It's been a busy week for the Food and Drug Administration (FDA)! ACC President David Holmes, Jr, MD, FACC, yesterday represented the College at an FDA Medical Devices Advisory Committee panel meeting regarding pre-market approval of Edwards Lifesciences SAPIEN Transcatheter Heart Valve. Leaders from the Society for Thoracic Surgery (STS) and the Society for Cardiovascular Angiography and Interventions (SCAI) also spoke. Holmes provided well-received comments on behalf of the ACC that highlighted the issues outlined in the recent ACC/STS societal overview on transcatheter valve therapy (TVT). He also stressed the benefits of using clinical data repositories like the NCDR to document and optimize outcomes in patients, as well as identify areas that need to be changed or improved going forward. Following the hearing, the panel voted on three main questions. In general the committee agreed there was "reasonable assurance" that the SAPIEN Transcatheter Heart Valve was safe and effective for patients meeting specified criteria. They also agreed the benefits to these patients outweighed the risks. The next step is FDA approval. Your ACC has prepared a detailed summary that includes links to the official statements, more information on the specific committee questions, and background information on the PARTNER trial and ACC/STS efforts related to TVT. Future updates, including a video interview with Holmes and STS President Michael Mack, MD, FACC, will be posted here as well.
Also yesterday, the FDA announced approval of the anti-platelet drug ticagrelor for patients with acute coronary syndromes (ACS). A boxed warning to health care professionals and patients warns that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication. It also notes that, like other anti-platelet agents, ticagrelor increases the rate of bleeding and can cause significant, sometimes fatal, bleeding. Your ACC will be working with the American Heart Association to incorporate ticagrelor into future guidelines. Learn more about the decision.
Meanwhile, the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee is meeting today in response to the request for a humanitarian device exemption of Berlin Heart, Inc., for its EXCOR Pediatric Ventricular Assist Device (VAD). Your ACC submmitted written comments for the record, highlighting the importance of device manufacturers venturing into the field of pediatric devices, given the limited number of treatment options for pediatric cardiology patients in need of a bridge to transplant. The comments note that both of the current options - Extracorporeal Membrane Oxygenation (ECMO) and maximal medical therapy - have severe time limitations making them less than ideal. While the literature documents potential risks to the implantation of VADs in the pediatric population, it also indicates opportunities to extend the time limits of therapy beyond ECMO and maximal medical therapy as children wait for a new heart. The comments urge the FDA to "encourage Berlin Heart and other device manufacturers to develop additional pediatric cardiology devices that appropriately treat the needs of this special population." Read the full testimony.
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