FDA has approved Medtronic's CoreValve Evolut R 34 mm transcatheter aortic valve replacement (TAVR), making it the largest valve size in the United States. The valve is not approved outside of the United States.
The approval covers use in high-risk or extreme-risk patients with severe aortic stenosis who have valve annulus sizes of 26-30 mm, according to a Medtronic press release. Those patients make up as much as 25-30% of the total patient population for TAVR therapy and the FDA nod means some of these patients, who didn't have a minimally invasive option before, do now.
|Learn about "Technology Readiness: Are You Ready to Start Formal Product Development?" at BIOMEDevice San Jose, Dec. 7-8.|
The U.S. launch may also allow Medtronic to gain some TAVR market share. Omar Ishrak, Medtronic chairman and CEO, told analysts on the company's August earnings call that "The lack of a large-size Evolut R is limiting our share in the U.S. market," according to a Seeking Alpha transcript of the earnings call.
Medtronic's management has pointed out that lacking a large size has been a drag on growth. According to a Seeking Alpha transcript of Medtronic's earnings call at the end of May, Michael Coyle, group president of the cardiac and vascular group, explained, "I think the primary difference between our growth and the market growth is the performance of the large valve segment of the Evolut R. We don't have available yet the 34 millimeter version. If we do get that product, we would expect to be able to have its share of performance and perform like the other three sizes do and provide us the share growth opportunity."
Approval seems to have come earlier than originally anticipated. In August, Ishrak pointed to expected FDA approval of the larger valve in early 2017.
"This new, larger valve offers patients with larger anatomical structures access to TAVR. For physicians, the recapturable and repositionable Evolut R can lead to increased accuracy in placement and control during the procedure," Mathew Williams, MD, co-primary investigator for the Evolut 34mm Clinical Study and chief of Adult Cardiac Surgery and director of Interventional Cardiology and the Heart Valve Program at the NYU Langone Medical Center, said in the release.
[Image courtesy of MEDTRONIC]