|[November 08, 2012]
St. Jude Medical Announces Preliminary Third-Party Validation of Registry Data for Optim-Insulated Defibrillation Leads
ST. PAUL, Minn. --(Business Wire)--
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 completed a preliminary
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
independently by PHRI using St. Jude Medical databases and the results
are published beginning on page 240 of the second edition of the 2012
St. Jude Medical Product Performance Report (PPR), released today on
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 10,987 leads implanted at 293 sites.
The findings from PHRI's initial analysis of the combined
Optim-insulated lead registries, include:
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 conducted this independent analysis of the combined lead
registries and found that the rates of insulation abrasion and
mechanical failure of Riata ST Optim and Durata leads appear to be very
low," said Dr. John Cairns, professor of Medicine and former dean of
Medicine at University of British Columbia in Vancouver. "The strengths
of these registries are their prospective designs, the use of
pre-specified and standard lead failure definitions, and the
adjudication of all outcomes by expert personnel."
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
Cardioloy 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.
"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.
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,
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 (News - Alert), 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.
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