May 20, 2008 - Riata leads by St. Jude Medical showed very low adverse event rates for all categories of lead-related complications, with fracture rates of 0.09 percent, according to data collected from more than 680 physicians at more than 370 sites.
Presented by the study's lead author, Andrew E. Epstein, M.D., of the University of Alabama at Birmingham, at the Heart Rhythm Society's 29th Annual Scientific Sessions, results came from the largest actively monitored, multisite lead performance evaluation ever conducted for an ICD lead family. The data is from an analysis of four prospective studies, all with comprehensive data monitoring on the performance of the Riata lead family.
The studies analyzed the experience of 7,498 patients who were implanted with Riata leads as part of their implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) systems. All sites participating in the four studies (ACT, OPTIMUM, RHYTHM and PAS) were monitored.
The data showed that adverse event rates for all categories of lead-related complications were very low. Overall, the Riata leads' fracture rates were 0.09 percent (9 in 10,000), insulation damage rates were 0.13 percent (13 in 10,000, with no insulation failures exhibited in Riata leads utilizing Optim(R) insulation), perforation rates were 0.31 percent (31 in 10,000), and dislodgement rates were 0.88 percent (88 in 10,000). These adverse events rates are significantly lower than many previously reported rates in the medical literature on ICD leads.
The results from these studies are significant given the duration of follow-up, which was a median of 22 months for the four studies.
"St. Jude Medical is openly sharing this data so that physicians have better information upon which to make informed decisions in choosing a defibrillation lead, as well as information that may help to reduce the risks inherent in any medical procedure," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "We are committed to closely and continuously tracking the performance of our products so that physicians have reliable information that will lead to better care for their patients."
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