Boston Scientific Corp., the medical devices maker, received a warning letter from federal regulators about inadequate record keeping and reporting following the deaths of five patients in a clinical trial for an experimental device.
In an Aug. 30 letter, the Food and Drug Administration cited the Natick company for "objectionable conditions" observed during an inspection of trials for a "stent-graft" system designed to treat patients suffering from abdominal aortic aneurysms - a life-threatening condition that causes weakening and bulging of the body's main blood vessel. The tubular device made of metal and fabric was being developed by TriVascular Inc., a California company Boston Scientific acquired two years ago.
The FDA cited the company for failure to immediately follow up on several deaths to see whether there was any relationship between the deaths and the device. The company also allegedly failed to promptly notify regulators after at least two dozen of the stents fractured, and failed to provide clinical investigators with all the information they needed to look into any problems with patients, the FDA said. The FDA asked Boston Scientific to respond to the letter within 15 business days.
Boston Scientific spokesman Paul Donovan said there is currently no evidence the device led to any of the deaths. And he noted Boston Scientific stopped development of the device in 2006, when it was still in the early stages of clinical trials, so the letter doesn't affect any products on the market. Even so, the company said it is continuing to track participants in the early trials and investigate the deaths.
"We take our responsibility for these trials and to these patients very seriously," Boston Scientific said. "We are working with the FDA to resolve this matter."
In January 2006, the FDA slapped Boston Scientific with a more serious corporate warning letter that bars the company from introducing any products until it adequately addresses the agency's concerns. At the time, the agency cited the company's top management for failing to correct numerous ongoing problems.
In addition, Boston Scientific has recently faced a series of other setbacks, ranging from litigation following its acquisition of Guidant Corp. to uncertainty about the effectiveness of its line of drug-coated stents. The company's shares have been trading near a two-year low. They fell 2 cents to $13.21 yesterday.
Todd Wallack can be reached at firstname.lastname@example.org.