Dr. Robert Hauser, a cardiologist at Abbott Northwestern Hospital, released a report Tuesday suggesting that a coating material used in a St. Jude Medical heart defibrillator may be dangerous.
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His research suggests that a proprietary material used by St. Jude to coat wires that connect an implanted defibrillator to a patient's heart is breaking down prematurely and, in some cases, leading to failure of the device. The study was published by EP Europace, a British cardiology journal.
Last week, the F.D.A. took the unusual step of recommending that patients who had received an earlier generation of St. Jude leads undergo imaging tests to determine if the device is beginning to fail. It also ordered St. Jude Medical to conduct additional studies on both the older generation of leads, called the Riata, and the new generation of Durata leads.
The company has said its studies had shown that the Optim coating protected the leads from abrasion in 99.9 percent of cases.