Sunshine Heart has announced an update on its COUNTER HF US pivotal study for the C-Pulse heart assist system. COUNTER HF is a prospective, randomised, multicentre, controlled study evaluating the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure.
The study was temporarily paused in March after four deaths in the treatment arm of the study. The deaths were adjudicated as not device- or therapy-related and the Food and Drug Administration (FDA) approved resumption of patient enrolment in the study.
Immediately following the FDA’s decision to approve enrolment to continue the COUNTER HF’s study, Sunshine Heart distributed material to all sites with the necessary documentation in order to achieve site Investigational Review Board (IRB) approvals. Currently, 12 sites have been reactivated which is approximately half of all previously activated sites. Sunshine Heart expects the majority of sites to be reactivated by the end August.
In addition, the company has announced the enrolment of its first two patients since the resumption of the COUNTER HF study. One of these patients was already reviewed by Sunshine Heart’s newly-formed Physician Subject Selection Committee.