A Medical Device Daily

The bad news just keeps coming for Boston Scientific (Natick, Massachusetts) as the company received a warning letter from the FDA concerning safety violations, including failing to promptly report the deaths of five patients enrolled in clinical trials of a device used to treat abdominal aortic aneurysms (AAA). The two U.S. trials included an early stage trial that involved 43 patients and a mid-stage trial that did not involve the implantation of the device, called a stent graft.

The device was developed by TriVascular (Santa Rosa, California), a closely held company acquired by Boston Scientific in April 2005 (Medical Device Daily, April 19, 2005).

Two deaths occurred after Boston Scientific took over the company, according to the warning letter, issued Aug. 30.

The company failed to investigate the two deaths to determine whether they were caused by the stent grafts, according to the letter, signed by Timothy Ulatowski, director of the compliance office of the FDA Center for Devices and Radiological Health. At least 25 patients have been found to have stent grafts with cracks placed in them during studies, and the events weren't reported within the required deadlines, Ulatowski said in the letter.

"Two of these deaths had not been evaluated to determine if there was a relationship between the deaths and the investigational device or to determine if they would be considered to be an [adverse event]," the letter said.

Boston Scientific spokesman Paul Donovan told Bloomberg News that the company "has no evidence indicating any of the deaths were related to the stent-graft fractures." After the company learned of the cracks in October 2005, it conducted an investigation and decided to halt further clinical trials using the device in 2006. The trial for the device began in 2003.

"We take our responsibility for these trials and to these patients very seriously," Donovan wrote. "We are working with the FDA to resolve this matter."

The FDA also said the company didn't properly notify trial participants of the increased risks of stent fractures.

Boston Scientific has until late September to respond to the letter and provide documentation on the two U.S. trials related to the device.

Late Sunday, Morgan Stanley med-tech analyst Glenn Reicin wrote in a research report that the warning letter for the discontinued stent program itself isn't material, but does raise questions about Boston Scientific's ability to get the FDA to lift an existing corporate warning.

"We should note that the lifting of the corporate warning letter is essential to Boston Scientific, as the window to launch Taxus Libert ahead of Medtronic's (Minneapolis) Endeavor is narrowing," Reicin said.

The company is facing several other issues, including finding ways to pay off the massive debt it incurred with its $27.2 billion acquisition last year of Guidant (Indianapolis). It has since had weaker sales in its coronary stent and defibrillator businesses, its two largest units

In a bid to reduce debt and more closely target its core businesses, the company reported its intention to sell its cardiac, vascular surgery and fluid management business units (Medical Device Daily, Aug. 20/July 26, 2007). The company also recently disclosed that it was selling the auditory assets of Advanced Bionics (Valencia, California) while retaining the pain management assets of that company after a protracted legal struggle with that company's management (MDD, Aug. 13, 2007).

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