FDA gives IDE approval to Society of Thoracic Surgeons and American College of Cardiology for TAVI study


The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have been given FDA investigational device exemption (IDE) approval to study alternative access routes with transcatheter aortic valve implantation (TAVI)—the IDE approval is believed to be a first for any medical specialty society.

At present, only the transfemoral approach to TAVI using the Edwards Sapien valve has been approved for inoperable patients. Both the transfemoral and transapical approaches have been approved for high-risk patients. The new STS/ACC study protocol, as approved by Centers for Medicare and Medicaid  Services (CMS), allows Medicare reimbursement for alternative access to the aortic valve via the transaortic approach) in inoperable patients involved in the study.


“The goal of this study is controlled off-label use of an approved device,” said Michael Mack, past president of STS and chair of the STS/ACC TVT Registry Steering Committee. “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.”


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


Last year, STS and the ACC worked collaboratively with the FDA and the CMS to streamline the approach required for device approval and subsequent Medicare coverage for TAVI through a National Coverage Determination (NCD), a process that STS immediate past president Jeffrey B. Rich, described as a “phenomenal” effort by everyone involved.


Rich added that the NCD helps to ensure the best care for patients because the “pre-operative evaluation, inter-operative deployment of the valve, and post-operative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilising the heart team approach.”


The TAVI NCD requires that a treating heart team and hospital participate in a prospective, national, audited registry that consecutively enrols TAVI patients, accepts all manufactured devices, follows patient outcomes for at least one 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,” said ACC immediate past president David Holmes.