- 0.06 percent rate of all-cause insulation abrasion (includes all types of abrasion and other mechanical types of insulation damage)
- 0.31 percent rate of all-cause mechanical failure (includes any insulation abrasion, conductor fracture, failure of a crimp, weld, or bond, or other mechanical failure)
“PHRI’s independent analysis of Optim-insulated defibrillation lead data continues to support the safety and reliability of our Durata leads,” said Dr. Mark Carlson, chief medical officer and senior vice president of Research and Clinical Affairs for the St. Jude Medical Implantable Electronic Systems Division. “We will continue to closely monitor the performance of our high-voltage leads in order to support our efforts to provide safe, reliable devices to physicians around the world.”The committee will continue to meet on an ongoing basis to review data as it is collected, which will be reported in future St. Jude Medical Product Performance Reports. 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, The Lancet, the Journal of the American Medical Association, the British Medical Journal, Circulation, the 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 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 29, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.