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
Objective
To Present and Discuss the Translational Pathways for Cardiovascular Diagnostic and Therapeutic Devices that Incorporates Input from Academia, Industry, FDA, and Payers.
Introduction
8:00 – 8:05 AM
Welcome Statement
– Anthony DeMaria
8:05 – 8:15 AM
ISCTR Mission and Statement of Meeting Purpose
– Nabil Dib
8:15 – 8:20 AM
Presentation of the ISCTR-Nelson Award
– Presented by David Holmes and Diana Nelson to Spencer King
Keynote Address
8:20 – 8:35 AM
Education and Implementation of the Translational Pathways Document
– Spencer King
Session I – Device Development: Essential Concepts
Moderators: David Holmes and Anthony DeMaria
8:35 – 8:42 AM
Choosing an Innovative Concept
– Todd Brinton
8:42 – 8:49 AM
Intellectual Property
– James Inskeep
8:49 – 8:56 AM
Business Plan, Development, and Fundraising
– Stanton Rowe
8:56 – 9:03 AM
Conflict of Interest and Product Development
– Anthony DeMaria
9:03 – 9:10 AM
Adoption of Technology
– Ian Meredith
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
9:30 – 9:45 AM
Break
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
10:00 – 10:15 AM
Advanced Cardiac Imaging- Application in Translational Research Tailored to Current and Future Technology
– Jeroen Bax
10:15 – 10:30 AM
Statistics for Evaluation of Cardiovascular Diagnostic Devices
– Chris Mullin
10:30 – 10:45 AM
Regulatory Review of Cardiovascular Diagnostic Devices: FDA Perspective
– Marco Cannella
10:45 – 11:00 AM
Regulatory Review of Cardiovascular Devices: European Regulatory Perspective
– Robert Byrne
11:00 – 11:15 AM
Guideline Requirement for Diagnostic Devices
– Roxana Mehran
11:15 – 11:30 AM
Reimbursement for Diagnostic Devices
– Lori Ashby
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
11:50 – 12:15 PM
Lunch
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
12:22 – 12:29 PM
Unmet Clinical Needs, Value Added and Future Direction in Intracoronary Lesion Assessment (FFR, IVUS, OCT, Infrared)
– Morton Kern
12:29 – 12:36 PM
Non-Clinical Evaluation
– Robert Safian
12:36 – 12:43 PM
Regulatory Perspectives
– Shawn Forrest
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
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
1:05 – 1:12 PM
Current Imaging Limitations for Advancement Tricuspid Valve
– Rebecca Hahn
1:12 – 1:19 PM
Tricuspid Valve Interventions Challenges Regulatory Perspective
– Changfu Wu
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
1:34 – 1:45 PM
Break
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
1:52 – 1:59 PM
Current and Future LAA Imaging Modalities to Optimize LAA Closure
– Dee Dee Wang
1:59 – 2:06 PM
Translational Pathways Left Appendage Closure Devices FDA Perspective
– Rachel Neubrander
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
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
2:33 – 2:40 PM
Current Landscape and Future Directions – Percutaneous Ventricular Assist Devices
– William O’Neill
2:40 – 2:47 PM
Current Landscape and Future Direction of Neuromodulation Therapies
– Horst Seivert
2:47 – 2:54 PM
Current Landscape and Future Directions – Intracardiac Shunts,Ventricular Remodeling Therapies
– Gregg Stone
2:54 – 3:01 PM
Clinical Preclinical Excellence Driving Innovation in Mechanical Circulatory Support
– Navin Kapur
3:01 – 3:08 PM
Translational Pathway Interventional Devices for Heart Failure FDA CDRH Perspective
– Ileana Piña
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
3:28 – 3:40 PM
Break
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
3:47 – 3:54 PM
Revascularization Devices for Complex Coronary Lesions
– Kevin Croce
3:54 – 4:01 PM
Devices for Complex Coronary Lesions FDA Perspective
– Lydia Glaw
4:01 – 4:21 PM
Panel Discussion:
– Kevin Croce, Louis Jacques, Ryan Egeland, Richard Shlofmitz, Ajay Kirtane, Adrian Magee, Lydia Glaw, Renu Virmani
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
Closing Remarks
Nabil Dib
ISCTR-TCT 2019 Meeting Speakers
William Abraham, MD
