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St. Jude Medical Announces Japanese Approval and Launch of VictoryFamily of Pacemakers

^{Published on 2008-11-17 05:52:42 - Market Wire}
 

ST. PAUL, Minn.--([ BUSINESS WIRE ])--St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), in addition to reimbursement approval, for its Victory® family of pacemakers.

Victory pacemakers are designed to promote more natural heart function, allowing the patient's own heart rhythm to prevail when possible by reducing the device's ventricular pacing using "smart pacing" technology. Called VIP® (Ventricular Intrinsic Preference), this technology actively monitors the heart on a beat-by-beat basis to provide pacing only when it is needed, which has been shown to be better for patients' overall heart health. Smart pacing also is an important clinical consideration because studies have shown that excessive right ventricular pacing may contribute to heart failure in some patients.

The Victory pacemakers, which are fully compatible with the St. Jude Medical Merlin® Patient Care System (the only cardiac device programmer available in the Japanese language), report all patient data in one concise "summary screen," which helps physicians quickly and easily interpret diagnostic information so they can best program devices for individual patient needs. The device stores information that is measured over time, so most standard follow-up tests already have been completed when a patient walks into the clinic. The test results are displayed with follow-up electrograms to verify the test findings, and detailed trend reports give physicians insight into a patient's cardiac status. The Victory pacemaker software also gives the clinician flexibility with multiple follow-up options and helps to extend the life of the device.

"Victory pacemakers offer significant advantages for patients and clinicians in Japan, including smart pacing technology that allows patients' hearts to beat on their own when possible and a more streamlined process for implant and follow-up procedures," said Paul Bond, chairman, St. Jude Medical Japan Co., Ltd. "Victory pacemakers were designed to provide physicians with the information they need to make better-informed decisions for their patient care."

The Merlin Patient Care System is the company's universal programmer for its pacemakers, cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs). The system allows physicians to quickly and efficiently program the Victory pacemaker at the time of implant and, if needed, re-program it at patients' follow-up visits.

Victory pacemakers are engineered to accommodate a wide variety of the diagnostic and therapy needs of patients, including algorithms that are designed to allow physicians to better manage patients with atrial fibrillation (AF). AF is the world's most common cardiac arrhythmia that results in a very fast, uncontrolled heart rhythm caused when the upper chambers of the heart (atria) quiver instead of beating.

Cardiac pacemakers are implantable devices used to treat [ bradycardia ], which is a heart rate that is too slow. These devices monitor the heart and provide electrical stimulation when the heart beats too slowly for each patient's specific physiological requirements.

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. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 13,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. 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 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 Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.