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FDAnews Device Daily Bulletin
Aug. 22, 2012 | Vol. 9 No. 165
Riata Leads Hit With 522 Request, FDA Urges X-Rays to Guide Patient Care
The FDA Thursday ordered St. Jude Medical to conduct three-year postmarket surveillance studies of its troubled Riata and Riata ST coronary leads to obtain data on the likelihood of premature insulation failure. According to the agency, the studies should look at the number of cases of insulation failure and whether the fraying was visible by X-ray, how soon following implantation the failure occurred and the time between implantation and lead malfunction. St. Jude must also examine whether adverse events are due to poorly functioning or failed leads.
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