STS Supports FDA Approval of Transcatheter Valve Therapy in the United States
FOR IMMEDIATE RELEASE
Contact: Rachel Estrada, restrada [at] sts [dot] org, (312) 202-5865
Cardiothoracic surgeons applaud approval of new medical device for inoperable patients
CHICAGO, IL, Nov. 3, 2011 – Today, The Society of Thoracic Surgeons (STS), released a statement in support of the U.S. Food and Drug Administration’s approval of a new medical device that uses minimally invasive catheter-based technology to treat heart valve disease.
This new therapy, known as transcatheter aortic valve replacement (TAVR), will now be an option for elderly U.S. patients with aortic stenosis who were too sick, frail, or high risk for conventional surgical therapy.
The Society of Thoracic Surgeons and the American College of Cardiology (ACC) have been working closely with the FDA and the Centers for Medicare and Medicaid Services (CMS) to develop strategies for optimizing patient safety and access in the introduction of this new technology to the American patient population.
Michael J. Mack, MD, FACC, president of STS released the following statement:
“The Society of Thoracic Surgeons is pleased to have the opportunity to work with the American College of Cardiology, the FDA, CMS, and Edwards Lifesciences in a coordinated effort to optimize patient safety, including the use of specialized heart centers with multidisciplinary heart teams, operator training and credentialing standards, and the establishment of a National TVT Registry to track and monitor patient outcomes. TVT technology represents a major advance in science that will greatly benefit patients, and all parties are committed to a pathway that allows access to care for these sick, elderly patients in a safe and effective manner. STS is committed to contributing expert guidance as TVT reaches patients across America.”
STS and ACC are currently collaborating with the FDA, CMS, and Edwards Lifesciences on the development of a National TVT Registry to monitor patient outcomes for transcatheter valve replacement procedures. This registry will be launched in December 2011.
Please visit www.stsnewsroom.org for the following resources:
- STS Executive Summary FDA Comments: STS Recommendations and Guidelines for TVT Introduction
- STS Statement before the Food and Drug Administration: Circulatory System Devices Panel of the Medical Devices Advisory Committee
- Joint Statement: American College of Cardiology Foundation and The Society of Thoracic Surgeons Transcatheter Valve Therapy: A Professional Society Overview
For more information from the FDA please visit the FDA Newsroom.
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: For more information about submitted STS commentary, the STS/ACC National TVT Registry, or to arrange for an interview with Dr. Mack, contact Rachel Estrada at restrada [at] sts [dot] org or (312) 202-5865.
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