Sunshine Heart (NSDQ:SSH) said last week that the FDA will let it resume a clinical trial of its C-Pulse heart failure device once the safety watchdog approves "minor protocol changes."
Eden Prairie, Minn.-based Sunshine Heart said April 16 that the safety watchdog "did not indicate concerns regarding safety of the device and requested the updated protocol include information on several minor items," including a proposal to incorporate a physician subject selection committee for its Counter HF trial.
Sunshine Heart shares plunged last month when the company halted enrollment in Counter HF after 4 patients died. The trial’s protocol requires it to stop enrolling subjects while it consults with the FDA if more than 3 of the trial’s 1st 20 patients die. All 4 of the deaths have now been independently determined non-device related, the company said.
"We are pleased the FDA has offered a collaborative process to enable the study to commence in a timely manner. We were prepared for these types of minor protocol modifications," president & CEO Dave Rosa said in prepared remarks, adding that Sunshine Heart expects to submit the amendments early this week.
The FDA approved Sunshine Heart’s Counter HF trial back in August 2012. The 388-patient study is designed to determine whether C-Pulse is safe and effective in treating NYHA Class III or early Class IV heart failure patients with ejection fractions of 35% or less who are taking medication and have been evaluated for cardiac rhythm management therapy.
SSH shares closed down 24.7% at $4.03 apiece March 6, the day it announced a temporary halt for Counter HF. The stock was trading at $4.18 per share in mid-afternoon activity today, down 21.9% since the trial pause and off 2.11% on the day.
