The FDA orders St. Jude Medical to conduct a 3-year postmarket review on its recalled Riata and Riata ST defibrillator leads as well as 3 additional sets of leads not associated with the recall.
The FDA ordered St. Jude Medical (NYSE:STJ) to launch a 3-year postmarket review on its recalled Riata and Riata ST defibrillator leads as well as for its QuickFlex LV CRT, QuickSite LV CRT, Riata ST Optim and Durata leads.
That's bad news for the medical device giant, which has worked hard to distance its leads, especially the Durata, from the high-profile Riata recall.
The FDA slapped the cardiology device maker with a Class I recall on the Riata leads in December 2011 after the company said they failed more frequently than previously reported. St. Jude recalled the Riata leads after receiving reports of high rates of "insulation abrasion," which occurs when the leads' wires poke through their insulation. St. Jude started pulling the devices off the shelves a year earlier over the same concerns.
"The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients," FDA medical devices chief Dr. Jeffrey Shuren said in prepared remarks. "However, the agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the postmarket surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions."
The agency ordered St. Jude to collect data on the number of patients with insulation failure and whether the failures were detectable with X-ray imaging, as well how soon after implantation the leads failed, the time between implantation and failure and adverse events associated with treatment for failing leads.
The federal watchdog agency further advised that all patients with the recalled Riata leads undergo X-ray or other imaging to look for abnormalities in the wires that may lead to further problems.
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