Abbott MitraClip Wins U.S. Approval for Leaky Heart Valve

Abbott Laboratories won U.S. regulatory approval for its MitraClip, a clamp for leaky heart valves that offers a less-invasive option to open-chest surgery.

The Food and Drug Administration clearance covers patients with significant degenerative disease, a subset of the 4 million Americans who suffer from mitral valve regurgitation, according to a company statement. The condition stems from a leaky valve that allows blood to flow backward in the heart, a progressive disease that damages the cardiac muscle and can cause stroke and heart failure.

The approval followed a mixed review from an FDA advisory panel in March. Neither analysts nor the Abbott Park, Illinois-based company factored MitraClip sales into their earnings estimates, said Larry Biegelsen, an analyst at Well Fargo in New York, in a Sept. 16 note to clients. He estimates the device will generate U.S. sales of less than $200 million a year for the limited patient population approved to get it.

“We estimate on the high side that there are 300,000 to 350,000 patients in the prohibitive risk for surgery category here in the United States,” said John Capek, Abbott’s head of medical devices. “Our target is probably 1/10th of that, or 20,000 to 30,000 patients. It will take awhile for the product to penetrate the market, but it’s not a small number.”

Abbott shares rose less than 1 percent to $37.25 at the close New York. The stock has gained 19 percent this year.

Abbott has two additional studies under way, the Coapt trial in the U.S. and the Reshape-HF study in Europe, that may be used to broaden the approval if the results are positive, Capek said in a telephone interview. The company worked with FDA staff members to determine which patients were most probable to benefit from the device based on the information available.

‘Prohibitive Risk’

Studies showed surgery is better at reducing symptoms from leaky valves while patients getting the MitraClip were three times less likely to die or suffer other complications. The device is inserted into the heart through a catheter. It clamps the two flapping leaflets of the valve closed in the middle like a clothespin, preventing a backwash of blood. The approach allows blood to flow out around either side of the device.

The approval covers patients with a “prohibitive risk” from conventional open heart surgery to repair the valve, as documented by a team of heart doctors. There are few alternative treatments now available for those patients and more than one-quarter of them die from the disease within a year, Capek said.

Demand for the device has increased by about 50 percent in the past year in Europe, where it now generates about $30 million a quarter, Capek said. More studies that examine the device’s ability to reduce hospitalization rates and improve patient’s function may bolster its use further, he said.

“Often times these first-of-a-kind products do take longer than average,” Capek said.