Persistence paid off for CardioMEMS, maker of a miniaturized implantable system for monitoring patients with heart failure. After several years, the company received FDA approval for its namesake device, which has opened the doors for its acquisition by St. Jude Medical.
The FDA first rebuffed CardioMEMS in 2011 when it acknowledged that the device met the primary effectiveness endpoint and the primary safety endpoints in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial but then questioned the clinical significance of the findings. The CHAMPION trial was designed to evaluate the safety and effectiveness of the device—a wireless system for remotely monitoring New York Heart Association Class III heart failure patients by gauging pulmonary artery pressure and heart rate—for the reduction in heart failure hospitalizations.
The FDA advisory panel revisited the application in 2013 after the company provided follow-up data and analyses. The FDA reported that the study enrolling 550 participants found that at six-months the rate of device or system-related complications was 1.4 percent with no explants, repeat implants or operational failures.
“The FDA believes that there is reasonable assurance that the device is safe and effective for heart failure management with the goal of reducing the rate of heart failure-related hospitalizations in certain patients,” the FDA wrote in its approval announcement. It is requiring a post-approval study.
In 2010, St. Jude Medical took a 19 percent ownership in CardioMEMS with a $60 million investment and an option for the remaining 81 percent of the company for $375 million. St. Paul, Minn.-based St. Jude Medical announced in concurrence with the FDA approval that it now will exercise the option.
The deal is expected to be completed in the second quarter of 2014.