Clinical Trial Shows Device Optimizes Cardiac Resynchronization Therapy in Less Than Two Minutes; St. Jude Medical Announces QuickOpt Optimization Clinical Trial Results and European Regulatory Approvals at Cardiostim 2006.ST. PAUL, Minn. -- St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE See: New York Stock Exchange :STJ STJ Superior Tribunal de Justica (Brazil) STJ Supremo Tribunal de Justiça (Portugal) STJ Superconducting Tunnel Junction STJ San Giljan (postal locality, Malta) ) today announced the clinical trial results, receipt of European CE Mark approval and European market launch of its QuickOpt(TM) Timing Cycle Optimization. The trial results were presented by James G. Porterfield, M.D., principal investigator in the trial conducted under a U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE), during a late-breaking clinical trial session at Cardiostim 2006 in Nice, France. The IDE study found that QuickOpt optimization consistently was comparable to a traditional echocardiography Echocardiography Definition Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and (echo) procedure for determining optimal conduction delays. QuickOpt procedures in the study were completed within two minutes, while echo optimization typically takes between 30 and 120 minutes and requires a manual investigation by a technician. Results showed QuickOpt optimization correlated consistently with echo more than 96 percent of the time for both atrial-ventricular (AV) timing and for ventricular-ventricular (VV) timing. The study endpoint required a correlation greater than 90 percent. The prospective, multicenter trial evaluated 115 cases, including heart failure and traditional ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. patients. All patients were implanted with St. Jude Medical dual-chamber implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were evaluated using echo to determine the optimal setting for synchronizing the rhythm of the upper chambers (atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. ) and lower chambers (ventricles Ventricles The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues. ) of the heart, and for properly timing the pumping of the right and left ventricles. Patients then underwent the same testing using the QuickOpt optimization feature. "My initial experience with QuickOpt is impressive, consistently recommending similar programming when compared to echo. It is a fast and simple way to optimize timing, which has been shown to contribute to improved left ventricular performance," said Dr. Peter Sogaard of Gentofte University Hospital in Hellerup, Denmark, who was among the first to use the QuickOpt feature. Because echo can be expensive and time consuming, most heart failure patients do not undergo timing cycle optimization. QuickOpt optimization, which takes less than two minutes, allows efficient and frequent optimization during routine device follow-up visits, and is now clinically proven to be as effective as echo-based optimization. "Our goal is to provide patients and physicians with easier access to AV and VV timing optimization," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. Division. "With the QuickOpt feature, optimization can be performed quickly as part of the normal in-office follow-up visit, which should result in a greater percentage of patients undergoing optimization of timing intervals than when they need to be scheduled for a separate echo study." Other previously published studies, including a prospective pilot study and a retrospective study retrospective study, a study in which a search is made for a relationship between one phenomenon or condition and another that occurred in the past (e.g. comparing optimization methods, had findings similar to the clinical trial results. Several studies have evaluated the benefits of optimized cardiac device programming, showing improved quality of life and improvements in heart failure class (as measured by New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Heart Association standards) for patients. St. Jude Medical has filed a pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) supplement application with the FDA for programmer software with the QuickOpt feature. The FDA is currently reviewing the QuickOpt optimization clinical trial results and the software submission. The QuickOpt feature, available outside the United States on the St. Jude Medical Merlin(TM) Patient Care System and 3510 programmer, quickly provides information on a results screen. Clinicians can then accept or modify the recommended results and program the device accordingly. The QuickOpt feature is compatible with all St. Jude Medical multi-chamber ICDs. 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 10,000 people worldwide. For more information, please visit www.sjm.com. Forward-Looking Statements This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical success, regulatory approvals, anticipated future product launches, 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 the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and the cautionary statements described in the Company's Quarterly Report on Form 10-Q filed on May 9, 2006 (see pages 29-30). 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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