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Boston Scientific's response to deaths faulted

September 08, 2007|From Reuters

CHICAGO — U.S. health regulators charged Boston Scientific Corp. with inadequate record-keeping and reporting after the deaths of five patients who were implanted with an experimental device to treat a dangerous ballooning of the aorta.

The Aug. 30 warning letter from the Food and Drug Administration is another blow to Boston Scientific, which is struggling with a shrinking market and operating under a 2006 FDA warning related to quality management and other problems.

The Natick, Mass.-based company has until mid-September to address the FDA's concerns and provide documentation on two U.S. trials: an early-stage trial that involved 43 patients and a mid-stage trial that did not involve the implantation of the device, known as a stent graft, in the body's main artery.

The stent graft was designed to treat abdominal aortic aneurysms, which affect as many as 8% of people over the age of 65 and account for more than 15,000 deaths in the U.S. each year.

The clinical trials started in 2003 and ended in 2006, after Boston Scientific became aware of fractures in the device and scrapped the program.

A copy of the FDA letter obtained by Reuters said, "Two of these deaths had not been evaluated to determine if there was a relationship between the deaths and the investigational device."

There was no evidence that any follow-up information was requested or obtained from the clinical trial sites after the deaths, the letter said. The FDA also cited Boston Scientific for failing to report so-called adverse events, which include death and injuries, in the trial.

It characterized Boston Scientific's previous responses as inadequate.

"We have no evidence indicating any of the deaths were related to the stent graft fractures," Boston Scientific spokesman Paul Donovan said.

Boston Scientific shares closed 2 cents lower at $13.21.

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