Sunshine Heart, a company with headquarters in Sydney, Australia and Eden Prairie, Minnesota, is touting results of an early clinical trial evaluating its C-Pulse System in patients with moderate to severe heart failure.
The device, an external aortic compression system, relies on balloon counter-pulsation technology to assist the left ventricle. As the balloon is inflated, it helps move blood to the coronary arteries; deflating it reduces the pumping power required from the heart.
The firm is looking forward to receiving further approval from the FDA to continue clinical trials.
Some details of study results from the announcement:
At eight North American sites (n=20), 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 on optimal medical management were implanted with the C-Pulse Heart Assist System. After six months follow-up, C-Pulse therapy produced statistically significant improvements in NYHA Class reduction (3.1+/-0.3 to 2.2+/-0.8, P=0.0001), Quality of Life (64+/-17 to 49+/-26, P=0.001), and Left Ventricular Ejection Fraction (28+/-5 to 31+/-7, P=0.04) which measures the heart’s pumping ability.
All but one patient remained unchanged or demonstrated improvement in NYHA, Minnesota Living With Heart Failure (MLWHF) quality of life and Six Minute Hall Walk (6MHW). In addition, four patients improved to NYHA Class I and two patients were permanently removed from therapy due to improvements.
Primary safety measurements included device related death, neurological dysfunction (strokes), aortic disruption, myocardial infarction (heart attack), major infection and any other device-related serious adverse event through six months. One patient died from complications of mediastinitis which was related to a sternal wound infection resulting from the sternotomy at implant. There were no strokes, heart attacks or device related bleeding events.
Press release: Sunshine Heart Announces Results of Its C-Pulse(R) Feasibility Trial at the Transcatheter Cardiovascular Therapeutics Conference
Product page: C-Pulse Heart assist system…
Flashbacks: First Clinical Trial Implantatation of C-Pulse Heart Assist System; The Sunshine Heart C-Pulse