Edwards Life Sciences LLC (EW)

[dealorfx]

Edwards Lifesciences heart valve study halted

Michelle Fay Cortez, Bloomberg News

Tuesday, November 8, 2011



Edwards Lifesciences Corp.'s Sapien aortic heart valve caused complications in a trial when inserted directly into the heart, leading researchers to halt the study, according to an analyst from Wells Fargo Securities.

Five of 34 patients getting Sapien died, suffered a stroke or developed kidney failure, compared with one stroke among 38 patients getting traditional surgery, said Larry Biegelsen, a Wells Fargo Securities analyst in New York, in a note to clients Tuesday. Biegelsen said he learned of the findings at the meeting of Transcatheter Cardiovascular Therapeutics in San Francisco, where the data will be presented Thursday.

The device was inserted with what is known as a transapical procedure, when the valve is threaded straight into the heart through a space between two ribs, Biegelsen said. The approach is generally performed on patients who have femoral arteries that are too clogged to enable the valve to safely pass through on the way to the heart.

The trial, called Staccato, was designed to include 200 relatively low-risk patients. It was halted after just 72 patients were treated, Biegelsen said.

Sarah Huoh, a spokeswoman for Edwards, declined to comment.

The risks probably occurred because the study had a poor design and the surgeons and cardiologists who were implanting the device didn't have enough experience, Biegelsen said, attributing the information to unidentified physicians who were gathering for the meeting in San Francisco.

Edwards, based in Irvine, won approval last week for the Sapien valve when inserted through the femoral artery and is waiting for Food and Drug Administration approval of the transapical approach.

"We continue to believe that the transapical approach to Edwards Sapien transcatheter aortic valve implant will be approved in the U.S. next year," Biegelsen wrote. "The transapical approach accounts for about half of Edwards' Sapien sales in Europe," where the device has been sold for several years, he wrote.