Sunshine Heart (SSH) announced the company has received unconditional approval from the FDA to conduct an interim analysis of COUNTER FS. The COUNTER study is a randomized, multicenter trial evaluating the safety and efficiency of Sunshine Heart’s C-Pulse for patients suffering from Class III and early Class IV heart failure.
The interim analysis is crucial to Sunshine going forward as it reduce the total length of the study. Instead of the original 388 patients, the FDA is requiring only half the data (194 patients). If the interim results meet the statistical threshold, the company would theoretically achieve conditional FDA approval to market C-Pulse to the 1.5M American affected with Class III heart failure.
Dave Rosa, Sunshine Heart’s CEO states:
“Today's announcement i...