FDA Approves Medtronic CoreValve Evolut PRO Valve for Severe Aortic Stenosis

Larry Hand

March 22, 2017

DUBLIN, IRELAND — The US Food and Drug Administration has approved Medtronic's CoreValveEvolut PRO valve for treatment of severe aortic stenosis in symptomatic patients at high or extreme risk for open cardiac surgery, according to a company announcement[1].

The Evolut PRO design has an outer wrap intended to enhance contact between the valve and the native aortic annulus, and a porcine pericardial tissue wrap is meant to address the occurrence of blood leaking through valve sides, the company says.

The approval came days after presentation of the Evolut PRO clinical-study results at the American College of Cardiology (ACC) 2017 Scientific Sessions. The study involving 60 patients (mean age 83.3, 65% female, and 70% NYHA 3 or 4) had a high rate of survival at 30 days (98.3%) and a low rate of stroke (1.7%).

Most study patients (72.4%) experienced no or only trace amounts of paravalvular leak, and 87.9% improved in NYHA classification at 30 days.

According to the company, the Evolut PRO has a self-expanding nitinol frame with a supra-annual valve position. It is delivered via the EnVeo R delivery system and indicated for vessel diameters down to 5.5 mm. The 23-mm, 26-mm, and 29-mm sizes are available for US use, but not in other countries.

Last year Medtronic issued a safety notice for the EnVeo R after reports of vascular trauma associated with the device; the events were associated with 19 deaths.

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