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St. Jude Medical Announces Publication of OPTIC Clinical Study Results in JAMA; Study May Hold the Key to Reducing Shocks in ICD Patients

Posted on: Tuesday, 10 January 2006, 18:00 CST

St. Jude Medical, Inc. (NYSE:STJ) today announced publication of the OPTIC (Optimal Pharmacological Therapy in Implantable Cardioverter Defibrillator Patients) clinical study results in the January 11 edition of The Journal of the American Medical Association (JAMA). The study, sponsored by St. Jude Medical, shows that patients with an ICD (implantable cardioverter defibrillator) reduced their chances of receiving any shock to 10.3% per year when taking the drug amiodarone combined with beta blocker, as compared with 24.3% for patients on sotalol alone, and 38.5% for patients on beta blocker alone. In addition, the amiodarone and beta blocker medical regimen reduced the chance of a patient having an inappropriate shock to only 3.3% per year.

ICDs deliver life-saving therapy by shocking the heart out of dangerous, potentially fatal arrhythmias (disturbances in normal heart rhythms), but the high-voltage shocks can be uncomfortable. In the OPTIC Study, amiodarone plus beta blocker significantly reduced appropriate, inappropriate and total number of shocks by suppressing ventricular tachycardia, sinus tachycardia and supraventricular arrhythmias. Antiarrhythmic drugs complement the role of an ICD, which does not prevent ventricular arrhythmias, but only treats them once they occur by means of high-voltage shock or anti-tachycardia pacing therapy.

"What the OPTIC Study makes clear is that, despite the ability of ICDs with advanced dual-chamber discrimination algorithms to reduce the occurrence of inappropriate therapies, the use of antiarrhythmic drugs can significantly reduce ICD shocks," said Stuart J. Connolly, M.D., principal investigator of the OPTIC Study and Director of Cardiology at McMaster University in Hamilton, Ontario, Canada. "Among this category of drugs, amiodarone is considerably more effective against shocks than sotalol."

Inappropriate shocks - a common complication of ICD therapy - are most frequently caused by the device's inability to differentiate between non-lethal heart rhythms and lethal arrhythmias such as ventricular tachycardias. While these inappropriate shocks are not physically harmful, they may be uncomfortable and upsetting to the patient.

"Effective strategies to reduce ICD shocks are desirable because they can improve patient quality of life and mental well-being," said Eric S. Fain, M.D., Executive Vice President of Development and Clinical/Regulatory Affairs for St. Jude Medical's Cardiac Rhythm Management Division. "Results of the OPTIC Study will benefit ICD patients, and the importance of this study is reflected by the prestigious, peer-reviewed journal in which it is published."

A randomized, controlled clinical trial, the OPTIC Study evaluated 412 patients at 39 clinical centers in the United States, Canada and Europe. Patients received a St. Jude Medical dual-chamber ICD within 21 days before randomization. Antiarrhythmic drug therapy began immediately after implant.

The OPTIC Study is another example of landmark clinical research sponsored by St. Jude Medical, which includes the DAVID (Dual-Chamber And VVI Implantable Defibrillator) Study, also published in JAMA, as well as DEFINITE (Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation) and DINAMIT (Defibrillator IN Acute Myocardial Infarction Trial), both published in The New England Journal of Medicine.

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, Minnesota, the Company employs nearly 10,000 people worldwide. For more information, please visit www.sjm.com.

Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Company's Quarterly Report on Form 10-Q filed on November 8, 2005 (see page 35). Actual results may differ materially from anticipated results.

Source: Business Wire

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