Heart & Valve Collaboratory

About

Our History

Advancing the global understanding of heart and valvular disease through multi‑stakeholder collaboration.

Mission

The Heart & Valve Collaboratory (H&VC) convenes and synergizes the multidisciplinary cardiovascular ecosystem to address challenges and to transform innovation into impactful, equitable patient-centered health care solutions.

As heart and valve disease becomes more prevalent, gaps in detection, treatment, innovation, and equitable access to care remain, while regulatory and clinical research challenges can slow evidence and novel therapy development. Multi‑stakeholder collaboration through H&VC addresses these challenges to accelerate progress.

Partnership

About the FDA Collaborative Communities

Founded in 2020, the Heart & Valve Collaboratory is a patient-centered, cross-disciplinary community of physician-scientists, clinical leaders, industry partners, and MedTech innovators.

A defining element of H&VC is its ongoing collaboration with the U.S. Food and Drug Administration (FDA). Through H&VC’s collaborative community model, FDA representatives participate alongside other stakeholders, bringing an important regulatory perspective to discussions about challenges and opportunities in heart valve disease.

H&VC advances its mission through research studies, consensus development, global workshops, and educational programs. This work is guided by its expert Scientific Council and multidisciplinary working groups.

Co-founders

The people who started it

H&VC was founded as a public-private partnership between the US Food and Drug Administration, the Baylor Scott and White Research Institute, and the Cardiovascular Research Foundation.

Headshot of Martin B. Leon, MD
Martin B. Leon, MD

Columbia University Medical Center, New York, NY

Martin B. Leon, MD, is the Mallah Family Professor of Cardiology at Columbia University Irving Medical Center and Director of the Columbia Center for Interventional Care at New York-Presbyterian/ Columbia, where he also serves as Chief Innovation Officer and Director of Data Science for the Division of Cardiology. In addition to H&VC, he founded the Transcatheter Cardiovascular Therapeutics (TCT) symposium and is Chairman Emeritus of the Cardiovascular Research Foundation.
Headshot of Michael J. Mack, MD
Michael J. Mack, MD

Baylor Scott & White Health System, Dallas, TX

Mike Mack, MD, is Chairman of the Board, Baylor Scott & White Research Institute and Associate Academic Officer, Baylor Scott & White Health. In addition to founding H&VC, he is former Chair of the American Board of Thoracic Surgery and Senior Vice Chair of the NIH Cardiothoracic Surgery Trial Network (CTSN).
Headshot of Changfu Wu
Changfu Wu, PhD

FDA, Ex Officio

Changfu Wu, PhD, is a Senior Biomedical Research and Biomedical Product Assessment Service Expert at the FDA’s Center for Devices and Radiological Health, specializing in scientific and regulatory reviews of structural heart and circulatory support devices.
Headshot of Bram D. Zuckerman, MD
Bram D. Zuckerman, MD

FDA, Ex Officio

Bram Zuckerman, MD, is the Director of the FDA Office of Cardiovascular Devices. He joined the FDA Division of Cardiovascular Devices (DCD) as a Medical Officer in 1992 and has since been involved in development and review of clinical trials and safety evidence review for cardiovascular devices in the United States.

FAQ

Find out more about H&VC

The Heart & Valve Collaboratory (H&VC) is a patient-centered, cross-disciplinary community focused on heart valve and related heart disease. Founded in 2020, H&VC brings together experts from across the cardiovascular field to collaborate on research, consensus development, education, and other shared priorities.

H&VC advances its mission through research studies, consensus development, global workshops, educational programs, and multidisciplinary working groups. Its work also includes trainings, publications, tools, podcasts, and other resources focused on challenges and opportunities in heart valve and related cardiovascular disease.

H&VC brings together physician-scientists, clinical leaders, industry partners, MedTech innovators, and representatives from the U.S. Food and Drug Administration. Its work is guided by an expert Scientific Council and multidisciplinary working groups.

Collaboration with the U.S. Food and Drug Administration (FDA) is a defining element of H&VC’s collaborative community model. FDA representatives participate alongside other stakeholders, contributing a regulatory perspective to discussions about challenges and opportunities in heart valve disease.

H&VC’s work centers on heart valve and related cardiovascular disease. Current areas of work represented across its programs and resources include rheumatic heart disease, congenital and pediatric heart disease, tricuspid valve disease, clinical trial modernization, and early feasibility studies.

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