FDA Approves Study of Medtronic's TAVR System in Low-Risk Patients With Bicuspid Aortic Valves

September 20, 2018—Medtronic announced that the FDA has approved an investigational device exemption to initiate a single-arm study to evaluate the CoreValve Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valves who are at low risk of surgical mortality.

Separately, Medtronic received FDA approval for revised commercial labeling for the CoreValve Evolut TAVR system that removed a precaution for the treatment of patients with bicuspid severe aortic stenosis at intermediate or greater risk for surgical aortic valve replacement.

Although the revised labeling approval pertains to patients at intermediate risk or greater for surgical aortic valve replacement, Medtronic is studying bicuspid  patients within a separate single-arm study of the low-risk TAVR trial. In the United States, use of the CoreValve Evolut TAVR system for treatment of patients with bicuspid aortic valves at low risk of surgical mortality is investigational use only, advised Medtronic.

In the company's announcement, Jeffrey J. Popma, MD, commented, "Real-world data suggest that TAVR with the self-expanding Evolut can be a suitable treatment option for many patients with bicuspid aortic valve disease. In fact, data from the TVT Registry has shown near-parity in certain outcomes between bicuspid and tricuspid patients using the Evolut self-expanding platform.” Dr. Popma is Director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston, Massachusetts.