St. Jude Medical's ($STJ) now-recalled Riata and Riata ST cardiac defibrillator leads fail more often over the long-term than rival products, according to newly-published research. The news, featured in the journal HeartRhythm, reinforces the sense of urgency behind company's 2011 Class I recall of the products. Riata leads remain in about 79,000 patients.
As MedPage Today points out in its coverage of the research, scientists at the University of California, San Francisco completed their study prior to the recall. But it is an important work because it confirms concerns over the ICD leads' higher electrical failure rate, backing up subsequent studies with similar conclusions. The researchers urge providers to monitor patients who still have the Riata leads very carefully "in order to prevent inappropriate shocks or failed device interventions," according to the article. And they recommend using "large-scale remote monitoring" to keep an eye on these patients.
Another finding: The research team addresses the Riata recall fallout for patients who still have the lead. They note that placing new leads and abandoning the old ones without removing them appeared to be a safe option for patients based on about 18 months of follow-up.
According to the study, Riata leads experienced a 97.5% survival rate. That's much lower, for example, than the 99.2% rate generated by Medtronic's ($MDT) Sprint Quattro Secure leads and the 99.5% produced by Boston Scientific's ($BSX) Endotak Reliance G/SG leads, the story notes. At the same time, however, Riata leads' survival rate still landed higher than Medtronic's Sprint Fidelis, which placed at 89.6% and faced a 2009 recall because of potential for fractured leads. Researchers conducted their retrospective analysis involving 24,300 patients with remote transmissions from 2002 to 2012.
St. Jude said its implantable cardioverter-defibrillator product sales dipped 4% in the 2012 second quarter, dropping to $746 million. The company is also investigating Riata risks on its own.
- read the MedPage Today story
- check out the journal abstract