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19-08-2012 | Article

FDA recommends imaging for patients with recalled ICD leads


Full statement

medwireNews: The Food and Drug Administration (FDA) recommends that patients with Riata-brand implantable cardioverter-defribrillator (ICD) leads undergo X-rays or other imaging studies to check for lead abnormalities.

In 2010, manufacturers St. Jude Medical (St. Paul, Minnesota) stopped selling the leads, and in 2011 the company voluntarily recalled its Riata and Riata ST Silicone Defibrillation ICD Leads following reports that they were subject to both inside-out and outside-in defects in the silicone insulation.

In some cases the defects caused lead malfunction and externalization of electrical conductors, which can lead to inappropriate shocks, no shocks when required, and potentially life-threatening arrhythmias.

The FDA recommends that patients who have ICDs or implantable cardiac resynchronization devices with Riata or Riata ST leads undergo imaging studies to check for abnormalities in the lead insulation.

It adds that imaging studies will allow monitoring of at-risk patients and individualized treatment plans, which could involve removal of defective leads. The agency cautions against routine removal of the leads, but suggests carefully weighing the risks and benefits for individual patients.

The FDA has ordered St Jude Medical to conduct post-market surveillance studies to collect additional data about the potential hazards of lead failure.

"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, director of FDA's Center for Devices and Radiological Health, in a statement.

"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 healthcare professionals and patients get the data they need to better guide clinical management decisions," Shuren said.

In July 2012, St Jude Medical reported results of a study showing that larger diameter leads are more frequently subject to failure than thinner leads.

The investigators found that 24.0% of patients who received the 8F leads had externalized conductors, compared with 9.3% of those with the 7F leads; a significant difference.

By Neil Osterweil, medwireNews Reporter