|Medtronic's CoreValve--Courtesy of Medtronic|
Medtronic ($MDT) scored a pivotal CE mark that will help expand the market for its CoreValve transcatheter aortic valve replacement (TAVR). This latest regulatory nod grants surgeons the ability to use the tech for transcathether valve-in-valve procedures where the new part is placed inside an old, expired replacement valve.
The company bills its latest CE marking as the first regulatory approval of its kind for valve-in-valve procedures--which aren't yet approved in the U.S.
Why would valve-in-valve procedures for valve replacement matter? As Medtronic explains, the option is designed to replace an aortic valve replacement, which usually has a 15-year lifespan before it needs replacement due to age and degeneration. Not every patient in this situation can endure another surgery, however, and the valve-in-valve procedure is meant to be a minimally invasive alternative that can treat this class of patients. The procedure involves using a special catheter to place CoreValve inside the decaying valve.
Data from the global VIV registry helped support the company's latest CoreValve-related CE mark with a look at 202 patients across 38 different sites around the world, 124 of which received the CoreValve implant through a valve-in-valve procedure.
CoreValve isn't approved yet in the U.S., though the FDA has allowed the use of the valve-in-valve procedures as part of its U.S. CoreValve clinical trials. There's plenty at stake here--200,000 people annually receive surgical aortic valve replacements, Medtronic estimates, and they often live long enough to require another valve replacement after the old part expires.
Medtronic recently touted more positive results for CoreValve, citing low mortality rates after one year for the TAVI device--which is in fierce competition with Edwards Lifesciences' ($EW) Sapien valve. Medtronic also cited a new study showing CoreValve is cost-effective compared to standard medical care. But Medtronic continues to be locked in a fierce battle with Edwards over CoreValve. The company paid Edwards $83.6 million earlier this year to settle a 2010 jury verdict it lost in a battle over heart valve patents relating to CoreValve. And further court action is possible.
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