News | April 06, 2012

St. Jude Medical Announces Third-Party Validation, Analysis of Leads Registry Data


April 6, 2012 — St. Jude Medical Inc. 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 more than 24,000 patient-years of data collected over the more than five years that the 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 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 the University of British Columbia, who has no affiliations with the cardiac rhythm management industry. Additional committee members include Stuart Connolly, M.D., professor and director of the division of cardiology at McMaster University; Jeff Healey, M.D., associate professor of cardiology at McMaster University; Andrew Epstein, M.D., professor of medicine at the University of Pennsylvania and chief of cardiology at the Philadelphia Veterans Administration Medical Center; and Christopher Buller, M.D., professor of medicine at the University of Toronto and director of cardiac catheterization and intervention at St. Michael’s Hospital.

The committee will function independently of the company, meeting with the company to initiate the project but conducting work in private. The committee will meet on an ongoing basis for at least two years to review data as it is collected. Data analysis would be performed on an ongoing basis with accumulating data and the results would be published in St. Jude Medical biannual product performance reports and made available on the St. Jude Medical website. The committee may also independently publish its findings.

For more information: www.sjm.com


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