FDA grants TAVR IDE to medical societies

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 - Sapien valve
Edwards Sapien valve
Source: Edwards Lifesciences

The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have received an investigational device exemption (IDE) from the FDA to study alternative access approaches for transcatheter aortic valve replacement (TAVR) using the STS/ACC TVT Registry.

The IDE is believed to be a first for any medical specialty society. The ACC and STS also are trying to obtain FDA approval for additional IDE studies, according to a report by The Gray Sheet. 

The FDA approved use of the transfemoral approach to TAVR using the Sapien valve (Edwards Lifesciences) in inoperable patients with aortic stenosis on Nov. 2, 2011. About one year later, the FDA also approved the valve in high-risk aortic stenosis patients using both the transfemoral and transapical approaches.

One in four patients is ineligible for these procedures because of inadequate vessel size, vessel disease or other considerations, the societies estimated. The new STS/ACC study protocol, as approved by the Centers for Medicare & Medicaid Services (CMS), allows Medicare reimbursement for alternative access to the aortic valve via the heart muscle or the aorta (transaortic approach) in inoperable patients involved in the study.

“The goal of this study is controlled off-label use of an approved device,” Michael Mack, MD, past president of STS and chair of the STS/ACC TVT Registry Steering Committee, said in a release. “Specifically, we hope to gain complete and accurate information regarding off-label use that may ultimately lead to label expansion.”

The trial will be conducted in the TVT Registry, and the 180 sites currently using the TVT Registry will have the opportunity to participate.

The Gray Sheet report listed two additional IDE studies being sought by the societies: one to study transaortic and other approaches in high-risk but operable patients, and another to study valve-in-valve TAVR procedures. The two studies would use the TVT Registry. Mack estimated in the report that approval would be given in the coming months.

Last year, the STS and the ACC worked with the FDA and CMS to streamline the approach required for device approval and subsequent Medicare coverage for TAVR through a National Coverage Determination (NCD). 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 one year and complies with relevant patient privacy protections.