FDAnews Device Daily Bulletin


March 28, 2006

An independent panel commissioned last summer to review Guidant's handling of its failed heart devices said the company should form an external committee of experts to serve as advisers.

This advisory group would consult with Guidant on product performance and health-risk assessments, potential actions to be taken in case of device failures and malfunctions, and when and how to communicate with physicians and patients, the panel said.

The 12-member panel, headed by Robert Myerburg, professor of medicine and physiology at the University of Miami, presented its findings along with eight primary recommendations to Guidant's CEO James Cornelius and its board of directors.

Myerburg praised Guidant's efforts in moving toward more transparency and allowing the panel "unencumbered access to information" including documents, interviews and site visits during the review process.

"We found overall device reliability to be well within acceptable performance expected of devices of that type, but [that] internal and external communications methods burdened the company's ability to manage and communicate low-frequency malfunctions," Myerburg told Cornelius and the company's board of directors. Panel members were determined that the analysis and recommendations in the report would be "neither a whitewash nor a witch hunt" but a search for the facts, he added.

Controversy surrounding Guidant's heart devices began when problems first surfaced in May 2005, the report said. The increased attention resulted from a series of reports of previously undisclosed defects in one category of implantable products -- pacemakers and defibrillators -- manufactured by Cardiac Rhythm Management (CRM), an arm of Guidant.

Problems worsened when one previously identified defibrillator defect was linked to a death, although Guidant stated it "attempted to balance the benefit of disclosure against potentially negative consequences" and defended its "position of nondisclosure as medically appropriate," according to the report. Guidant issued a recall of the devices in June 2005. ()a href="http://www.fdanews.com/ddl" target=_blank>