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St. Jude Medical (STJ) Faces Boon-or-Bust Verdict on Heart-Plug Studies


10/24/2012 8:06:50 AM

For two decades, doctors have used a dime-sized plug made by St. Jude Medical Inc. to close holes found in the hearts of stroke victims in a surgery that’s based largely on a medical theory. This week, they’ll learn if the hypothesis holds up. New data from two studies testing whether the surgery stops repeat strokes could either cripple sales for the device made by St. Paul, Minnesota-based St. Jude, or send revenue surging. The $20,000 procedure is done in about 9,000 patients a year. One in five adults are born with the hole, a flap-like opening between the heart’s upper chambers that’s largely symptomless. When found after a stroke, though, some doctors quickly close it under the theory that dangerous blood clots may migrate through the opening and into the brain. In 2010, that thought was challenged by a controversial study that opened a rift among doctors. The newest data, set to be revealed at a medical meeting, has taken from 9 to 12 years to gather. With positive data “everyone in the world will be looking for patients” to do the surgery in, said Gregg Stone, director of cardiovascular research at New York-Presbyterian Hospital/Columbia University Medical Center for Interventional Vascular Therapy. Negative results “will truly challenge” using the procedure “in any patient.”

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