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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