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Edwards Lifesciences down on address of FDA delay

Shares of medical accessory maker Edwards Lifesciences Inc. fell Monday on letters that the company's awful advancing aortic affection valve could be delayed by added than six months.

The Sapien valve is beneath analysis by the Food and Drug Administration, which was accepted to accomplish a cardinal afore year's end. But Wells Fargo analyst Larry Biegelsen appear that cardiologist Dr. Jeffrey Borer about declared at a Chicago medical affair that Sapien would not be accustomed until April 2012.

Borer was one of nine experts who absolutely recommended the FDA accept Sapien at a accessible affair in July. The FDA about consults a accumulation of alfresco medical experts if reviewing avant-garde medical implants. It generally follows their recommendations but sometimes doesn't.

Shares of Irvine, Calif.-based Edwards Lifesciences Corp. fell $1.91, or 2.7 percent, to $70.09 in morning trading.

Despite Borer's affiliation to the FDA panel, Biegelsen states in a analysis note: "We accept Dr. Borer was just apperception and we abide assured that Sapien will be accustomed shortly."

An Edwards agent didn't anon acknowledge to requests for comment.

Biegelsen expects the affection sanitary valves to accomplish $210 actor in sales in 2012. A six-month adjournment would abate sales to about $110 million.

If approved, the implant would be the aboriginal bogus aortic butterfly valve that can be threaded into abode through one of the body's above arteries. Cardiologists achievement this access could action a new advantage for patients who aren't advantageous abundant to abide the added invasive open-heart surgery, which has been acclimated for decades to alter valves.

The aortic reversing valve is the heart's capital doorway. About 300,000 U.S. patients ache from abasement of the valve, which armament the affection to plan harder to pump blood. Eventually the action can advance to affection failure, claret clots and abrupt death.

Some analysts accept projected Sapien could eventually accomplish sales of over $1 billion annually.