FDA Requests Modifications for Sunshine Heart’s Counter Heart Failure Study
Sunshine Heart plans to respond this week to the FDA request for protocol modifications for the clinical trial of its C-Pulse system for treatment of heart failure.
The Eden Prairie, Minn., devicemaker says the FDA did not raise any safety concerns, but did ask that the protocol include information on select minor items, the most important being the company’s plan to incorporate a physician subject selection committee.
The Data Safety Monitoring Board has recommended that the study continue, the devicemaker says.
On March 6, Sunshine Heart paused enrollment based on protocol that if more than three of the first 20 patients died for any reason, the devicemaker and the FDA establish new protocols before the trial would resume. An independent clinical events committee has ruled the four reported patient deaths were non-device related, the devicemaker says.
The multicenter trial is designed to test the system’s safety and efficacy in the treatment of NYHA Class III and ambulatory Class IV heart failure. A total of 388 patients meeting the study criteria were randomized to 40 clinical sites.
The C-Pulse system uses counter-pulsation balloon technology to reduce the left ventricle’s workload by pumping blood throughout the body and boosting blood flow to the coronary arteries.
The system has been granted investigational device status by the FDA and Health Canada. It received CE Mark approval in 2012. — Jason Scott