The Sapien aortic valve is threaded into place through the arteries via a catheter, eliminating the need for an open-heart procedure.

Edwards submitted its application to the U.S. Food and Drug Administration last fall based on data from the Cohort B portion of its Partner clinical trial for patients with severe aortic stenosis, a narrowing of the valve, who are considered too sick for open-heart surgery.

If approved, the Edwards valve would be the first so-called transcatheter aortic valve sold in the United States. Edwards has sold such a valve in Europe since 2007.

Analysts have pegged the worldwide market opportunity for transcatheter aortic valves at more than $2 billion in annual sales.

Wells Fargo Securities analyst Larry Biegelsen said the Edwards valve appears on track for a U.S. launch in the fourth quarter of this year.

"Given the high mortality benefit seen in Partner Cohort B, we expect a positive panel recommendation and ultimately FDA approval of Sapien," Biegelsen wrote in a note to clients.

He said he expects an FDA panel to review Cohort A data from the Partner trial late this year or in early 2012.

Edwards shares rose 59 cents to $86.60 in midday trade on the New York Stock Exchange.