Sunshine Heart Inc. is persevering against patient-enrollment challenges to complete the COUNTER HF
pivotal U.S. trial of its unique C-Pulse heart-assist device for advanced heart failure and no other viable options.
Sunshine Heart Endures Slow Enrollment For C-Pulse Heart Failure Device
Sunshine Heart CEO David Rosa details the challenges of enrolling patients in a trial targeted specifically at patients with Class III heart failure. The firm hopes the study of the C-Pulse heart assist system can be completed by early 2016, but is also cooking up a plan to start submitting data to FDA before enrollment finishes.