Sunshine Heart put its U.S. pivotal clinical trial on hold after receiving reports of four deaths among the study’s participants.
The company initiated the COUNTER HF trial to evaluate the safety and effectiveness of its C-Pulse system as a treatment for patients with New York Heart Association class III and early class IV heart failure. The C-Pulse system works by assisting the left ventricle. Its ability to reduce the workload and boost blood flow potentially may keep the patient’s condition stable or even reverse the process as well as possibly improve symptoms and quality of life.
In keeping with FDA protocol, Sunshine Heart announced that it suspended enrollment after reports that more than three of the first 20 patients enrolled in the trial had died. The Eden Prairie, Minn.-based company added that two of the four deaths were deemed by an independent panel to be unrelated to the device. It added that the documents for the two most recent deaths also stated that the deaths were non-device related.
Sunshine Heart must file an investigation device exemption supplement with the FDA, which it expected to do before March 16. The FDA has a 30-day window to review the supplement.
The randomized clinical trial had enrolled nearly 100 patients by the first quarter of 2015, with an enrollment goal of 388 patients. Sunshine Heart said it will work with the FDA on a plan to resume enrollment.
The C-Pulse system received CE mark in Europe in 2012 but it remains an investigational device in the U.S. and Canada.