FDA Approves Investigational Device Exemption for STS/ACC Study of Alternative Access for TAVR

February 14, 2013—The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) announced that they have received a unique investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to study alternative access approaches for transcatheter aortic valve replacement (TAVR). The trial will be conducted using the STS/ACC TVT (transcatheter valve therapy) registry, and the 180 sites currently using the TVT registry will have the opportunity to participate. The IDE is believed to be a first for any medical specialty society, noted STS and ACC.

According to the announcement, the new STS/ACC study protocol, as approved by the Centers for Medicare and Medicaid Services (CMS), allows Medicare reimbursement for alternative access to the aortic valve via the heart muscle or the aorta in inoperable patients involved in the study.

Currently, only the transfemoral approach to TAVR using the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA) has been approved for inoperable patients. Both the transfemoral and transapical approaches have been approved for high-risk patients. STS/ACC noted that an estimated 1 in 4 patients is ineligible for these procedures because of inadequate vessel size, vessel disease, or other considerations.

“The goal of this study is controlled off-label use of an approved device,” commented Michael Mack, MD, in the press release. Dr. Mack is Past President of STS and Chair of the STS/ACC TVT Registry Steering Committee. He continued, “Specifically, we hope to gain complete and accurate information regarding off-label use that may ultimately lead to label expansion. The IDE approval represents the next step in the collaboration among professional societies, CMS, the FDA, and medical device manufacturers that resulted in the STS/ACC TVT Registry. The process required all parties to be flexible and innovative while navigating these uncharted waters. This is an iterative process that we hope will allow the safe and timely introduction of new medical device technology to our patients.”

ACC President William Zoghbi, MD, added, “The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators. We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way.”

As noted in the press release, STS and the ACC worked collaboratively last year with the FDA and the CMS to streamline the approach required for device approval and subsequent Medicare coverage for TAVR through a National Coverage Determination (NCD). STS Immediate Past President Jeffrey B. Rich, MD, stated that the NCD helps to ensure the best care for patients because the “preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach.”

The TAVR NCD requires that a treating heart team and hospital participate in a prospective, national, audited registry that consecutively enrolls TAVR patients, accepts all manufactured devices, follows patient outcomes for at least 1 year, and complies with relevant patient privacy protections.

“Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety,” stated ACC Immediate Past President David Holmes in the STS/ACC press release.