Sunshine Heart device approved for human trials

Sydney medical technology company Sunshine Heart Ltd (ASX:SHC) has chosen cloudy Auckland as the venue for a long-term clinical trial that should gladden -- and reinforce -- the failing hearts of six patients.

Auckland City Hospital's medical ethics committee has approved the first trial of Sunshine Heart's world-leading heart-assist device, C-Pulse, and the first patient is expected to receive the implant next month.

The first clinical trial, designed to test the safety and performance of C-Pulse, is being conducted in Auckland rather than in an Australian Hospital because the device's inventor, Sunshine Heart medical director, Dr Will Peters, is a long-time Auckland resident.

C-Pulse has been designed for treating moderate to severe heart failure. The implant comprises a balloon-like inflatable cuff that encircles the upper aorta, that boosts blood flow to the heart and reduces its workload by squeezing the major artery in synchrony with the patient's own heartbeat.

Unlike other artificial-heart devices, C-Pulse is no contact with the patient's blood, minimizing shear forces that have caused blood clotting in patients implanted with other experimental artificial heart devices.

Peters developed C-Pulse to improve the lives of patients debilitated by moderate to severe heart failure -- patients experience a severe reduction in the heart's capacity to pump blood, resulting in shortness of breath, limited ability for exercise, dizziness and fluid retention.

C-Pulse's internal cuff is driven by air pressure from an external pump, typically worn on the belt -- the company believes that, with extended use, it may allow the patient's own heart to recover.

Peters said, "We are delighted to be able to work with the physicians at Auckland City Hospital in bringing this new technology into the clinic and offering hope to people in heart failure who have no other therapeutic options available."