European regulators for the 1st time approved a medical device for transcatheter valve-in-valve treatment in patients with degenerated surgical aortic valves, granting CE Mark approval to medtech titan Medtronic (NYSE:MDT) for its CoreValve and CoreValve Evolut devices.
"While surgical valves provide effective therapy for many patients, the replacement valves eventually degenerate over time, so valve-in-valve has become a topic of great clinical interest due to the needs of these patients," cardiologist Dr. Ran Kornowski, of the Rabin Medical Center and Tel-Aviv University, said in prepared remarks on behalf of the company.
Medtronic won approval to market valve-in-valve procedures for all of its CoreValve sizes, as well as via transfemoral, subclavian and direct aortic approaches.
"This is the 1st ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated," Medtronic said in a press release. "The CoreValve VIV procedures are not approved in the United States."
The Minnesota medical device giant has released a slew of reports on its CoreValve technology in recent weeks as it toured conferences such as EuroPCR and HRS 2013.
Earlier this month Medtronic announced that researchers had concluded that the CoreValve technology is a cost-effective alternative to drug therapy in treating patients with severe aortic stenosis.
In study results presented at the meeting of the American Assn. of Thoracic surgery, researchers reported positive short-term results of valve-in-valve implantation but warned that patients must be monitored following the procedure due to some noted cases of suboptimal systolic-valve performance.
In a press release touting the new valve-in-valve approval Medtronic noted positive outcomes at 1 year of follow-up in patients who had undergone valve-in-valve procedures, citing data published in a fall issue of Circulation.
MDT shares were down 0.5% to 51.29 as of about 11:45 a.m. today.
