ST. PAUL, Minn.--(BUSINESS WIRE)--Aug. 22, 2006--St. Jude Medical, Inc. (NYSE:STJ - News) today announced U.S. Food and Drug Administration (FDA) approval and launch of QuickOpt(TM) Timing Cycle Optimization. This new programmer feature is designed to help physicians improve patient outcomes for people with cardiac resynchronization therapy defibrillator (CRT-D) devices and traditional implantable cardioverter defibrillators (ICDs) by providing a programmer-based optimization method that provides comparable results to echocardiography (echo).
In less than two minutes, the QuickOpt feature electrically characterizes the conduction properties of the heart and uses an exclusive algorithm to calculate the optimal timing values. This allows for efficient and frequent optimization during routine device follow-up visits. In comparison, a typical echo optimization procedure takes between 30 and 120 minutes and requires manual interpretation by a technician.
Previous studies have shown that CRT and ICD patients can benefit from timing cycle optimization. However, few patients undergo optimization because echo - the current clinical standard - can be expensive and time-consuming. St. Jude Medical developed QuickOpt optimization as an easy, practical and effective method for making the benefits of optimization more accessible to more patients.
“Many patients may not have their CRT device or ICD optimized, meaning that they recognize some benefits, but may not realize all of the benefits these sophisticated devices can deliver. In those patients, it’s like running an air conditioner on a hot day with the windows open,” said Dr. Raffaele Corbisiero of the Deborah Heart and Lung Center, Browns Mills, N.J., investigator in the U.S. Investigational Device Exemption (IDE) clinical trial, and one of the first physicians to use the QuickOpt feature. “QuickOpt provides the accuracy of echo-based optimization without the clinic time it takes to schedule, perform and interpret an echo procedure.”
A recent FDA IDE study demonstrated that QuickOpt optimization correlates consistently with echo-based optimization more than 96 percent of the time for both atrial-ventricular (AV/PV) timing and ventricular-ventricular (VV) timing. The trial results were presented by James G. Porterfield, M.D., principal investigator, during a late-breaking clinical trial session at Cardiostim 2006 in Nice, France.
“As the only company to offer this feature to physicians and patients, our goal is to help ensure that all patients with devices can take advantage of optimization,” said Michael J. Coyle, president of St. Jude Medical’s Cardiac Rhythm Management Division. “QuickOpt has the potential to change clinical practice by providing patients and clinicians a fast, convenient and reliable way to quickly maximize the value of their devices, while potentially reducing healthcare costs.”
The QuickOpt feature, available worldwide on St. Jude Medical’s Merlin(TM) Patient Care System and 3510 programmer, quickly provides recommended programming values on a results screen. Clinicians can accept or modify the recommended results and program the device accordingly. The QuickOpt feature is compatible with all St. Jude Medical CRT-D and dual-chamber ICDs, including those which have been previously implanted prior to the availability of this innovative feature.
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 11,000 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 of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, 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 those described in the Company’s Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company’s Quarterly Report on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page 32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Contact: St. Jude Medical, Inc., St. Paul Investor Relations: Angela Craig, 651-481-7789 or Media Relations: Kathleen Janasz, 651-415-7042
Source: St. Jude Medical, Inc.
