Medtronic reports positive study data for CoreValve Evolut R system

Medtronic has announced new clinical data underlining the benefits offered by its self-expanding CoreValve Evolut R system.

The company's recapturable transcatheter aortic valve replacement technology offering was recently evaluated in the Evolut R US IDE study, showing the high rates of survival, low occurrence of stroke and strong haemodynamics associated with the device.

It was demonstrated that 241 extreme or high-risk patients with symptomatic severe aortic stenosis experienced a 91.4 percent survival rate and a 5.1 percent rate of disabling stroke after one year of treatment.

Additionally, initial use of the larger Evolut R 34 mm valve resulted in no deaths, no strokes, no vascular complications and two pacemaker implants at 30 days.

Rhonda Robb, vice-president and general manager of Medtronic's heart valve therapies business, said: "One-year data from the Evolut R US IDE study reinforce the positive results from the Evolut R CE Study, demonstrating the unique ability of the Evolut R system design to assist with valve placement accuracy and improve clinical outcomes."

The Evolut R 23 mm, 26 mm and 29 mm valves and the CoreValve EnVeo R Delivery Catheter System are all approved in Europe, while the 34 mm valve size is currently only available in the US.

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