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Home Industry News Medtronic launches real-world study of CoreValve Evolut Pro valve

Medtronic launches real-world study of CoreValve Evolut Pro valve

29th September 2017

Medtronic has announced the launch of a post-market clinical study evaluating its CoreValve Evolut Pro valve system in everyday clinical practice.

The FORWARD PRO clinical study will evaluate the longer-term performance of the next-generation self-expanding transcatheter aortic valve implantation (TAVI) system over a five-year period.

A total of 600 patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery will be enrolled across 35 European sites, with safety to be assessed in terms of all-cause mortality and stroke rates at 30 days, while clinical performance will be evaluated in terms of valve haemodynamics and paravalvular regurgitation.

Dr Pieter Kappetein, vice-president for medical affairs at Medtronic's structural heart business, said: "We believe the improvements made to the self-expanding Evolut TAVI platform will continue to improve patient outcomes, and we anticipate this real-world study will demonstrate further evidence of longer-term performance and safety."

Evolut Pro valve offers an outer tissue wrap to further improve its valve sealing performance, addressing the occurrence of blood leaking through the sides of the valve.

The first ever data for the valve system showed that it was able to eliminate the risk of moderate or severe paravalvular leaks, while offering high rates of survival and a low rate of disabling stroke at 30 days.

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