STS to Provide Expert Comments to the FDA on Transcatheter Valve Therapy Introduction in the U.S.

Cardiothoracic surgeons offer patient safeguards for new medical device

WASHINGTON, D.C., July 20, 2011 – Today, The Society of Thoracic Surgeons (STS), in conjunction with the American College of Cardiology (ACC), will provide expert comments before the U.S. Food and Drug Administration on Transcatheter Aortic Valve Replacement (TAVR) – an innovative procedure that uses minimally invasive catheter-based technology to treat heart valve disease.

Michael J. Mack, MD, FACC, president of STS, will present before the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee at 1 pm EST. The panel will meet to consider the safety and efficacy of this new therapy, discuss labeling issues, and then make recommendations regarding the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences.

TAVR will bring a new therapeutic option to older patients with aortic stenosis who were too high risk for conventional surgical therapy. TAVR represents an exciting innovation in the medical device field that could potentially transform the quality of life for patients currently suffering from aortic valvular heart disease.

“Our goal at STS is to ensure the best possible patient-centered care. This technology represents a major advance in science that will greatly benefit certain patients, but care must be taken to assure its appropriate use,” said Dr. Mack. “Our recommendations to the FDA seek to serve as patient safeguards for the responsible implementation of TAVR technology.”

Expanding on the STS/ACC joint position statement published in the July issue of The Annals of Thoracic Surgery, Mack will present specific recommendations to the FDA on how to optimize patient safety, as well as comments on key clinical issues surrounding the potential release of TAVR technology.

The STS statement before the FDA will recommend the establishment of specialized heart centers, multidisciplinary heart teams, and operator training and credentialing standards. It also will call for the establishment of a joint STS/ACC database for purposes of post-market TAVR surveillance; STS and ACC advocate mandatory participation in such a database.

“STS is committed to contributing expert guidance that will optimize patient safety as this new technology is implemented,” said Dr. Mack. “Patients will need to be screened and followed very carefully. We hope our comments to the FDA today will help provide the framework necessary to build safe and effective TAVR programs across America.”

For more information from the FDA please visit: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm259846.htm

Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 6,200 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.

Note to Editors: Reporters and photographers are welcome to attend and cover this open public panel.  STS Comments will begin at 1pm EST at the Hilton Washington, DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD  20877. For more information about submitted STS commentary, or to arrange for an interview with Dr. Mack, contact Rachel Estrada at restrada [at] sts [dot] org or 312/202-5865.

Contact: Nancy Puckett, npuckett [at] sts [dot] org, (312) 202-5819 / Rachel Estrada, restrada [at] sts [dot] org, (312) 202-5865

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