Edwards Lifesciences gets FDA OK to expand use of Sapien valve

Edwards Lifesciences Corp., the Irvine maker of artificial aortic valves, won U.S. approval to expand use of the company's Sapien device as an alternative to open-heart surgery.

The Food and Drug Administration cleared the product for patients considered high risk but capable of handling surgery, the agency said Friday. Sapien, a so-called transcatheter heart valve that can be implanted with minimal incisions, was approved in November for patients considered too sick for open-heart surgery.

The global market for the valves may expand to $3.1 billion in 2017, with Edwards owning as much as 45% of sales, according to Barclays analysts. Transcatheter valve revenue for Edwards, which was $333 million last year, is estimated to rise to $530 million to $560 million in 2012, the company said Friday.

"Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. The Sapien valve "serves as an alternative for some very high-risk patients."

The device is meant to treat severe aortic stenosis. The debilitating condition is caused by a narrowing of the valve that restricts the ability of blood to enter the aorta, the main artery that carries blood from the heart, according to the National Institutes of Health. The label for the device advises that a heart surgeon should be involved in determining whether Sapien is appropriate for the patient.

With Sapien's FDA clearance last year, U.S. sales for Edwards grew 37%, Chief Executive Michael Mussallem said during a July 24 earnings call. Edwards' U.S. transcatheter valve sales are forecast to increase 62% to $420 million in 2013, according to Barclays.

Separately Friday, Edwards reported that net income for the third quarter rose to $69.2 million, or 58 cents a share, from $51.6 million, or 43 cents, a year earlier. The earnings topped the average of 54 cents of analysts' estimates compiled by Bloomberg.

Medtronic Inc. is testing a similar device called CoreValve that is expected to receive U.S. approval in 2014 for inoperable patients and those who are capable of handling surgery, according to Barclays.

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