Contact: Stephanie Abraham, sabraham@acc.org, 202-375-6296

American College of Cardiology President John G. Harold, MD, MACC, made the following statement today regarding expanded indication for Edwards’ Sapien Transcatheter Heart Valves:
 

“The U.S. Food and Drug Administration’s decision to make an artificial heart valve available to an expanded group of patients who have inoperable aortic valve stenosis highlights the value of The Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. The STS/ACC TVT Registry is part of the ACC’s suite of National Cardiovascular Data Registries and the Society of Thoracic Surgeons Database. The FDA's decision is a true testament to the efficiency of rigorous clinical registries, which allowed FDA to make a prompt decision that will impact thousands of patients who previously would have not had access to this procedure.”

 

The mission of the American College of Cardiology is to transform cardiovascular care and improve heart health. The College is a 43,000-member medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College is a leader in the formulation of health policy, standards and guidelines. The ACC provides professional education, operates national registries to measure and improve quality of care, disseminates cardiovascular research, and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit cardiosource.org/ACC.

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