Edwards Lifesciences Shares Soar on Heart-Valve Procedure Study Results

Edwards Lifesciences Corp. shares hit an all-time high Monday after the company issued data this weekend showing its less-invasive heart-valve procedure wasn't inferior to open-heart surgery and was superior in some cases.

Dr. Vinod Thourani, co-principal investigator of the study, said results should establish the valve as the new benchmark for the treatment of intermediate-risk patients with severe, symptomatic aortic stenosis.

Edwards Lifesciences stock shot up 17% to its highest ever at $106.10 in Monday morning trading.

J.P. Morgan analysts said the results went "as well, if not better than anyone could have expected."

"We talked about it being potentially game changing and it was truly that," J.P Morgan said in a note, adding that physician reaction is expected to be "overwhelmingly positive."

J.P Morgan expects the transcatheter aortic valve replacement market to accelerate immediately as the U.S. Food and Drug Administration "rushes to play catch up with label."

The FDA approved the so-called SAPIEN 3 valve in June 2015 for the treatment of high-risk patients with severe, symptomatic aortic stenosis. Edwards Lifesciences has been planning for approval for the treatment of intermediate-risk patients late this year.

The procedure, which involves threading a catheter through patients' arteries to implant new aortic valves, has been hailed as a technological leap in the treatment of severe aortic valve stenosis. Some doctors, however, have worried the procedure is being performed on people for whom it isn't approved.

Aortic stenosis typically occurs when calcium builds up on the valve, limiting the amount of blood pumped into the aorta, the body's largest artery, and causing fatigue and shortness of breath. The disease affects roughly 540,000 older people in North America. Doctors have decades of experience surgically implanting replacement aortic valves. The valves have proven to be durable over time, lowering the need for repeated surgeries.

The procedure, known as TAVR, is meant for patients for whom standard open-heart surgery is too risky. Compared with surgery, TAVR results in higher rates of some serious complications, including blood-vessel damage, stroke and the need for pacemakers after the procedure, studies have shown.

Results from the study released Sunday demonstrated that TAVR with the SAPIEN 3 valve was superior to surgery at one year on a composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation.

"As data continue to accumulate supporting the use of percutaneous technology in lower risk patients, the size of the opportunity continues to expand for TAVR technology," Wedbush analyst Tao Levy said. "In addition, we would expect patients who previously may have resisted the surgery due to the invasiveness of the procedure may now consider the benefits of replacing their aortic valve through a less invasive, percutaneous approach."

Wedbush estimates TAVR is on track to become a $5 billion market over the next five years, with intermediate-risk patients representing a key chunk of that growth.

Write to Anne Steele at [e-mail]

(END) Dow Jones Newswires

April 04, 2016 12:35 ET (16:35 GMT)

Copyright (c) 2016 Dow Jones & Company, Inc.