Medtronic Wins FDA Approval for Largest TAVR System in United States

By MedTech Intelligence Staff

The device expands treatment to an additional patient population.

Today Medtronic announced FDA approval of its CoreValve Evolut, the largest transcatheter aortic valve replacement (TAVR) available in the United States. The R 34-mm valve is indicated to treat severe aortic stenosis patients who are categorized as high or extreme risk for surgery with an annulus size that ranges from 26 to 30 mm. According to Medtronic, this device can treat 25–30% of the eligible global TAVR patient population.

Now being launched in the United States, the Evolut system is delivered via the EnVeo R Delivery Catheter System, which has an InLine Sheath. The device is not available in Europe or other countries. “Heart teams can now use the Evolut R platform to treat the broadest annulus range in the U.S. market. The approval of the 34mm valve expands the patient population that can now receive this minimally invasive treatment alternative to open heart surgery,” said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic’s Cardiac and Vascular Group in a press release. “We look forward to working with physicians and heart teams across the U.S. to provide this valve to the many patients who need it.”

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