Boston Scientific Receives FDA Warning Letter

In a new blow to Boston Scientific, the FDA has warned the medical device manufacturer that it committed "serious violations" following the deaths of patients involved in a clinical trial. The regulator claims the company failed to determine whether two of five deaths that occurred in patients implanted with a stent graft were caused by the device. It also allegedly failed to report the adverse events and did not request follow-up information from the trial sites following the deaths. Stent grafts were designed to treat abdominal aortic aneurysms (a ballooning of the aorta that kills over 15,000 Americans over 65 each year). Clinical trials began in 2003, but Boston Scientific halted them in 2006 when it discovered fractures in the stents. "We have no evidence indicating any of the deaths were related to the stent graft fractures," said Boston Scientific spokesman Paul Donovan. The company acquired the device as part of its April 2005 purchase of TriVascular; some analysts are speculating it will try to sell the unit to help pay down its acquisition last year of Guidant. Boston Scientific has 15 business days to respond to the FDA's letter.

Sources: Wall Street Journal, Reuters, Boston Globe
Commentary: Boston Scientific: A Buyout Waiting to Happen • Drug-Coated Stents Safer Than Thought -- Study • The Long Case for Boston Scientific
Stocks/ETFs to watch: BSX. Competitors: JNJ, MDT, STJ. ETFs: IHI

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