Sunshine Heart Resumes C-Pulse Heart Assist System Trial Enrollment
Sunshine Heart announced Tuesday the resumption of patient enrollment in its C-Pulse heart assist system clinical trial, following FDA approval. In February, the FDA signed off on an interim analysis in the hopes of speeding up the approval timeline.
The devicemaker paused enrollment March 6 after four patients died. An FDA independent clinical events committee later ruled the deaths were non-device related.
The multicenter trial is designed to test the system’s safety and efficacy in the treatment of NYHA Class III and ambulatory Class IV heart failure. It plans to enroll a total of 388 patients across 40 clinical sites.
The C-Pulse system uses counter-pulsation balloon technology to reduce the left ventricle’s workload by pumping blood throughout the body and boosting blood flow to the coronary arteries. It has been granted investigational device status by the FDA and Health Canada, and received CE Mark approval in 2012. — Jason Scott