First Sunshine Heart device implant recipient dies

The first patient to receive Sunshine Heart's (ASX:SHC) C-Pulse heart assist device on May 4, has died from multi-organ failure, 11.5 weeks after the implant.

Sunshine Heart said the death is unconnected with the C-Pulse device.

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.

The patient had a 15 year history of heart failure, with concomitant diabetes in addition to chronic kidney and liver failure, and had been assessed as not suitable for heart transplantation. In May, Sunshine Heart reported that the operation to implant the device had been successful.

In the follow-up period of nearly three months no device-related complications such as stroke, infection, bleeding, re-operation or device failure were observed.

The process of implanting further C-Pulse devices in suitable patients in the pilot study will continue, said the chief investigative surgeon Dr Paget Milsom in a statement.

"This study is designed to primarily test the safety of the C-Pulse device in the treatment of heart failure. Such trials necessarily start with very sick patients," said Sunshine Heart's medical director William Peters in a statement.

"The device has shown itself to be able to be safely implanted without the need for the heart-lung machine, and that it provided counterpulsation support to the heart for nearly three months without any device-related complications," he said.