This pause in enrolment is in accordance with the study protocol where in the event that more than three of the first twenty subjects pass away for any reason, including non-device related deaths, the company will work with the FDA to discuss a plan to resume enrolment.
To date, of the four reported patient deaths, two have been adjudicated by an independent Clinical Events Committee (CEC) as being non-device related. The Sunshine Heart has received study documentation from the sites that reported the most recent two deaths that these were also non-device related. Patients already in the trial will continue follow-up according to the protocol.
The FDA 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 Sunshine Heart expects to submit the document by 16 March, 2015.
“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 enrolment is the right course of action while we work with the FDA to discuss the findings,” commented Dave Rosa, president and chief executive officer of Sunshine Heart.