Healthcare Industry News: cardiac resynchronization therapy defibrillator
News Release - January 31, 2007
Journal of Cardiovascular Electrophysiology Publishes Study on Time-Saving Approach to Optimizing Timing for Heart Failure and ICD Devices
St. Jude Medical's QuickOpt Feature Provides Reliable, Simpler Alternative to Traditional OptimizationST. PAUL, Minn.--(HSMN NewsFeed)--Clinical trial results showing the effectiveness of a new approach for optimizing cardiac devices will be published in the peer-reviewed Journal of Cardiovascular Electrophysiology (JCE) in February 2007. The study found that St. Jude Medical's (NYSE:STJ ) QuickOpt(TM) Timing Cycle Optimization is equivalent to traditional echocardiography (echo) in optimizing implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), but requires less time and effort.
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 echo - the present clinical standard - can be expensive and time-consuming.
In the study, QuickOpt correlated to echo procedures for determining optimal conduction delays more than 96 percent of the time for both atrial-ventricular (AV) timing and ventricular-ventricular (VV) timing. The study endpoint required a correlation greater than 90 percent to achieve statistical significance. QuickOpt procedures were completed within two minutes, while echo optimization typically takes 30 to 120 minutes and requires manual interpretation by a technician.
The study authors concluded, "A strong correlation between the IEGM (QuickOpt Timing Cycle Optimization) method and echocardiogram optimization was consistently observed for all analyses. It can be performed safely in the office during routine follow-up in less than two minutes using the programmer."
St. Jude Medical developed QuickOpt as an easy, practical and effective method for making the benefits of optimization more accessible to patients. In previous studies, 80 percent of heart failure and ICD patients have benefited from timing cycle optimization.
"As an easy, practical and effective alternative to traditional optimization methods, the QuickOpt method allows more patients access to the benefits of optimization," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division.
Dr. James H. Baker II of The Heart Group in Nashville, Tenn., and an investigator in the QuickOpt clinical trial, authored the manuscript published in the JCE (Study Title: Acute Evaluation of Programmer-Guided AV/PV and VV Delay Optimization Comparing an IEGM Method and Echocardiogram for Cardiac Resynchronization Therapy in Heart Failure Patients and Dual-Chamber ICD Implants). Initial results from the QuickOpt trial, which was conducted under a U.S. Food and Drug Administration Investigational Device Exemption, were presented at the Cardiostim 2006 international medical meeting in Nice, France.
With the push of a button, QuickOpt provides recommended programming values on a results screen. Clinicians can accept or modify the recommended results and program the device accordingly. Available worldwide on St. Jude Medical's Merlin(TM) Patient Care System and 3510 programmer, 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 more than 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, 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 March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Reports on Form 10-Q filed on August 7, 2006 (see Item 1A on page 32) and November 7, 2006 (see pages 31-32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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