FDA Clears St. Jude Medical's QuickOpt Timing Cycle


June 29, 2007

June 29, 2007 – St. Jude Medical, Inc. today announced that the FDA and European CE Mark approvals to expand the capabilities of its Frontier II cardiac resynchronization therapy pacemaker (CRT-P) to include QuickOpt Timing Cycle Optimization, designed to provide 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.

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