N@N

St. Jude Medical Announces Launch of QuickOpt Timing Cycle Optimization for Cardiac Resynchronization Therapy Defibrillators (C

^{Published on 2008-12-01 06:36:34 - Market Wire}
 

ST. PAUL, Minn.--([ BUSINESS WIRE ])--St. Jude Medical, Inc. (NYSE:STJ) today announced expanded approval from the Japanese Ministry of Health, Labour and Welfare for the QuickOpt® Timing Cycle Optimization feature in the Epic® HF and Atlas®+ HF cardiac resynchronization therapy defibrillators (CRT-Ds). CRT-Ds are implantable cardioverter defibrillators (ICDs) that help prevent sudden cardiac arrest and treat heart failure by synchronizing heart rhythms.

The QuickOpt capability allows physicians to easily test and optimize a patient's CRT-D to ensure that its pacing rhythm is customized to the individual patient's needs. This is important because heart disease is different in each patient, so optimizing the devices helps to ensure that each patient receives the full benefit of device therapy.

Optimized timing can increase the efficiency of the heart's ability to pump blood to the body. At a fraction of the time and cost of conventional echocardiogram-based optimizations, the QuickOpt feature can help physicians optimize more patients in less time through a simple procedure. In 90 seconds during a regular follow-up visit, the QuickOpt feature can recommend the optimal A-V (atrial-ventricular) and V-V (ventricular-ventricular) timing values to use in programming the devices.

"QuickOpt optimization gives me the ability to precisely program the device to meet each patient's specific needs for treating their heart failure," said Hiroshi Nakajima, M.D., of Itabashi Chuo Medical Center. "It allows me to check my patients' devices and adjust the timing whenever needed so that the therapy can be continuously optimized for each patient."

Traditional echocardiography (echo), while considered the gold standard for optimizing devices, is expensive and time-consuming. The QuickOpt feature produces results clinically proven to be comparable with those of echo, in 90 seconds instead of the 30 to 120 minutes required for a typical echo.

Clinical trial results showing the effectiveness of this approach for optimizing cardiac devices were published in the peer-reviewed Journal of Cardiovascular Electrophysiology (JCE) last year. The study found that St. Jude Medical QuickOpt Timing Cycle Optimization is equivalent to traditional echo in optimizing ICDs and CRT-Ds, but requires less time and effort. In the study, QuickOpt optimization correlated to echo procedures for determining optimal conduction delays more than 96 percent of the time for both A-V and V-V timing.

Heart failure is a progressive dysfunction of the heart's pumping action due to the heart's inability to contract or relax properly. For the heart to work correctly, the main pumping chambers (the ventricles) must beat in a coordinated manner. In some heart failure patients, this coordination may be interrupted. The right and the left sides fail to beat in synchrony (together) and can actually work against each other.

Cardiac resynchronization therapy delivers electrical impulses to heart muscle in the two lower chambers, or ventricles. Called biventricular pacing, this causes both ventricles to contract at almost the same time, like in a normal heart. The goal of CRT is to synchronize the two ventricles (RV and LV) for optimal contraction, improving the efficiency of each contraction of the heart and the amount of blood pumped to the body. This therapy helps physicians lessen the symptoms of heart failure for their patients and, in many cases, helps to stop the progression of the disease.

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.