* Results for Sapien valve published in medical journal
* Data to be discussed at medical meeting on Thursday
* Study paves way for US approval of pioneering technology
* Edwards shares rise 13 percent on NYSE (Recasts, adds analysts comments, previous dateline NEW YORK)
By Susan Kelly
CHICAGO, Sept 23 (Reuters) - Shares of Edwards LifeSciences
Corp
The New England Journal of Medicine published results late on Wednesday for the company's Sapien aortic valve, which is implanted using a less-invasive alternative to open-heart surgery. The data are also being presented at a major medical conference on Thursday.
Patients in the study were too sick to endure an open-heart procedure, and half were expected to die within two years.
"The results ... bode well for the approval of Sapien in the U.S. and for the rapid uptake of the device," said Wells Fargo Securities analyst Larry Biegelsen in a note to clients.
The 358-patient trial, Cohort B of Edwards' Partner study, studied the valve for the treatment of severe aortic stenosis, a narrowing of the valve. It met both of the clinical trial's main goals, Edwards said.
"We are hard-pressed to find many faults with these data," William Blair analyst Ben Andrew said in a research note.
The Sapien valve has been sold in Europe since 2007. The valve is threaded through arteries to the heart with a catheter inserted either in the groin or through a small incision between the rib cage, avoiding the need for open-heart surgery in which the heart is stopped.
The Partner study will form the basis of Edwards' application to the U.S. Food and Drug Administration for approval to sell the Sapien valve in the United States.
Irvine, California-based Edwards pioneered the development of so-called transcatheter heart valves, one of the fastest-growing areas in the medical technology sector.
Its global sales of transcatheter heart valves reached $53.2 million in the second quarter, and the company forecasts sales of $190 million to $205 million for the full year. Edwards had total sales of $1.32 billion in 2009.
"We believe that the Cohort B results should support U.S. approval of Sapien for use in inoperable patients," JP Morgan analyst Michael Weinstein said in a research note.
Weinstein projects that the transcatheter valve market will grow to $1.87 billion by 2015, up from $360 million now, "making it one of the most promising opportunities in medtech over the next decade." (Reporting by Susan Kelly and Lewis Krauskopf; editing by Gunna Dickson)