Edwards Valve Works for Inoperable Patients, FDA Says
(Corrects survival percentage in eighth paragraph.)
Edwards Lifesciences Corp. (EW)’s less- invasive heart valve works for patients with severe aortic valve narrowing who are too sick for chest-opening surgery, U.S. regulators said, while raising concerns of stroke risk.
The Food and Drug Administration staff said that twice the percentage of patients who received the so-called transcatheter valve suffered a stroke compared with those treated with other therapies in a report released today. A panel of outside advisers is set to meet July 20 to discuss the Irvine, California-company’s application for its valve called Sapien.
The Sapien device can be implanted by a catheter threaded through the leg or ribs rather than conventional chest-cracking surgery. The valve has been available in Europe since 2007. Transcatheter sales for Edwards totaled $206 million last year, according to data compiled by Bloomberg.
“There was a significant increase in the neurological event risk in the Sapien arm compared to control,” FDA said in the document.
Edwards shares fell 27 cents, or less than 1 percent, to $88.67, at 9:53 a.m. in New York Stock Exchange composite trading.
The FDA will ask the advisers to weigh the risk-benefit ratio of the valve when they meet this week.
In the clinical trial of the Sapien, about 8 percent, or 14 inoperable patients, who received the valve experienced stroke after one year compared with almost 4 percent of the patients who were treated with other therapy, such as balloon aortic valvuloplasty, according to an October report in the New England Journal of Medicine.
Valve Narrowing
Sixty-nine percent of patients who received the valve lived after one year compared with 49 percent in the standard-therapy group.
The global transcatheter valve market may reach $6 billion by 2020, Spencer Nam, managing director at Madison Williams and Co., wrote in a note to clients June 21. Minneapolis-based Medtronic Inc. (MDT) began a clinical trial in the U.S. of a rival valve in December.
About 300,000 people in the U.S. suffer from severe aortic stenosis, which is a narrowing of the valve, according to Edwards. Two-thirds undergo standard chest-cracking surgery to replace the valve, while the rest may be too high risk for surgery.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.
To contact the editor responsible for this story: Reg Gale in New York at rgale5@bloomberg.net
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