Study: 1 in 10 recalled St. Jude Medical Riata lead coatings fail within 6 years

February 25, 2013 by Arezu Sarvestani

A Danish study of patients with St. Jude Medical's recalled Riata defibrillator leads concludes that 1 in 10 lead wires poked through their protective coating after an average of 5.1 years.

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Danish researchers reported this week that their latest studies of St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator leads found that 1 in 10 had poked through their coating in an average of just over 5 years.

The study included 298 Danish patients, representing "virtually every living patient in Denmark who received Riata defibrillator leads," according to Heartwire.

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Lead externalization, although troubling, does not necessarily result in failure to provide defibrillation therapy to the patient, researchers noted. Data released by St. Jude last year suggested that internal short circuits, which were more rare than the incidence of exposed wires, were potentially more dangerous than externalization.

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