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FDA Says Riata Lead Patients Need X-Rays | cialis online

FDA Says Riata Lead Patients Need X-Rays

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The U.S. Food & Drug Administration (FDA) says that Riata Lead patents need to undergo X-ray or other imaging on the implanted heart defibrillators.

The FDA now recommends that patients with St. Jude Medical implantable heart defibrillators with Riata and Riata ST leads should receive imaging to check for abnormalities in the insulation surrounding the lead—a wire attached to the device that is inserted into the heart.

St. Jude Medical stopped selling the leads in late 2010, recalling the leads in November 2011. As NewsInferno noted, St. Jude warned surgeons against the leads’ use following reports of premature erosion of the insulation surrounding the electrical conductor wires, so-called “insulation failure.” This defect can cause a defibrillator to emit unnecessary shocks to a patient’s heart and, even worse, to fail to emit a life-saving electrical impulse to the heart when needed. In December 2011, the FDA deemed St. Jude’s action a Class I medical device recall, its most serious designation. According to the company, as of 2011, about 79,000 Riata leads remained implanted in patients in the United States.

Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the patient’s heart to monitor its rhythms. ICDs and CRT-Ds can detect life-threatening abnormal heart rhythms and deliver an electrical shock to the heart to restore normal heart rhythms and typically have layers of insulation that protect electrical conductor wires inside the lead. Insulation failure may cause electrical conductors within the Riata leads to move within or to move outside the outer lead insulation, which may lead to lead malfunction and for the lead to deliver inappropriate or no shock therapy; this may cause potentially life-threatening abnormal heart rhythms.

The FDA noted that its recommendation is supported by several studies demonstrating that routine lead imaging may detect previously unrecognized abnormalities with the device’s insulation. These imaging techniques will also help health care providers develop individualized patient treatment plans. The FDA also warns against routine lead removal without conducting careful and individualized benefit and risk evaluation.

“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,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “However, the agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the post-market surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions.”

The FDA is also mandating St. Jude Medical to conduct three-year post-market surveillance studies—known as section 522 studies—to collect clinical data concerning the potential for premature insulation failure in Riata and Riata ST leads. The studies must address the number of patients with evidence of insulation failure and if that failure was detectable with X-ray imaging, how soon following implantation the lead insulation fails, the time between lead implantation and lead malfunction, and adverse events associated with treatment for failing or malfunctioning leads.

While current recommendations apply only to the Riata and Riata ST ICD and CRT-D leads, the FDA also is requiring St. Jude Medical to conduct post-market surveillance studies on its QuickFlex LV CRT, QuickSite LV CRT; and Riata ST Optim and Durata ICD leads, as well. St. Jude Medical voluntarily recalled and stopped selling its QuickSite LV CRT leads and QuickFlex LV CRT leads in April 2012 over insulation abrasion.

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