Response Submitted to PACE Affirming Performance of Riata Leads
ST. PAUL, Minn. -- Nov. 12, 2007--St. Jude Medical said that an article was submitted to Pacing and Clinical Electrophysiology (PACE) journal responding to an editorial concerning the Riata family of leads that is expected to be published on the PACE Web site today. The article, authored by Mark D. Carlson M.D., Roger A. Freedman M.D., and Paul A. Levine M.D., has been accepted and is expected to be published by PACE in the December issue.
In reaffirming the strong and well-documented performance and reliability of St. Jude Medical's Riata leads, the article includes data from St. Jude Medical's returned product analysis, as well as from previously unpublished active, prospective registries (ACT and OPTIMUM) showing that the incidence rate of perforation with Riata is below or at the low end of what has been reported in the clinical literature for incidences of perforation for transvenous defibrillation leads. A summary of the information in the article is available on St. Jude Medical's Web site at www.sjm.com or by linking to http://www.sjm.com/riataperformance.
"We take a conservative approach in evaluating the performance of our products," said Dr. Carlson, chief medical officer and senior vice president of clinical affairs in St. Jude Medical's Cardiac Rhythm Management Division. "While perforation is a well-known risk in all transvenous lead implant procedures, St. Jude Medical's Riata lead performance is strong as confirmed by the data from both product return analysis as well as through two large, active, prospective registries being conducted by St. Jude Medical. Based on its specific design elements and data analysis to date, we are confident that our Riata Optim family of defibrillation leads, which have been well received by the clinical community, will have the highest reliability yet."
"Perforations are attributable to one or a combination of factors including patient characteristics, the design characteristics of the lead, and implant techniques. As lead designs and implant techniques evolve, it is important that physicians and manufacturers continue to work together to ensure optimal patient outcomes," said Dr. Freedman, director of clinical cardiology and professor of medicine, University of Utah Health Sciences Center, Salt Lake City, Utah, and a member of the St. Jude Medical Independent Leads Medical Advisory Board.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.