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High-voltage lead performance study shows positive results

St Jude Medical : 16 May, 2008  (Company News)
St Jude Medical has announced the results from the largest actively monitored, multi-site lead performance evaluation ever conducted for an ICD lead family.
The data presented is from an analysis of four prospective studies, all with comprehensive data monitoring on the performance of the Riata lead family. The analysis concluded that performance and reliability of Riata leads are excellent, based on data collected from more than 680 physicians at more than 370 sites.

The studies analysed 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; see below for a description of the studies) were monitored. To ensure the data were as accurate as possible, each patient's source records were individually reviewed to be certain that all lead-related complications (further sub-categorized as fracture, insulation damage, perforation or dislodgment) were reported.

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 utilising Optim 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 are believed to be the largest and broadest analysis of lead-related complications ever to be presented, especially with complete data monitoring, and unlike reports of single-centre experiences or case reports, should best represent real-world experience in a wide range of implanter's hands.

The results from these studies are particularly 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, MD, 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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