The Food and Drug Administration has announced approval of the Edwards Lifesciences SAPIEN Transcatheter Heart Valve. This is one of several devices in development for use in the emerging field of transcatheter aortic valve replacement (TAVR).
In announcing the decision, Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said: "The Sapien Transcatheter Heart Valve is an example of an innovative new device that will provide some people with this condition who can’t undergo open heart surgery with the option of valve replacement." He said the FDA is committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the U.S.
The FDA also noted that Edwards Lifescience will continue to evaluate the outcomes of the SAPIEN transcatheter heart valve through a national Transcatheter Valve Therapy (TVT) Registry that will track patient safety and real world outcomes related to emerging TAVR procedures.
The American College of Cardiology and the Society of Thoracic Surgeons have been working with the FDA and the Centers for Medicare and Medicaid Services in the development of this new registry, called the TVT RegistryTM, which is scheduled to launch in late 2011. It will be the first national program to evaluate safety and efficacy of a TAVR option for patients who are otherwise considered to be high-risk or non-operable for conventional valve replacement surgery.
The registry also will serve as the main repository for clinical data related to TAVR and is positioned to capture outcomes data for additional procedures that will likely emerge in the future. The goal of the registry is to link clinical and administrative claims data to assess early and longer term outcomes. The registry forms the basis of a new platform that can be used for FDA post approval studies in future generations of transcatheter valve devices.
The FDA decision follows the recommendations from the Circulatory System Devices Panel of the Medical Devices Advisory Committee this past July. The ACC, along with representatives from STS and the Society for Cardiovascular Angiography and Interventions (SCAI), provided testimony at this hearing about the benefits of using clinical data repositories like those of the NCDR® and STS to document and optimize outcomes in patients. Each group also stressed the importance of specialty societies, industry and federal regulators to align efforts to ensure the physician community is prepared to appropriately use the technology.
It also falls closely on the heels of the CMS announcement last month that it has opened a National Coverage Determination (NCD) Analysis of TAVR based on a request from the ACC and STS. The NCD request from the ACC and STS asked CMS to cover TAVR when performed with a FDA-approved device consistent with labeled indications and any other FDA requirements. In addition, it asked that CMS permit Medicare coverage only in facilities meeting requirements as recommended by professional societies, and that coverage with evidence development be allowed for patients participating in qualified prospective clinical studies.
The ACC and STS believe that an NCD is necessary to ensure nationally uniform coverage for Medicare patients who can benefit from TAVR. In addition, an NCD would ensure national standards for facilities and physicians performing TAVR and that data are collected to enable ongoing analysis of outcomes.