Medtronic announced Thursday that the company has received a CE Mark for valve-in-valve procedures using its CoreValve and CoreValve Evolut transcatheter aortic valve implantation system.

It is the first regulatory approval of TAVI for valve-in-valve procedures done to replace surgical aortic valves originally placed when a patient's own valves becomes diseased. The measure provides a minimally invasive option for replacing these surgical valves that have degenerated over time for patients who are at extreme or high risk for invasive, open-heart surgery.

"While surgical valves provide effective therapy for many patients, the replacement valves eventually degenerate over time, so valve-in-valve has become a topic of great clinical interest due to the needs of these patients," said Dr. Ran Kornowski, M.D., chair of cardiology at Rabin Medical Center and Tel-Aviv University in Tel-Aviv, Israel, in a news release. "European approval of the CoreValve procedure is a very important advance in the treatment of severe aortic stenosis and enables an entirely new group of patients to benefit from this transcatheter valve."

Each year, roughly 200,000 people globally get surgical aortic valves, which typically last around 15 years, according to a study published in the Journal of Thoracic and Cardiovascular Surgery.

While Medtronic's CoreValve TAVI system is approved in Europe, it is still being tested in U.S., where Edwards Lifesciences has the upper hand with the approved Sapien product. However, commercializing the procedure has proved tricky.

Separately, Medtronic also announced Thursday that it has completed enrollment in its U.S. pivotal study of the Symplicity renal denervation system to control drug-resistant hypertension.

By Arundhati Parmar, Senior Editor, MD+DI

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