MASSDEVICE ON CALL — When Medtronic (NYSE:MDT) in 2007 recalled its Sprint Fidelis defibrillator leads, what was designed as a comparative clinical study turned into a registry of already-treated patients, many of which were children.
The Sprint Fidelis leads were favored for pediatric uses because they were thinner, but a new study suggests that they devices, which were recalled after they were found to be prone to fracture, may fail more often in children than they do in adults.
In a prospective analysis of the Pediatric Lead Extractability & Survival Evaluation registry, researchers found that 1 in 3 Fidelis leads failed, representing 71% of all failures observed in the study, heartwire reported. That compared with a 14% rate of lead failure for the total study population.
The analysis included 878 pediatric patients who from 2005 to 2010 received 965 total leads, 300 of which were the Sprint Fidelis, according to the report.
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