CardioMEMS may face headwinds in its efforts to commercialize its implantable pressure measurement system in heart failure patients. The FDA instructed Circulatory System Devices Panel members to review clinical trial data for a discussion on Dec. 8 to determine if the study adequately demonstrates safety and effectiveness.
In an addendum, the FDA wrote that the bio-research monitoring division reported that practices may have biased results as well.
CardioMEMS designed a wireless system for remotely monitoring NYHA Class III heart failure patients by gauging pulmonary artery pressure and heart rate. FDA approved a randomized controlled clinical trial in 2007. The CHAMPION trial tests whether managing heart failure with the use of the monitoring system reduces the rate of heart failure hospitalizations.
In an executive summary, the FDA wrote that CardioMEMS met the primary effectiveness endpoint and the primary safety endpoints but questioned the clinical significance of the findings.
“Given these concerns and that this device would represent the first market-approved permanently implanted monitor for the management of patients with advanced heart failure, FDA would like panel input on the overall risk/benefit profile and approvability of the device,” the agency concluded in the 55-page summary.
CardioMEMS has submitted a Premarket Approval Application with the FDA. The FDA requires that devices must meet its threshold for safety and effectiveness based on premarket data before it grants approval.