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Impulse Dynamics Announces Pivotal Results at the American College of Cardiology Annual Meeting Late-Breaking Session
Date:3/29/2009

Long-Term Data Demonstrate The OPTIMIZER(R) System to be Safe and Effective

ORLANDO, Fla., March 29 /PRNewswire/ -- Impulse Dynamics (U.S.A.) Inc. announced today findings from the FIX-HF-5 study of its OPTIMIZER System at the 58th Annual Scientific Session of the American College of Cardiology in Orlando, Florida.

Previous studies have demonstrated safety and efficacy of the OPTIMIZER System's cardiac contractility modulation (CCM) signals when applied for three months. The FIX-HF-5 study was designed to test the longer term effects in the largest randomized study to date.

The study met its primary safety endpoint, which was a noninferiority demonstration of the composite of all-cause mortality and all-cause hospitalizations. In terms of efficacy, the results showed that, compared to the control group, patients treated with CCM signals over the other group had significantly improved exercise tolerance as judged by an increase in peak oxygen update (p=0.02) and an improvement in quality of life as judged by a reduction in the Minnesota Living with Heart Failure score (p<0.0001). Although the results did not meet the study's overall primary efficacy endpoint demonstrating improvement in ventilatory anaerobic threshold, it was met in a subgroup of the patients.

"We are pleased to report these longer term data that add to the growing wealth of knowledge showing the potential of CCM as a therapy for heart failure patients with no other options," said Dr. William Abraham, professor of internal medicine and director of the Division of Cardiovascular Medicine, Ohio State University Medical Center.

In a subgroup representing the "less sick" half of the study population (NYHA Class III with ejection fraction 25% and above), the study found even greater improvements not only in peak VO2 (p=0.001) and quality of life (p=0.003), but also in the primary endpoint of vent
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SOURCE Impulse Dynamics (U.S.A.) Inc.
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