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New Boston Scientific warning letter

This article was originally published in The Silver Sheet

Executive Summary

Boston Scientific failed to notify participants in a clinical trial of the risks associated with stent fractures, according to an FDA warning letter issued to the firm Aug. 30. An agency inspection conducted in May at Boston Scientific Cardiovascular found "serious violations" related to a clinical trial of a stent-graft for treating abdominal aortic aneurysms (AAA), a life-threatening condition that causes a weakening of the aorta. In April 2005 the company acquired TriVascular, a private firm that was developing less-invasive medical devices and procedures for treating AAA. The 43-patient, Phase I safety trial, initiated in 2003 by TriVascular, was halted in 2006 by Boston Scientific after researchers observed fractures in numerous stent-grafts. FDA's warning letter also notes that Boston Scientific did not evaluate two deaths that occurred during the study to determine if they were related to the device. The agency has requested that the firm "provide documentation of a corrective action plan that will ensure that all [unanticipated adverse device effects] observed in clinical studies sponsored by Boston Scientific will be appropriately evaluated and reported.
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