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Edwards Lifesciences Stops Heart Valve Test

June 14, 2005|Lisa Girion | Times Staff Writer

Edwards Lifesciences Corp., the world's largest heart-valve maker, said Monday that the death of at least one person had led it to voluntarily halt testing of a valve that is implanted while the patient is awake.

The early-stage trial involved fewer than 10 patients in the U.S., the Irvine-based company said. Executives declined to say how many deaths were involved or to discuss the cause.

But the company believes that outcomes may improve with a new method for placing the valve recently tested by a Canadian doctor, said Barry Liden, a spokesman.

The company is seeking the approval of the U.S. Food and Drug Administration to make the new method available as an option for doctors participating in the trial before enrolling more patients, he said.

Traditionally, artificial valves are implanted through open-heart surgery. The new valve is compressed to the width of a pencil and inserted in the heart with a tube threaded through the patient's artery.

Made of stainless steel and horse heart tissue, the valve is about the size of a quarter.

"This procedure and this new device allows us to replace the valve while the patient is conscious under local anesthesia without stopping the heart," Liden said.

The trial began with a delivery route approved by the FDA that went with the flow of blood. But that meant the valve had to be delivered through a tube passing through three of the heart's four chambers.

Under the new method Edwards wants to make available, the tube would be sent through the main artery, against the flow of blood and directly to its destination, Liden said.

The company expects to resume the trial by year's end.

The announcement was made after the markets closed. Shares rose 8 cents to $45.04.

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