After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS received a mixed message from an FDA advisory panel on its CHAMPION HF Pressure Measurement System, an implantable sensor monitor to help guide treatment in patients with congestive heart failure. The panel voted unanimously that the device was safe, the majority said the benefits outweighed the risks, but the majority voted the device is not effective.
One panel member said it was difficult to connect the dots between use of the monitor and decreased hospitalization and lack of data on use in women, Forbes reports.
St. Jude Medical (STJ) invested $60 million in the medical devices company back in 2010, which gave STJ a 19 percent equity stake in CardioMEMS. STJ still has the option to buy CardioMEMS. Despite the innovative product and the excitement surrounding it, the FDA rejected the Champion implantable monitoring system for heart failure for premarket approval in 2011, in part due to questions about the validity of presented data. Last year, CardioMEMS received an FDA Warning Letter.
