The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for Medtronic to initiate a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality.

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

“Real-world data suggests that TAVR with the self-expanding Evolut can be a suitable treatment option for many patients with bicuspid aortic valve disease,” said Jeffrey J. Popma, MD and director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston. “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.”

Estimated to affect one in five patients undergoing surgical aortic valve replacement (SAVR), bicuspid valve patients are born with two aortic valve leaflets instead of the more common three leaflets (tricuspid). While the revised labeling approval pertains to patients deemed at Intermediate Risk or greater for SAVR, Medtronic is studying bicuspid patients within a separate single-arm study of the Low Risk TAVR Trial.

In the United States, use for treatment with bicuspid aortic valves in patients who are at low risk of surgical mortality is investigational use only.

Pieter Kappetein, MD and vice president of medical affairs for Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic, said that as a leader in heart valve solutions, this label revision enables Medtronic to provide proactive training and education on procedural TAVR sizing and placement in this patient population

“The bicuspid study, in addition to new studies on TAVR efficiencies and leaflet mobility, will provide important insights as we look to further refine TAVR therapy,” Dr. Kappetein said.

Medtronic is an innovator of heart valve therapies, including the first transcatheter pulmonic valve, the first self-expanding and recapturable transcatheter aortic valve and the first transcatheter mitral valve replacement technology to be studied in a global pivotal trial.

Following the launch of the self-expanding CoreValve System in 2014, and the EvolutR system in 2015, the third-generation Evolut PRO TAVR system was approved in the United States and Europe for extreme-, high-, and intermediate-risk patients in 2017.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. A spokesman said the company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the World. VTN

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