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."