ACC, STS Release Statement on FDA Advisory Panel Regarding TAVR
June 13, 2012 – Today the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) released the following statement on the FDA’s Advisory Panel for Circulatory System Devices hearing regarding the possibility to expand use of the transcatheter heart valve:
“The American College of Cardiology is committed to delivering the highest level of care, and we appreciate the FDA’s consideration in bringing the transcatheter heart valve to high-risk surgical patients with severe aortic stenosis,” said ACC President William Zoghbi, MD, FACC. “The use of registries in post-approval surveillance is valuable for tracking long-term outcomes and quality of life issues for patients. The TVT Registry, sponsored by the ACC and The Society of Thoracic Surgeons, continues to grow and to become an important tool for capturing and reporting patient demographics, procedure details, and facility and physician information. If use of TVT is expanded, the registry will continue to provide important insight into clinical practice patterns and patient outcomes. The ACC is pleased that the government, industry and specialty societies have all worked together with the goal of advancing cardiovascular medicine.”
"It is important to strike a balance between access to care and safety and effectiveness," said STS President Jeffrey B. Rich, MD. "As physicians, we want to ensure that the right patients get the right devices at the right time. Through the support and cooperation of multiple stakeholders, from physicians to private industry, and the FDA and CMS, TAVR is now successfully reaching patients across the country. These patients, with severe aortic stenosis, are receiving this therapy in qualified institutions by a multidisciplinary heart team, consisting of both a cardiologist and a cardiothoracic surgeon. This heart team approach sets a new standard in patient centered care and as the use of TAVR expands, we believe all patients should receive the benefit of being treated by a heart team."
About the American College of Cardiology
The mission of the American College of Cardiology is to transform cardiovascular care and improve heart health. The College is a 40,000-member nonprofit medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers, and bestows credentials upon cardiovascular specialists who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care. More information about the association is available online at http://www.cardiosource.org/ACC.
About The Society of Thoracic Surgeons
Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 6,400 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The mission of the Society is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. Learn more at www.sts.org.