FDA Advisory Panel Does Not Recommend Approval of CardioMEMS' Champion System

December 8, 2011—CardioMEMS, Inc. (Atlanta, GA) announced that the US Food and Drug Administration's (FDA) Circulatory Systems Devices advisory panel voted against recommending approval of  the company's Champion heart failure monitoring system. The Champion system is a wireless, permanently implantable device that allows cardiologists to monitor heart failure patients from their homes.

According to the company, the panel voted 9 to 1 that the CardioMEMS technology is safe. However, a majority of the panel did not affirm that the system is effective and ruled that a reasonable assurance of the risks associated with the device outweighs the potential clinical benefits of the technology. CardioMEMS advised that the panel recommendations, although not binding, will be considered by the FDA as it reviews the premarket approval application for the Champion monitoring system.

Interventional cardiologist Jay Yadav, MD, who is Chief Executive Officer and Founder of CardioMEMS, commented, “While we are disappointed with today's outcome, we look forward to continuing discussions with the FDA to determine the best path forward. We believe this technology is a significant step forward in the management of heart failure patients.”

The company stated that its premarket approval application included data from its CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) clinical trial. William T. Abraham, MD, et al published the CHAMPION findings earlier this year in The Lancet, which was reported in Cardiac Interventions Today.

According to CardioMEMS, the CHAMPION trial demonstrated a 28% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 37% 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 met all of its safety and secondary efficacy endpoints, noted the company.