St. Jude Medical's Durata Lead Shown to be Safe in Analysis
Published: May 10, 2013
St. Jude Medical Announces Results from Independent Analysis of Optim-Insulated Defibrillation Leads in Late-Breaking Clinical Trial Session at Heart Rhythm 2013
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the Population Health Research Institute (PHRI), an academic health science research institute, has conducted a further independent analysis of data received from ongoing prospective registries that monitor the performance of the Durata™ and Riata™ ST Optim implantable cardioverter defibrillator (ICD) leads. The analysis was performed by PHRI and the results were presented today during the late-breaking clinical trial presentations at Heart Rhythm 2013, the Heart Rhythm Society’s 34th Annual Scientific Sessions in Denver.
PHRI analyzed data from three actively monitored registries; the OPTIMUM, SCORE and SJ4 Post-Approval registries, all sponsored by St. Jude Medical. The combined data from these registries currently represents more than 11,000 leads implanted at 293 sites.
The findings from PHRI’s initial analysis of the combined Optim-insulated lead registries, for data collected through Feb. 28, 2013, include:
- 99.9 percent rate of freedom from all-cause insulation abrasion (includes all types of abrasion and other mechanical types of insulation damage) at five years
- 99.4 percent rate of freedom from all-cause mechanical failure (includes any insulation abrasion, conductor fracture, failure of a crimp, weld, or bond, or other mechanical failure) at five years
“Data from St. Jude Medical’s prospective, actively-monitored Optim lead registries have been thoroughly analyzed by PHRI and continue to demonstrate very low rates of insulation abrasion and mechanical failure,” said Dr. John Cairns, professor of Medicine and former dean of Medicine at University of British Columbia in Vancouver. “These prospective registries are well designed with pre-specified definitions for adverse events and a centralized reporting structure. They have now been independently adjudicated by PHRI.”
PHRI convened a committee of independent physicians chaired by Dr. John Cairns, an internationally recognized expert in cardiology clinical trials who has no affiliations with the cardiac rhythm management device industry, to perform the analysis. 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.
“St. Jude Medical is proud to sponsor the largest actively monitored lead performance evaluation ever conducted for an ICD lead family,” said Dr. Mark Carlson, chief medical officer and senior vice president of Research and Clinical Affairs for St. Jude Medical’s Implantable Electronic Systems Division. “We are pleased that PHRI’s independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads.”
The results are published beginning on page 257 of the first edition of the 2013 St. Jude Medical Product Performance Report (PPR), which will be released today on sjmprofessional.com. The committee will continue to meet on an ongoing basis to review data as it is collected, which will be reported in future PPRs.
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.
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 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 30, 2013. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Kate Stoltenberg, 651-756-3388
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