Healthcare Industry News: neuromodulation
News Release - June 28, 2007
St. Jude Medical Announces FDA and CE Mark Approvals Of QuickOpt Timing Cycle Optimization For Additional Heart Failure DevicesApproval provides timing-cycle optimization to more patients worldwide
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals to expand the capabilities of its Frontier® II cardiac resynchronization therapy pacemaker (CRT-P) to include QuickOpt(TM) Timing Cycle Optimization, giving physicians a new option to manage therapy for patients based on their individual needs.
The Frontier II device is the first heart failure pacemaker with QuickOpt Timing Cycle Optimization. In about 90 seconds, the QuickOpt feature recommends to physicians which A-V (atrial-ventricular) and V-V (ventricular-ventricular) timing values to use to program the devices. This allows physicians to frequently optimize devices as their patients' needs change over time.
Because heart disease is different for each patient, customizing device settings for each patient - called "optimization" - enhances device performance so that it works in the most efficient manner possible. However, few patients currently receive the full benefit of their devices because echocardiography - the current gold standard - can be expensive and time-consuming.
QuickOpt Optimization produces results clinically-proven to be comparable to echocardiography, but is significantly less costly and time-consuming. A typical echo procedure takes between 30 and 120 minutes and requires interpretation by a technician, whereas QuickOpt Optimization is performed during patients' regularly scheduled follow-up visits in about 90 seconds.
"With the expansion of QuickOpt Timing Cycle Optimization to CRT-P devices, I can now offer the benefits of V-V timing optimization to all of my heart failure patients, including those implanted with devices prior to the availability of the QuickOpt feature," said Claudio Bonometti, M.D., of Sansum Clinic in Santa Barbara, Calif.
Prior to regulatory approval, QuickOpt Timing Cycle Optimization was technically available on the device, but "turned off" for previously implanted Frontier II devices. With approval, the feature will be enabled, making optimized therapy available to current and new St. Jude Medical patients alike.
"Now that the QuickOpt feature is available for the Frontier II CRT-P, I can provide timing cycle optimization to all my pacemaker, ICD and CRT patients," said Mathias Meine, M.D., of University Medical Center in Utrecht, The Netherlands. "This results in a significantly increased number of patients receiving the benefits of timing cycle optimization while improving clinic efficiency and follow-up time."
The QuickOpt feature was validated in a clinical trial using implantable cardioverter defibrillator (ICD) and CRT-D patients and is now available from St. Jude Medical in applicable device segments. In addition to the Frontier II device, St. Jude Medical recently announced European CE Mark approval of QuickOpt for the Zephyr(TM) pacemaker and FDA and CE Mark approval of the Promote(TM) and Current(TM) ICD families with QuickOpt capabilities.
"Based on overwhelming customer acceptance of the QuickOpt feature, it will now be available in more of our devices," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "Having QuickOpt available in so many of our device families means that more St. Jude Medical patients than ever have access to the benefits of easy, practical and effective optimization."
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 more than 11,000 people worldwide. For more information, please visit www.sjm.com.
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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Report on Form 10-Q filed on May 9, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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