(MCT) Abbott Laboratories on Friday received approval from the U.S. Food and Drug Administration to begin selling a first-of-its-kind clamp for leaky heart valves called MitraClip.
The device, a tiny metallic clip designed to repair the mitral valve, which regulates blood flow on the left side of the heart, is inserted through a vein in the groin area. Abbott said the device offers a less-invasive alternative to open-heart surgery for certain patients with a heart condition called mitral regurgitation.
Abbott estimates some 4 million Americans — including one in 10 over the age of 75 — have the condition, in which the heart's mitral valve leaflets do not close tightly, allowing blood to leak back into the heart's left atrium. Left untreated, the consequences can be as severe as heart failure.
The Lake County-based health care company estimates that peak-year global sales of the product could reach several hundred million dollars.
"It certainly is exciting to have the opportunity to have this first-of-class kind of therapy where there's a demonstrable need for alternatives," said John Capek, Abbott's head of medical devices. "It's an area where there are a lot of patients (for whom) surgery is not an alternative, and this is an opportunity to improve outcomes."
MitraClip has been on the market in Europe for five years, and more than 11,000 patients worldwide have had the device implanted, Abbott said. Sales in international markets grew 50 percent in the third quarter, compared to the same period a year earlier, Capek said.
Abbott also is seeking approval for the device in Asian countries like China and Japan. MitraClip also is available through a special access program in Canada.
During clinical trials, the device has been implanted in about 1,300 patients in the U.S. at hospitals including Northwestern Memorial Hospital, Rush University Medical Center and hospitals operated by NorthShore University HealthSystem.
The device was one of the key items in the pipeline for Abbott's $3.1 billion vascular business, which also includes products like stents and scaffolds used to unclog arteries in the heart and brain.
Abbott acquired MitraClip in 2009 as part of its $320 million purchase of Menlo Park, Calif.-based Evalve Inc. The deal also included additional payments of up to $410 million tied to meeting "certain regulatory milestones," the company said at the time.
Shares of Abbott closed Thursday at $37.21, down 2 cents. Abbott stock is up 16 percent since it spun off its proprietary pharmaceutical arm into AbbVie Inc. at the start of the year.
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