Sunshine Heart has reported positive results from the US Food and Drug Administration (FDA) approved feasibility clinical trial for its C-Pulse System.
The trial involved eight North American sites testing 18 patients with ACC/AHA Stage C, New York Heart Association (NYHA) Class III heart failure and two patients with ambulatory Class IV heart failure were implanted with the C-Pulse Heart Assist System.
Following a six month study, C-Pulse system produced statistically significant improvements in NYHA Class reduction, Quality of Life, and Left Ventricular Ejection Fraction that measures the heart’s pumping ability.
The primary safety measurements in the trial included device related death, neurological dysfunction (strokes), aortic disruption, myocardial infarction (heart attack) and major infection through six months.
One patient died due to complications of mediastinitis related to a sternal wound infection as a result of sternotomy at implant while no strokes, heart attacks or device related bleeding events had been reported.
Sunshine Heart CEO Dave Rosa said the company will seek FDA permission to initiate a pivotal trial in the US in 2012.