QuickOpt optimizes cardiac resynchronization therapy in under two minutes

20 June 2006

Nice, France. A clinical trial of St Jude Medical's (NYSE:STJ) QuickOpt timing cycle optimization feature for its implantable defibrillators found that it was consistently comparable to a traditional echocardiography (echo) procedure for determining optimal conduction delays.

QuickOpt procedures in the study were completed within two minutes, while echo optimization typically takes between 30 and 120 minutes and requires a manual investigation by a technician.

The trial results were presented by James G. Porterfield, M.D., principal investigator in the trial conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), during a late-breaking clinical trial session at Cardiostim 2006 in Nice, France.

Results showed QuickOpt optimization correlated consistently with echo more than 96 percent of the time for both atrial-ventricular (AV) timing and for ventricular-ventricular (VV) timing. The study endpoint required a correlation greater than 90 percent.

The prospective, multicenter trial evaluated 115 cases, including heart failure and traditional ICD patients. All patients were implanted with St. Jude Medical dual-chamber implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were evaluated using echo to determine the optimal setting for synchronizing the rhythm of the upper chambers (atria) and lower chambers (ventricles) of the heart, and for properly timing the pumping of the right and left ventricles. Patients then underwent the same testing using the QuickOpt optimization feature.

"My initial experience with QuickOpt is impressive, consistently recommending similar programming when compared to echo. It is a fast and simple way to optimize timing, which has been shown to contribute to improved left ventricular performance," said Dr. Peter Sogaard of Gentofte University Hospital in Hellerup, Denmark, who was among the first to use the QuickOpt feature.

Because echo can be expensive and time consuming, most heart failure patients do not undergo timing cycle optimization. QuickOpt optimization, which takes less than two minutes, allows efficient and frequent optimization during routine device follow-up visits, and is now clinically proven to be as effective as echo-based optimization.

"Our goal is to provide patients and physicians with easier access to AV and VV timing optimization," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "With the QuickOpt feature, optimization can be performed quickly as part of the normal in-office follow-up visit, which should result in a greater percentage of patients undergoing optimization of timing intervals than when they need to be scheduled for a separate echo study."

Other previously published studies, including a prospective pilot study and a retrospective study comparing optimization methods, had findings similar to the clinical trial results. Several studies have evaluated the benefits of optimized cardiac device programming, showing improved quality of life and improvements in heart failure class (as measured by New York Heart Association standards) for patients.

St. Jude Medical has filed a pre-market approval (PMA) supplement application with the FDA for programmer software with the QuickOpt feature. The FDA is currently reviewing the QuickOpt optimization clinical trial results and the software submission.

The QuickOpt feature, available outside the United States on the St. Jude Medical Merlin(TM) Patient Care System and 3510 programmer, quickly provides information on a results screen. Clinicians can then accept or modify the recommended results and program the device accordingly. The QuickOpt feature is compatible with all St. Jude Medical multi-chamber ICDs.

St. Jude Medical, Inc. also announced receipt of European CE Mark approval and the European market launch of its QuickOpt Timing Cycle Optimization.

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