St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it 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.
“We take our responsibilities as a leading manufacturer of cardiac rhythm management devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and that they function safely and properly,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “We are pleased to enlist PHRI to perform an independent analysis and validation of the Optim insulated defibrillation lead data from these three very large, long-term registries.”
PHRI will convene a committee of independent physicians chaired by Dr. John Cairns, an internationally recognized expert in cardiology clinical trials, professor of Medicine and former dean of Medicine at University of British Columbia, who has no affiliations with the cardiac rhythm management industry. Additional committee members include Dr. Stuart Connolly, professor and director of the Division of Cardiology at McMaster University, Dr. Jeff Healey, associate professor of Cardiology at McMaster University, Dr. Andrew Epstein, professor of Medicine at the University of Pennsylvania and chief of Cardiology at the Philadelphia Veterans Administration Medical Center, and Dr. Christopher Buller, professor of Medicine at The University of Toronto and director of Cardiac Catheterization and Intervention at St. Michael’s Hospital.