Medtronic (NYSE:MDT) said EuroZone regulators OK’d a pair of its CoreValve heart valves for use in valve-in-valve replacement procedures, touting the CE Mark approval as the 1st ever worldwide.
The Fridley, Minn.-based medical device company said the European Union granted approval for its CoreValve and CoreValve Evolut implants to be inserted inside of "degenerated" bioprosthetic valves that were surgically implanted to replace patients’ ailing aortic valves.
It’s a potentially significant niche in a market estimated to hit $2 billion over the next 5 years, as the bioprosthetic valves wear out at increasing rates. The older tissue-based valves last about 15 years, Medtronic said. Each year there are roughly 200,000 surgical valve implantations globally, the company said.
Unlike their older cousins, transcatheter aortic valve implants like the CoreValve device and Edwards Lifesciences‘s (NYSE:EW) Sapien implant are inserted via catheter through the femoral artery.
Medtronic said the valve-in-valve procedure OK’d in Europe is for patients "at extreme or high risk for surgery" who would go untreated otherwise. The EU nod includes all 4 sizes of the CoreValve device and 3 delivery avenues: via the transfemoral route, the subclavian artery or through direct aortic access, according to a press release.
"We are pleased to now extend this safe and less-invasive, valve-in-valve procedure. This approach allows patients to avoid a second open-heart surgery to replace a failing surgical valve, which was originally performed to replace their own diseased valve," Dr. John Liddicoat, president of Medtronic’s structural heart business, said in prepared remarks. "Furthermore, the impressive improvements in hemodynamic performance, due to CoreValve’s supra-annular design, are showcased in the results of these valve-in-valve procedures."
Medtronic is racing to catch Edwards and its Sapien valve, which was 1st to market in the U.S. A pivotal U.S. trial for CoreValve includes an arm to study valve-in-valve replacements in extreme-risk patients, according to the release. The device has been on the European market since 2007.
