Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery
The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.
“We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to address their patients’ needs,” heart valve therapies GM Rhonda Robb said in a press release.
Medtronic said that the clearance was supported by data from a clinical study of the CoreValve Evolut Pro, which met its primary endpoint at 30 days and reported a 98.3% rate of survival and a 1.7% rate of disabling stroke. A total of 72.4% of patients in the trial experienced trace amounts of paravalvular leakage or none at all, with no incidents of moderate or severe PVL reported at 30 days.
The Evolut Pro system is designed to be delivered through the EnVeo R delivery catheter system and is indicated for vessels as small as 5.5mm, Medtronic said. The CoreValve Evolut Pro is now available in Europe in 23mm, 26mm and 29mm sizes, the company said.
“The Evolut PRO valve has shown impressive clinical outcomes, with low paravalvular leak and pacemaker rates. With its ease-of-use and deliverability, the Evolut Pro valve will bring TAVI practice to a higher level, and I look forward to seeing it utilized in patients across Europe,” Dr. Nicolas Van Mieghem of Rotterdam, The Netherlands’ Erasmus Medical Center said in a prepared statement.
Medtronic won FDA approval for the Evolut Pro in March.