NY

Peter Fitzgerald, MD, PhD

Professor of Medicine and Engineering
Director, Center for Cardiovascular Innovation
Stanford University Medical Center
Palo Alto, CA

Shawn Forrest

Acting Branch Chief
Cardiac Diagnostic Devices Branch
Silver Spring, MD

Lydia Glaw, PhD

Senior Lead Reviewer, Interventional Cardiology Devices Branch of the Division of Cardiovascular Devices
Silver Spring, MD

Steve Goldberg, MD

Chief Medical Officer
Cardiac Dimensions,
Kirkland, Washington

Rebecca Hahn, MD

Director of Interventional Echocardiography
NewYork-Presbyterian/ Columbia University Medical Center
New York, NY

David Holmes, MD

Professor of Medicine
Mayo Clinic
Minneapolis, MN

Nicole Ibrahim

Biomedical Engineer
Silver Spring, MD

James Inskeep, Esq.

Inskeep Intellectual Property Group
Torrance, CA

Louis Jacques, MD

Chief Clinical Officer & Sr. Vice President
Washington, DC

Navin Kapur, MD

Associate Professor
Tufts Medical Center
Boston, MA

Morton Kern, MD

Chief of Medicine, VA Long Beach Health Care System School of Medicine
Long Beach, CA

Spencer King, MD

Professor Emeritus
Emory University
Atlanta, GA

Ajay J. Kirtane, MD

Associate Professor of Medicine
Columbia University Medical Center
New York, NY

Mitchell W. Krucoff, MD, FACC, FAHA, FSCAI

Professor Medicine/Cardiology, Duke University Medical Center
Director, Cardiovascular Devices Unit, Duke Clinical Research Institute
Durham, NC

Martin Leon, MD

President, CRF
Columbia University
New York, NY

Adrian Magee, MD

Division of Cardiovascular Devices Office of Device Evaluation
Silver Spring, MD

Roxana Mehran, MD

Professor of Medicine in Cardiology, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
New York, NY

Ian Meredith, MD

Exec VP and Global Chief Medical Officer
Boston Scientific
Marlborough, MA

James Min, MD

Professor of Radiology and Medicine at Weill Cornell Medical College
New York Presbyterian Hospital
New York, NY

Chris Mullin

Director, Product Development Strategy
Minneapolis, MN

James Muller, MD

Founder, Chief Medical Officer, and Chairman of the Board
InfraReDx, Inc.
Burlington, MA

Jaime Murillo, MD, FACC, FASE

National Senior Medical Director
Cardiology and Vascular Services, Value Creation Team
United Healthcare
Fort Lauderdale, FL

Rachel Neubrander

Branch Chief, Structural Heart Devices Branch
Silver Spring, MD

William O’Neill, MD

Interventional Cardiologist Structural Heart Disease
Henry Ford Medical Group
Detroit, MI

Julio Palmaz, MD

Co-inventor of the Palmaz-Schatz Stent
San Francisco, CA

Christopher Panarites, PhD

Senior Director, Health Economics & Reimbursement
San Francisco, CA

Manesh Patel, MD

Chief of Cardiology, Co-Director Heart Center
Duke University
Durham, North Carolina

Ileana Piña

Professor of Epidemiology and Population Health at Albert Einstein College of Medicine
Montefiore Medical Center
Bronx, NY

Mark Reisman, MD

Director, Structural Heart Services, Heart Institute
University of Washington Medical Center
Seattle, WA

David Reuter, MD, PhD

Director, Cardiac Innovations
Seattle Children’s Hospital
Kirkland, WA

Rhonda Robb

Cardiovascular Systems, Inc.
St. Paul, MN

Robert Roberts, MD

Board of Directors
Phoenix, AZ

Campbell Rogers, MD

Executive VP and Chief Medical Officer
Heartflow, Inc.
Portola Valley, CA

Gary Roubin, MD

Director of Cardiovascular Associates
Co-Inventor of Gianturco-Roubin Flex Stent
Brookwood Baptist Health
Birmingham, AL

Campbell Rogers, MD

Chief Medical Officer
Portola Valley, CA

Stanton Rowe

Co-founder and CEO
NXT Biomedical
Irvine, CA

Robert Safian, MD

Director, Interventional Cardiology & Vascular Medicine
Oakland University
Detroit, MI

Carlos Sanchez, MD

Advanced Structural Heart Disease
Riverside Methodist Hospital
Columbus, OH

Richard Schatz, MD

Co-inventor of the Palmaz-Schatz Stent
Scripps Clinic
La Jolla, CA

Kris Shah

Baylis Medical
Montreal, QC

Richard Shlofmitz, MD

Chairman, Department of Cardiology
St. Francis Hospital
Roslyn, NY

Horst Sievert, MD

Director, CardioVascular Center Frankfurt
Sankt Katharinen Hospital

Charles Simonton, MD

Chief Medical Officer
Abbott Vascular
San Francisco, CA

John Simpson, MD

Founder and CEO
Redwood City, CA

Gregg Stone, MD

Professor of Medicine and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy
Columbia University Medical Center
New York, NY

Jianhua Sun, PhD

Chairman and CEO
Sinomed Group
Tianjin City

Gregg Sutton

VP Research & Development
Surmodics, Inc.
Minneapolis, MN

Bernard Vasseur, MD

Structural Heart Device Branch
Silver Spring, MD

Renu Virmani, MD

President and Medical Director
CV Path Institute
Washington, D.C.

Dee Dee Wang, MD

Director, Structural Heart Imaging and Medical Director, 3D Printing
Henry Ford Health System and Henry Ford Innovation Institute
Detroit, Michigan

Brian Whisenant, MD

Director of Interventional Cardiology and Owner, Proximare Inc
University of Utah
Salt Lake City, UT

Changfu Wu, PhD

Division of Cardiovascular Devices, Office of Device Evaluation
Silver Spring, MD

Uri Yaron

Biosense Webster, Johnson & Johnson
Los Angeles, CA

Magdi Yacoub, MD

Professor of Cardiothoracic Surgery
Imperial College
London, England

Steven Yakubov, MD

Ohio Health Physician Group
Columbus, OH

Paul Yock, MD

Stanford University
Palo Alto, CA

Bram Zuckerman, MD

Division of Cardiovascular Devices, Office of Device Evaluation
Silver Spring, MD

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