• February 23, 2021

    Heart Valve Collaboratory announces U.S. Food and Drug Administration participation in collaborative community

DALLAS and NEW YORK – February 2021 – The Heart Valve Collaboratory (HVC) announced today that the U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community”. A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical device challenges to achieve aligned outcomes, solve shared problems, and leverage collective opportunities, in the interest of improving patient care.

“The FDA’s Center for Devices and Radiological Health is committed to fostering innovation while encouraging development of safe and effective technologies for patients,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “We can continue to protect and promote public health when key stakeholder groups work together. Collaborative communities can contribute to improvements in areas affecting patients and healthcare in the United States.”

The HVC is a dynamic and multidisciplinary community of physicians, regulators, and industry partners which aims to address knowledge gaps and advance regulatory science, clinical research, and device development to help patients with valvular heart disease. It was established in April 2020 by Baylor Scott & White Research Institute (BSWRI) and the Cardiovascular Research Foundation (CRF) to bring together leaders in the field with the goal of developing collaborative networks and working groups to advance science and patient-centered clinical therapies. Among the current projects are several consensus documents, frequent webinar Think Tanks, and brainstorming on innovation in clinical research programs. The first few Think Tanks in 2020 covered the challenges of conducting clinical research during the current pandemic and a “deep dive” into the evidence gaps in understanding and treating bicuspid aortic valve disease.

“The HVC acts as a catalyst to foster new collaborations and create opportunities for the rapid advancement of ideas,” said Martin B. Leon, MD, Founder and Chairman Emeritus of CRF and Co-Chair of the HVC. Dr. Leon is the Mallah Family Professor of Cardiology at Columbia University Irving Medical Center and Director of the Center for Interventional Vascular Therapy (CIVT) at NewYork-Presbyterian/Columbia University Irving Medical Center.

“Our goal is to catalyze innovation in device development and revitalize clinical research to rapidly address the many knowledge and evidence gaps in valvular heart disease,” he added.  

“Collaboration is critical for improving outcomes for patients with valvular disease. Together we can accelerate advancements safely so that more patients can get access to safe and effective treatments,” said Michael J. Mack, MD, Co-Chair of the HVC, Medical Director of Cardiothoracic Surgery for Baylor Scott & White Health, President of Baylor Scott & White Research Institute, and Chairman of Baylor Scott & White The Heart Hospital – Plano Research Center.

About HVC

The Heart Valve Collaboratory (HVC) is a dynamic and multidisciplinary community of physicians, regulators, and industry partners which aims to address knowledge gaps and advance regulatory science, clinical research, and device development to help patients with valvular heart disease. It was established in April 2020 by Baylor Scott & White Research Institute (BSWRI) and the Cardiovascular Research Foundation (CRF) to bring together leaders in the field with the goal of developing collaborative networks and working groups to advance science and patient-centered clinical therapies. For more information, visit www.heartvalvecollaboratory.org.

 About Baylor Scott & White Research Institute

Extending investigational expertise across more than 50 specialties areas, Baylor Scott & White Research Institute provides the business and regulatory infrastructure to accelerate medical breakthroughs and innovative new treatment models through clinical and translational activities. Baylor Scott & White Research Institute is present at sites and centers across Baylor Scott & White Health and maintains nearly 2,000 active trials each year.

About CRF

The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years, CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team. For more information, visit www.crf.org.