Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery.
The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure.
“Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evolut platform to more patients with aortic stenosis who can benefit from this therapy,” Medtronic heart valve therapies biz GM Rhonda Robb said in a press release.
Medtronic recently released data from the Surtavi trial, which evaluated intermediate-risk patients and compared against 863 patients treated with its CoreValve and Evolut R systems to 794 surgical patients. The trial met its primary endpoint of non-inferiority, and showed that patients in the trial treated with the TAVR devices showed significantly better mean aortic valve gradients at 2 years.
Results also indicated that SAVR treatments were associated with less aortic regurgitation, major vascular complications and the need for permanent pacemaker implantation, the company said.
“As evidenced by the landmark Surtavi trial, the CoreValve Evolut platform is well-suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays. It’s important to consider that in the first 30 days, patients treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study,” Dr. Michael Reardon of the Houston Methodist DeBakey Heart & Vascular Center said in a prepared statement.
In March, Medtronic said it won FDA approval for its CoreValve Evolut Pro transcatheter aortic heart valve replacement designed for treating severe aortic stenosis.
The next-gen 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, Medtronic said.