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FDA approves Medtronic's new recaptureable transcatheter aortic valve replacement system

MDBR Staff Writer Published 27 October 2016

Medtronic has secured approval from the US Food and Drug Administration (FDA) for its new CoreValve Evolut R 34 mm transcatheter aortic valve replacement (TAVR) system.

The CoreValve Evolut R 34 mm valve has been approved to treat severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26-30 mm.

It will be delivered through EnVeo R delivery catheter system that features an inline sheath.

Featuring self-expanding nitinol frame, the Evolut R system will set within the native aortic valve by using its supra-annular valve position.

CoreValve Evolut R 34 mm valve is not yet approved in Europe and other countries.

Medtronic vice president and general manager of the Heart Valve Therapies business Rhonda Robb said: "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.

"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."

Earlier this month, the firm secured FDA approval for its suite of cardiac rhythm and heart failure devices and leads to scan in both 3 and 1.5 Tesla (T) magnetic resonance imaging machines.

Patients can now access Medtronic SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds).