Medtronic announces CE Mark, EU launch of CoreValve Evolut PRO
Medtronic announced CE mark and European launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. Clinical data for the Evolut PRO valve was recently unveiled at the American College of Cardiology 66th Annual Scientific Session, and showed high survival, low rates of stroke, minimal paravalvular leak and excellent hemodynamics. The Evolut PRO device features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve.