St. Jude (STJ) Picks Independent Research Firm for Two ICD Leads Evaluations
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St. Jude Medical, Inc. (NYSE: STJ), has appointed Population Health Research Institute (PHRI), an academic health science research institute, to analyze data from three combined registries on the Riata™ ST Optim and Durata™ implantable cardioverter defibrillator (ICD) leads. The analysis will be entirely under the control of PHRI, who will complete a review of the performance of the leads.
Under the agreement, PHRI will receive the raw data, and independently design and perform analyses, from three ongoing prospective, actively monitored registries monitoring the performance of the Riata ST Optim and Durata leads; the OPTIMUM, SCORE and DF4 Post-Approval studies, all sponsored by St. Jude Medical. The combined data from these studies currently represents over 10,000 leads implanted at 292 sites, with over 24,000 patient-years of data collected over the more than five years that these leads have been on the market.
Under the agreement, PHRI will receive the raw data, and independently design and perform analyses, from three ongoing prospective, actively monitored registries monitoring the performance of the Riata ST Optim and Durata leads; the OPTIMUM, SCORE and DF4 Post-Approval studies, all sponsored by St. Jude Medical. The combined data from these studies currently represents over 10,000 leads implanted at 292 sites, with over 24,000 patient-years of data collected over the more than five years that these leads have been on the market.
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