Sunshine Heart (NSDQ:SSH) shares plunged today after the company said it’s halting enrollment in a clinical trial of its C-Pulse heart failure device after 4 patients died.
Eden Prairie, Minn.-based Sunshine Heart said 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. Two of the 4 deaths have been determined to be unrelated to its device, the company said.
"The company has received study documentation from the sites that reported the most recent 2 deaths that these were also non-device related. Patients already in the trial will continue follow-up according to the protocol," according to a press release.
The FDA approved Sunshine Heart’s Counter HF trial back in August 2012. Today the company said the federal safety watchdog "has responded to Sunshine Heart’s notification and has advised the company to file an [investigational device exemption] supplement that discusses the reasons for the temporary study suspension and a plan for study resumption. A supplement carries up to a 30-day review period by the FDA and the company expects to submit the document by March 16.”
President & CEO Dave Rosa said the company is confident it can resolve the issue “in a very short timeframe."
"While the current data suggest these incidents are non-device related, we have decided that in the absolute interest of patient safety, having a temporary pause in enrollment is the right course of action while we work with the FDA to discuss the findings. We remain excited by the increasing number of patients who are being presented for study review and are pleased that the screening process for enrollment will continue while we resolve this matter," Rosa said in prepared remarks.
SSH shares were down 26.1% to $3.96 apiece today in mid-morning activity.