The Lancet publishes CHAMPION trial results against heart failure

The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial was published online today in The Lancet. CHAMPION demonstrated a 30% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 39% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment. The CHAMPION Trial also met all of its safety and secondary efficacy endpoints.

The CHAMPION trial was a randomized, prospective, multicenter, controlled trial that enrolled 550 patients at 64 leading heart centers in the U.S. The trial was led by Dr. William Abraham at the Ohio State University Medical Center and Dr. Philip Adamson at the Oklahoma Heart Hospital. It evaluated the safety and effectiveness of CardioMEMS' heart failure pressure measurement system in New York Heart Association Class III (NYHA Class III) heart failure patients. NYHA Class III patients represent approximately 30% of the over six million heart failure patients in the U.S. and account for nearly half of all heart failure hospitalizations.

All subjects in the CHAMPION trial had the CardioMEMS heart failure sensor permanently implanted in the pulmonary artery using a simple, catheter-based technique. All patients took daily pulmonary artery pressure readings from home that were transmitted to CardioMEMS' secure patient database. For patients in the treatment group only, healthcare providers were provided access to the pressure readings which were used in the treatment of their heart failure condition. For control group patients, health care providers were denied access to the pressure readings and they continued to receive standard care.

"The results from the CHAMPION study are very significant and provide a valuable new tool in the battle against heart failure. Pulmonary artery pressure monitoring is the first major device breakthrough in heart failure since CRT therapy," said William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.

Dr. Adamson, director of the Heart Failure Institute at the Oklahoma Heart Hospital, 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 results are the beginning of a new era of hope for patients suffering from chronic symptomatic heart failure complementing medical and device therapies. The 'Hemodynamic Era' is a major advancement with promise for profound long-term impact on heart failure morbidity."

"Hospitalizations are very traumatic for heart failure patients and costly to the health care system," said Jay Yadav, M.D., founder and CEO of CardioMEMS and a cardiologist at the Piedmont Heart Institute. "With the CardioMEMS heart failure monitoring system, frequent hemodynamic monitoring can allow doctors and nurses to more efficiently manage their patients and produce meaningful reductions in their patients' heart failure related hospitalizations."

In September of 2010, St. Jude Medical invested $60 million in CardioMEMS in exchange for a 19% equity ownership interest and an exclusive option to acquire the remaining 81% of CardioMEMS for an additional $375 million during a period that extends through the completion of certain commercialization milestones.