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St. Jude Completes Prelimnary Analysis on ICD Lead

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Analysis by Population Health Research Institute included in St. Jude Medical Bi-Annual Product Performance Report

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Manufacturing Group November 11, 2012

St. Jude Medical Inc.  a global medical device company, today announces 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 in the second edition of the 2012 St. Jude Medical Product Performance Report (PPR).

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% rate of all-cause insulation abrasion (includes all types of abrasion and other mechanical types of insulation damage)
--0.31% 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,” says 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 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.

“PHRI’s independent analysis of Optim-insulated defibrillation lead data continues to support the safety and reliability of our Durata leads,” says 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.

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