Professor of Medicine, Physiology and Cell Biology
Ohio State University
Columbus, OH
USA
Fernando Aguel
Branch Chief of Circulatory Support Devices Branch in Division of Cardiovascular Devices
FDA
Silver Spring, MD
USA
Lori Ashby
Director, Division of Policy and Evidence Review
Centers for Medicare and Medicaid Services
Baltimore, MD
USA
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
USA
Seth Bilazarian, MD
Chief Medical Officer
Abiomed
Boston, MA
USA
Tobias Bohling
Director, Intracardiac Echocardiography Catheters
Siemens Healthineers
Sunnyvale, CA
USA
Robert Bonow, MD
Vice Chair for Development and Innovation
Northwestern University
Chicago, IL
USA
Todd Brinton, MD
VP, Advanced Technology & CMO
Edwards Lifesciences
Irvine, CA
USA
Robert A. Byrne, MD, BCh, PhD
Duetsches Herzzentrum
Klinik an der Technischen Universität
Germany
Marco Cannella, PhD
Senior Lead Reviewer Cardiac Electrophysiology Devices Branch
FDA
Silver Spring, MD
USA
Seth Clancy
Senior Director, Global Health Economics and Reimbursement
Edward Lifesciences
Irvine, CA
USA
Carlos Collet, MD
OLV Ziekenhuis Aalst-Asse-Ninove Health Care
Brussels
Belgium
Kevin Croce, MD, PhD
Assistant Professor of Medicine
Harvard Medical School
Boston, MA
USA
Nabil Dib, MD
Director of Cardiovascular Research, Mercy Gilbert Medical Center
President, ISCTR
USA
Anthony DeMaria, MD
Professor of Medicine
Silpuzio Cardiovascular Center
San Diego, CA
USA
Tonya Dowd
Director, Franchise Health Economics and Market Access, Cardiovascular and Specialty Solutions, Johnson & Johnson
Orange County, CA
USA
Ryan Egeland, MD, PhD, MBA
Chief Medical Officer
Cardiovascular Systems, Inc.
Saint Paul, MN
USA
Andrew Farb, MD
Chief Medical Officer
Division of Cardiovascular Devices, Office of Device Evaluation
FDA
Silver Spring, MD
USA
Neal Fearnot, PhD
Vice President
Cook Group, Inc.
Bloomington, IN
USA
Avi Fischer, MD
Chief Medical Officer
Abbott Cardiac Rhythm
New York, NY
USA
Peter Fitzgerald, MD, PhD
Professor of Medicine and Engineering
Director, Center for Cardiovascular Innovation
Stanford University Medical Center
Palo Alto, CA
USA
Shawn Forrest
Acting Branch Chief
Cardiac Diagnostic Devices Branch
FDA
Silver Spring, MD
USA
Lydia Glaw, PhD
Senior Lead Reviewer, Interventional Cardiology Devices Branch of the Division of Cardiovascular Devices
FDA
Silver Spring, MD
USA
Steve Goldberg, MD
Chief Medical Officer
Cardiac Dimensions,
Kirkland, Washington
USA
Rebecca Hahn, MD
Director of Interventional Echocardiography
NewYork-Presbyterian/ Columbia University Medical Center
New York, NY
USA
David Holmes, MD
Professor of Medicine
Mayo Clinic
Minneapolis, MN
USA
Nicole Ibrahim
Biomedical Engineer
FDA
Silver Spring, MD
USA
James Inskeep, Esq.
Founder
Inskeep Intellectual Property Group
Torrance, CA
USA
Louis Jacques, MD
Chief Clinical Officer & Sr. Vice President
ADVI
Washington, DC
USA
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
USA
Spencer King, MD
Professor Emeritus
Emory University
Atlanta, GA
USA
Ajay J. Kirtane, MD
Associate Professor of Medicine
Columbia University Medical Center
New York, NY
USA
Mitchell W. Krucoff, MD, FACC, FAHA, FSCAI
Professor Medicine/Cardiology, Duke University Medical Center
Director, Cardiovascular Devices Unit, Duke Clinical Research Institute
Durham, NC
USA
Martin Leon, MD
President, CRF
Columbia University
New York, NY
Adrian Magee, MD
Division of Cardiovascular Devices Office of Device Evaluation
FDA
Silver Spring, MD
USA
Roxana Mehran, MD
Professor of Medicine in Cardiology, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
New York, NY
USA
Ian Meredith, MD
Exec VP and Global Chief Medical Officer
Boston Scientific
Marlborough, MA
USA
James Min, MD
Professor of Radiology and Medicine at Weill Cornell Medical College
New York Presbyterian Hospital
New York, NY
USA
Chris Mullin
Director, Product Development Strategy
NAMSA
Minneapolis, MN
USA
James Muller, MD
Founder, Chief Medical Officer, and Chairman of the Board
InfraReDx, Inc.
