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Edwards’s Win Yields Therapy for Frail Heart Patients

Edwards Lifesciences Corp.’s Sapien heart valve may become the first life-saving treatment in the U.S. for frail, elderly patients with diseased valves after a study found it slashed deaths in those with few medical options.

Edwards rose $7.89, or 13 percent, to $67.59 at 4 p.m. in New York Stock Exchange trading, in the biggest single-day increase since July 2002. The company’s shares have doubled in the past 12 months as investors anticipated yesterday’s study results.

Edwards, based in Irvine, California, will use this research and additional tests in healthier patients to seek FDA approval of the $30,000 valve next year. If Sapien is safer and works as well as alternatives in a broader group of patients, Edwards may double sales to $2.8 billion in five years, analysts surveyed by Bloomberg projected.

“The overall data is stronger than we expected,” Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco, said in a telephone interview. “This moves the ball down the field with respect to this technology.”

The death rate from any cause was 20 percentage points lower for patients who received Sapien, implanted without open-heart surgery, than for those who got traditional therapy designed to ease symptoms, the study published yesterday found. The results bode well for U.S. Food and Drug Administration clearance and widespread acceptance of the device, Larry Biegelsen, a Wells Fargo Securities analyst in New York, said in note to clients.

Study Results

The Sapien valve kept 69 percent of the sickest patients with damaged aortic valves alive after a year, compared with 49 percent who received standard care with blood-pressure pills and an older procedure that snakes a tiny balloon into the valve and inflates it to improve circulation. The study, published online in the New England Journal of Medicine, will be presented today at the Transcatheter Cardiovascular Therapeutics in Washington.

“You only need to treat five patients to save a life,” said Martin Leon, the lead researcher, who is a cardiologist at Columbia University Medical Center and New York-Presbyterian Hospital in New York. The device should become the new standard of care for patients who can’t withstand traditional open-heart surgery, Leon and his colleagues concluded.

The procedure wasn’t free of risks. Patients getting the valve also were significantly more likely to experience a stroke or serious vascular complication, the study found. After 30 days, 5 percent of patients who received the Edwards valve had strokes, compared with 1.1 percent on standard therapy.

‘Potential Risk’

“It is absolutely a promising therapy, but it should be deployed in patients who are reasonable candidates and who truly understand the potential risk,” said Clyde Yancy, president of the American Heart Association and medical director of the Baylor Heart & Vascular Institute in Dallas. “This is medicine that’s being practiced right on the edge. Patients need to be aware of the situation.”

The valve, made partly from cow tissue, is inserted into an artery in the groin, and threaded using a thin wire into the heart. It’s designed to help patients who may be too frail to undergo surgery in which doctors cut open the chest, spread the ribs and temporarily stop the heart. It may also give a less invasive option with speedier recovery to healthier patients.

Results from the trial, called Partner, are one of two key pieces of information Edwards needs to win U.S. approval for Sapien. Data from a second group in the study who were healthy enough for open-heart surgery will be released in the first half of 2011.

Aortic Stenosis

Participants in the Partner trial suffered from narrowing of the heart’s aortic valve, or aortic stenosis, a condition affecting about 200,000 people in the U.S. Patients often experience fatigue and dizziness. Study patients had advanced cases of the disease and were too sick to undergo traditional surgery. About half of people with advanced cases will die in the first two years after symptoms appear, according to the study’s authors.

“Our experience with the valve has been quite favorable, even dramatic,” said William Fearon, a cardiologist at Stanford University Medical Center near Palo Alto, California. “I’ve seen patients before surgery who could barely get from the waiting room to the exam table without getting short of breath. I’d see them a month later and they could walk down the hallway without any shortness of breath.”

Edwards and Minneapolis-based Medtronic Inc. sell the less-invasive devices, known as transcatheter valves, in Europe. Medtronic is reviewing the final design of its U.S. trial for its device with the FDA, said Kathleen Janasz, a company spokeswoman.

Fewer Deaths

After a year, Sapien had 54 percent fewer deaths and hospitalizations than the traditional treatment, in a combined measurement that was a second main goal of the study.

Leon said strokes that happened in the first month after surgery were more likely tied to the device than those that occurred later in the study.

“In the face of a huge mortality benefit, the magnitude of these upfront risks is smaller,” said Laura Mauri, a cardiologist at Brigham & Women’s Hospital and Harvard Medical School in Boston, who wasn’t involved in the Sapien study. “It’s not a simple procedure. Over time, we expect these devices to become even safer.”

Several of the researchers reported receiving an undisclosed amount of speaking, consulting and other fees from Edwards, which funded the research. Leon, the lead researcher, was a founder of Percutaneous Valve Technologies, which developed the Sapien valve. Edwards bought the venture, in 2003, for $125 million.

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