WASHINGTON (AP) – Medtronic Inc. said Tuesday its CoreValve artificial heart valve achieved its goal of helping more patients survive at least one year after implantation compared with the standard treatment.
Medtronic's implant is a prosthetic heart valve that is delivered through a catheter. CoreValve is snaked up to the heart through an incision in the groin, offering a less-invasive alternative to the open-heart surgical procedure that many patients are too weak or sick to survive.
The Minneapolis-based company reported that 25 percent of patients implanted with its aortic valve replacement had a fatal event or major stroke after one year. That was significantly lower than the 43 percent rate of death or stroke reported in patients treated with the standard-of-care treatment, which involves trying to widen the heart valve opening with a catheter balloon.
The study moves Medtronic, the world's largest medical device firm, one step closer to launching the CoreValve system in the U.S., though analysts don't expect the Food and Drug Administration to approve the device until April 2014 or beyond. The device is already approved in Europe and other parts of the world.
Competitor Edwards Lifesciences Corp. became the first company to win U.S. approval for a minimally-invasive heart valve in November 2011, when the FDA approved the company's Sapien valve for patients who can't have open heart surgery. Last October, the agency expanded that approval to cover patients for whom surgery was considered high-risk.
Multiple federal courts have ruled that Medtronic's CoreValve System infringes on a patent belonging to Edwards. Last year the Court of Appeals for the Federal Circuit upheld an earlier ruling that Medtronic was willfully infringing on Edward's device patent and ordered Medtronic to pay $73 million in damages.
Leerink Swann analyst Danielle Antalffy noted that Edwards is expected to launch its next-generation Sapien XT valve in the second half of 2014, just after Medtronic's valve is expected to get approval.
"Medtronic will have little to no time to gain meaningful traction ahead of the market entry of a potentially even easier to use device," Antalffy said in a note.
Some 300,000 Americans with seriously diseased aortic valves could benefit from the less-invasive procedure. The decay of the aortic valve – a flap that controls blood flow to the heart – forces the heart to work ever harder to pump blood throughout the body. More than 50,000 people a year undergo open-heart surgery to replace the valve, and thousands more are turned away, deemed too old or ill to survive the arduous operation.
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