Global medical device company Sunshine Heart has announced results of the FDA-approved feasibility clinical trial for its C-Pulse System.
This system was implanted in 20 patients at 8 approved sites in North America. Eighteen patients in the trial had Class III heart failure, while 2 had Class IV heart failure. Results indicated that there were significant improvements in NYHA Class reduction, Quality of Life and Left Ventricular Ejection Fraction in the patients.
"The completion of the C-Pulse Heart Assist System feasibility trial demonstrates that C-Pulse has the potential to help the millions of moderate to severe heart failure patients who have limited, if any, therapeutic interventions available to them," said Dave Rosa, CEO of Sunshine Heart.
The company is also looking to receive FDA approval to conduct more clinical trials with this device.