Panel Backs CardioMEMS HF Device, But Questions of Efficacy Linger

An FDA advisory panel voted unanimously Wednesday that CardeoMEMS’ Champion heart failure monitoring system is safe for use in patients who have been recently hospitalized for heart failure, but split 4-7 on the issue of effectiveness and 6-4, with one abstention, on whether the benefits outweigh the risks. Still, analysts say approval is likely. Larry Biegelsen of Wells Fargo Securities said that while the vote wasn’t as positive as had been expected, it points toward a 2014 approval. He based his prediction on the overwhelming vote on safety and the somewhat positive vote on risk-benefit ratio, as well as the generally upbeat tone of FDA reviewers.
Devices & Diagnostics Letter