Medtronic says FDA clears CoreValve
Medtronic said Friday that the Food and Drug Administration cleared its CoreValve system, a replacement heart valve for patients who are too sick for open heart surgery.
CoreValve is intended for patients with severe aortic stenosis. In clinical trials Medtronic said patients who had the valve implanted were less likely to die or suffer a major stroke in the first year after the procedure. CoreValve is a prosthetic valve delivered through a catheter. It is snaked up to the heart through an incision in the groin. The procedure is a less-invasive alternative to open heart surgery, which many patients are too weak or sick to survive.
European Union regulators approved CoreValve in 2007.
Competitor Edwards Lifesciences has been selling a replacement heart valve called Sapien since 2011, and Sapien is delivered through a similar procedure. The two companies are in litigation. On Wednesday a federal jury ruled that Medtronic infringed on a patent held by Edwards, ordering Medtronic to pay about $390 million in damages. Edwards said it would seek a permanent injunction to stop Medtronic from selling CoreValve in the U.S.
In 2010 a jury awarded Edwards $73 million in damages in a separate lawsuit. An appeals court upheld the ruling, and Edwards said the Minneapolis company made an initial payment of $84 million in that case in 2013.
Medtronic Inc. shares rose 25 cents to $59.36 Friday afternoon, while Edwards Lifesciences Inc. shares fell $3.88, or 5.3 percent, to $68.78.