This article is more than 5 years old. Information may no longer be current.
FDA recommends imaging for patients implanted with Riata leads
Click Here to Manage Email Alerts
The FDA today recommended that patients with Riata and Riata ST leads undergo X-rays or other imaging alternatives to screen for abnormalities in the insulation surrounding the lead.
The agency’s recommendation is supported by several studies suggesting that routine imaging of the leads may detect previously unrecognized abnormalities within the insulation. X-rays or other imaging techniques will help health care providers develop individualized patient treatment plans, according to a press release issued by the FDA. The agency, however, is cautioning against routine removal of leads without careful evaluation of benefits and risks to the individual patient.
The FDA has also required the manufacturer, St. Jude Medical, to conduct 3-year postmarket surveillance studies to collect clinical data related to the potential for premature insulation failure. The studies must address the number of patients with evidence of insulation failure and whether the failure was detectable with X-ray imaging; how soon after implantation the lead insulation fails; the time between lead implantation and lead malfunction; and adverse events associated with treatment for failing or malfunctioning leads.
“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,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”
St. Jude Medical recalled the Riata and Riata ST leads in November 2011 after reports of premature erosion of the insulation around the electrical wires.