First US patients get Edwards' heart valve implant
CHICAGO (Reuters) - Edwards Lifesciences Corp (EW.N: Quote, Profile, Research) said on Friday the first U.S. patients had received its heart valve implant to address a congenital condition in which the valve between the right ventricle and the pulmonary artery is nonfunctional.
Edwards' Sapien bovine heart valve was implanted employing a minimally invasive method using a catheter, which avoids the need for open-heart surgery.
The implants were done as part of a trial, which received conditional approval from the U.S. Food and Drug Administration in late 2007, that will include 30 patients at three hospitals. Trial data will ultimately be used to support the company's application to commercialize the product in the United States.
The approach involves taking the Sapien valve, which is compressed onto a balloon to the diameter of a pencil, and threading it through the patient's circulatory system from a vessel in the leg to the patient's pulmonary valve.
Dr. Ziyad Hijazi, director of the Center for Congenital and Structural Heart Disease at Rush University Medical Center in Chicago, said three patients, ages 14, 28 and 72, had received the valve and were recovering well. He said they were expected to be discharged from the hospital today, one day after receiving the implants.
Patients with this congenital problem typically require multiple open-heart surgeries throughout their lives, either to replace their diseased valves or, as they age, to implant prosthetic replacement valves, said Hijazi, who is also a paid consultant to Edwards.
"This clinical study will enable physicians to offer a minimally invasive alternative to symptomatic patients with a failing pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities," he said in statement.
The Sapien valve is also being studied to treat patients with severe aortic heart valve stenosis who are considered to be at high risk for conventional open-heart valve replacement surgery. Stenosis is a narrowing of the aortic valve that restricts blood flow.
Shares of Edwards were up 59 cents to $48.18, a four-month high, in morning trade on the New York Stock Exchange.
(Reporting by Debra Sherman; editing by John Wallace)
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