On 8 December, CardioMEMS announced that the US Food and Drug Administration’s (FDA) Circulatory Systems Devices advisory panel voted against the Champion heart failure monitoring system, the first wireless, permanently implantable device that allows cardiologists to monitor heart failure patients from their homes. While the panel agreed that the CardioMEMS technology is safe with a vote of 9-1, the majority did not vote positively that the system is effective and that reasonable assurance of the risks associated with the device outweigh the potential clinical benefits of the technology.
Today’s committee recommendation, although not binding, will be considered by the FDA as it reviews the pre-market approval application for the Champion HF monitoring system. CardioMEMS submitted a modular pre-market approval (PMA) application with the last submission completed in April 2011 based on data from its CHAMPION clinical trial.
CardioMEMS CEO and founder, Jay Yadav, 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 CHAMPION (CardioMEMS heart sensor allows monitoring of pressure to improve outcomes in NYHA Class III patients) clinical trial demonstrated a 28% reduction in the primary efficacy endpoint of heart failure hospitalisation rates at 6 months, and a 37% reduction in heart failure hospitalisation 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.