Riata/ST Silicone Leads Need Constant Monitoring

Riata and Riata ST cardiac leads that had previously been recalled have a lower rate of survival than other available leads, according to a new study.

Research led by Edmund Keung from the University of California, San Francisco found that the Sprint Quattro Secure and Endotak Reliance G/SG leads had five-year survival rates of 99.2 and 99.5 percent, respectively. Comparably, the survival rate of Riata/ST leads was found to only be 97.5 percent.

The survival rate of the Riata/ST lead was found to be higher than the Sprint Fidelis lead, which was recalled in 2009 for lead fracture concern.

St. Jude Medical released a medical device warning last year that showed a 0.63 percent all-cause abrasion rate on Riata/ST high-voltage leads. The advisory led to a Class I recall by the Food and Drug Administration in December 2011, reports MedPage Today.

The University of California research team did an electrical survival analysis of the Riata/ST, Quattro, Fidelis, and Endotak leads using the data of VA National Cardiac Device Surveillance Center. A failure rate of 0.67 percent was reported for Riata/ST leads, which was only better than Fidelis at 2.08 percent.

If you or someone you know has been harmed by an unsafe medical device, contact Sokolove Law for free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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