Burlington, MA
USA
Jaime Murillo, MD, FACC, FASE
National Senior Medical Director
Cardiology and Vascular Services, Value Creation Team
United Healthcare
Fort Lauderdale, FL
USA
Rachel Neubrander
Branch Chief, Structural Heart Devices Branch
FDA
Silver Spring, MD
USA
William O’Neill, MD
Interventional Cardiologist Structural Heart Disease
Henry Ford Medical Group
Detroit, MI
USA
Julio Palmaz, MD
Co-inventor of the Palmaz-Schatz Stent
San Francisco, CA
USA
Christopher Panarites, PhD
Senior Director, Health Economics & Reimbursement
Abbott
San Francisco, CA
USA
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
USA
Mark Reisman, MD
Director, Structural Heart Services, Heart Institute
University of Washington Medical Center
Seattle, WA
USA
David Reuter, MD, PhD
Director, Cardiac Innovations
Seattle Children’s Hospital
Kirkland, WA
USA
Rhonda Robb
COO
Cardiovascular Systems, Inc.
St. Paul, MN
USA
Robert Roberts, MD
Board of Directors
ISCTR
Phoenix, AZ
USA
Campbell Rogers, MD
Executive VP and Chief Medical Officer
Heartflow, Inc.
Portola Valley, CA
USA
Gary Roubin, MD
Director of Cardiovascular Associates
Co-Inventor of Gianturco-Roubin Flex Stent
Brookwood Baptist Health
Birmingham, AL
USA
Campbell Rogers, MD
Chief Medical Officer
Heartflow
Portola Valley, CA
USA
Stanton Rowe
Co-founder and CEO
NXT Biomedical
Irvine, CA
USA
Robert Safian, MD
Director, Interventional Cardiology & Vascular Medicine
Oakland University
Detroit, MI
USA
Carlos Sanchez, MD
Advanced Structural Heart Disease
Riverside Methodist Hospital
Columbus, OH
USA
Richard Schatz, MD
Co-inventor of the Palmaz-Schatz Stent
Scripps Clinic
La Jolla, CA
USA
Kris Shah
President
Baylis Medical
Montreal, QC
Canada
Richard Shlofmitz, MD
Chairman, Department of Cardiology
St. Francis Hospital
Roslyn, NY
USA
Horst Sievert, MD
Director, CardioVascular Center Frankfurt
Sankt Katharinen Hospital
Frankfurt
Germany
Charles Simonton, MD
Chief Medical Officer
Abbott Vascular
San Francisco, CA
USA
John Simpson, MD
Founder and CEO
Avinger
Redwood City, CA
USA
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
USA
Jianhua Sun, PhD
Chairman and CEO
Sinomed Group
Tianjin City
China
Gregg Sutton
VP Research & Development
Surmodics, Inc.
Minneapolis, MN
USA
Bernard Vasseur, MD
Structural Heart Device Branch
FDA
Silver Spring, MD
USA
Renu Virmani, MD
President and Medical Director
CV Path Institute
Washington, D.C.
USA
Dee Dee Wang, MD
Director, Structural Heart Imaging and Medical Director, 3D Printing
Henry Ford Health System and Henry Ford Innovation Institute
Detroit, Michigan
USA
Brian Whisenant, MD
Director of Interventional Cardiology and Owner, Proximare Inc
University of Utah
Salt Lake City, UT
USA
Changfu Wu, PhD
Division of Cardiovascular Devices, Office of Device Evaluation
FDA
Silver Spring, MD
USA
Uri Yaron
President
Biosense Webster, Johnson & Johnson
Los Angeles, CA
USA
Magdi Yacoub, MD
Professor of Cardiothoracic Surgery
Imperial College
London, England
Steven Yakubov, MD
Ohio Health Physician Group
Columbus, OH
USA
Paul Yock, MD
Stanford University
Palo Alto, CA
USA
Bram Zuckerman, MD
Director
Division of Cardiovascular Devices, Office of Device Evaluation
FDA
Silver Spring, MD
USA