U.S. FDA approves Abbott device for leaking heart valve

Reuters

By Bill Berkrot

Oct 25 (Reuters) - The U.S. Food and Drug Administration hasapproved Abbott Laboratories' MitraClip medical device,used to stop heart valve leakage in patients deemed unable toendure valve repair through open heart surgery, the company saidon Friday.

The MitraClip treats mitral regurgitation, a condition inwhich the mitral valve of the heart does not close properly,causing blood leakage that can lead to stroke, heart attack oreven death.

It has estimated the disorder affects about one in 10 peopleaged 75 and older.

Those with the condition who are too frail for open heartsurgery are typically treated with medicines and have high ratesof heart failure and rehospitalizations.

"We think longer term in the U.S., (MitraClip) could be a$500 million product," said RBC Capital Markets analyst GlennNovarro. "This approval is sooner than we thought. It's apleasant surprise."

Novarro said the timing of the FDA green light was excellentas it came just ahead of a major U.S. medical meeting forinterventional cardiologists where Abbott will be able toshowcase the device.

A panel of advisers to the FDA in March voted 5-3 to recommend approval of the implantable heart device. Some panelmembers questioned whether MitraClip would be effective.

The MitraClip was approved in Europe in 2008 under a systemin which medical devices often reach the market several yearsahead of the United States..

International sales are running at about $30 million aquarter, with sales growth at about 50 percent over 2012, Abbottsaid.

U.S. sales are likely to grow slowly at first as the companyseeks reimbursement for the device, primarily from the Medicarehealthcare program, and as more physicians are trained in itsuse. The MitraClip is implanted using a minimally invasiveprocedure in which it is threaded by catheter through a veininto place in the heart to stop the leak.

There are currently 50 centers in the United States thathave experience with the device through clinical trials. Thatnumber 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 whowould likely qualify for MitraClip implantation, Capek said.

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