The Population Health Research Institute (PHRI) has performed an independent analysis of data received from ongoing prospective registries that monitor the performance of the Durata and Riata ST Optim implantable cardioverter defibrillator (ICD) leads.
Sponsored by St. Jude Medical, PHRI analyzed data from three actively monitored registries; the OPTIMUM, SCORE and SJ4 Post-Approval registries.
The combined data from these registries currently represents more than 11,000 leads implanted at 293 sites, according to St. Jude Medical.
The findings from PHRI's initial analysis of the combined Optim-insulated lead registries include 99.9% rate of freedom from all-cause insulation abrasion at five years and 99.4% rate of freedom from all-cause mechanical failure, at five years.
University of British Columbia Medicine dean John Cairns said that the data from St. Jude Medical's prospective, actively-monitored Optim lead registries have been thoroughly analyzed by PHRI and continue to demonstrate very low rates of insulation abrasion and mechanical failure.
St. Jude Medical Implantable Electronic Systems Division Research and Clinical Affairs chief medical officer and senior vice president Mark Carlson said, "We are pleased that PHRI's independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads."
