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CardioMEMS Completes CHAMPION Clinical Trial Study
Date:6/1/2010

ary artery implant and were then randomized to the treatment or control group before discharge.  Prior to enrollment in the CardioMEMS trial, these patients were being treated by heart failure specialists at leading centers and were receiving optimal drug, device and disease management therapy.

The reduction in the risk of a heart failure related hospitalization at 6 months was 30% and the impact on hospitalizations continued to increase over time, reaching 38% per year over the full duration of the trial.  The average patient follow-up was 15-1/2 months. The safety profile of the device was positive:  none of the implanted sensors needed to be removed or replaced and all were functioning throughout the course of the trial.

"Pulmonary artery pressure monitoring using the CardioMEMS CHAMPION pressure monitoring system represents our first meaningful improvement for the management of heart failure in nearly a decade," said Dr. Abraham. "We were pleased to see that the patient benefit was robust and durable and actually increased beyond the primary endpoint of 6 months; this is a key point for patients, doctors and the healthcare system.  

Dr. Adamson added, "The CHAMPION trial illustrates how close monitoring of patients with chronic heart failure can reduce the need for costly and dangerous hospitalization while improving quality of life. These trial results hold great promise for patients suffering from chronic symptomatic heart failure.

The CHAMPION wireless HF sensor is an innovative miniature device that is implanted into the patient's pulmonary artery using a simple, catheter-based procedure. The pulmonary artery pressure is then measured and displayed using the CardioMEMS proprietary electronic monitoring system. Following the procedure, patients perform wireless measurements of their pulmonary artery pressure fro
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SOURCE CardioMEMS, Inc.
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