The U.S. Food and Drug Administration has approved Abbott Laboratories' MitraClip medical device, used to stop heart valve leakage in patients deemed unable to endure valve repair through open heart surgery, the company said on Friday.
The MitraClip treats mitral regurgitation, a condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack or even death.
It has estimated the disorder affects about one in 10 people aged 75 and older.
Those with the condition who are too frail for open heart surgery are typically treated with medicines and have high rates of heart failure and rehospitalizations.
"We think longer term in the U.S., (MitraClip) could be a $500 million product," said RBC Capital Markets analyst Glenn Novarro. "This approval is sooner than we thought. It's a pleasant surprise."
Novarro said the timing of the FDA green light was excellent as it came just ahead of a major U.S. medical meeting for interventional cardiologists where Abbott will be able to showcase the device.
A panel of advisers to the FDA in March voted 5-3 to recommend approval of the implantable heart device. Some panel members questioned whether MitraClip would be effective.
The MitraClip was approved in Europe in 2008 under a system in which medical devices often reach the market several years ahead of the United States.
International sales are running at about $30 million a quarter, with sales growth at about 50 percent over 2012, Abbott said.
U.S. sales are likely to grow slowly at first as the company seeks reimbursement for the device, primarily from the Medicare healthcare program, and as more physicians are trained in its use. The MitraClip is implanted using a minimally invasive procedure in which it is threaded by catheter through a vein into place in the heart to stop the leak.
There are currently 50 centers in the United States that have experience with the device through clinical trials. That number is expected to double over the next year, John Capek, Abbott's head of medical devices, said in an interview.
There are 20,000 to 30,000 patients in the United States who would likely qualify for MitraClip implantation, Capek said.