Medtronic receives CE Mark approval for CoreValve Evolut R System

Medtronic has been granted European CE Mark approval for its new CoreValve Evolut R System.

The self-expanding, recapturable and repositionable device is the first transcatheter aortic valve implantation therapy system approved in Europe to treat aortic stenosis patients who are at intermediate risk for open-heart surgery as determined by a heart team.

Data from the NOTION clinical trial showed that comparable clinical outcomes to surgery can be achieved by using CoreValve in patients who are good surgical candidates, with lower rates of all-cause mortality and major stroke compared to surgery.

The Evolut R valve is designed to be delivered through the EnVeo R Delivery Catheter System, which features an InLine Sheath to significantly reduce its profile.

This makes it possible to treat patients with smaller vessels through the preferred transfemoral access route, while minimising the risk of major vascular complications in some subjects.

Rhonda Robb, vice-president and general manager of the heart valve therapies business at Medtronic, said: "We are continuing to support global heart teams with training and education on the Evolut R System to expand patient access to this minimally invasive treatment option."

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