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.
The committee will function independently of the company; meeting with the company to initiate the project, but conducting its 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.About PHRI The Population Health Research Institute (PHRI) was founded in 1999 as a joint Institute of Hamilton Health Sciences Corporation (HHS) and McMaster University; it is now one of the largest and most cited academic cardiovascular research groups worldwide. The institute’s vision is to conduct large simple studies to address questions of international importance and relevance. Its research programs explore the causes and prevention of cardiovascular disease, diabetes, obesity and societal influences on health, perioperative vascular complications, and stroke. PHRI has conducted more than 50 global trials and epidemiological studies in more than 1500 centers in 83 countries, involving over 500,000 patients, leading to more than 800 publications in the last 10 years in prestigious medical journals such as The New England Journal of Medicine, Lancet, the Journal of the American Medical Association, British Medical Journal, Circulation, Journal of the American College of Cardiology and the European Heart Journal. Several of the discoveries made by scientists at the PHRI have influenced prevention and treatment practices worldwide. About St. Jude Medical St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.