Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective.
According to Forbes, 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.
This is not the first time that CardioMEMS attempts to receive PMA approval. In 2011 FDA rejected the Champion implantable monitoring system for heart failure for premarket approval, in part due to questions about the validity of presented data. Last year, CardioMEMS received an FDA Warning Letter.