Positive results from C-Pulse follow-up

Sunshine Heart (ASX:SHC) has revealed positive results from a 12-month and the first ever two-year follow-up from a North American feasibility trial of its C-Pulse Heart Assist System.

The results from a preliminary 20 patients provide a promising milestone in the road to gaining regulatory approval for the device in the US.

Sunshine Heart has presented 12-month extended follow-up efficacy data showing positive trends towards improvements in NYHA Class reduction, MLWHF Quality of Life scores and 6 Minute Hall Walk – all common assessment methods for treatments for heart failure.

These results build on positive trends established during the six-month follow-up, the results of which were presented in November.

Sunshine Heart also revealed it had just completed a two-year follow-up for the first patient to receive the C-Pulse system during the feasibility trial.

Dr Andrew Kao, a heart failure cardiologist at St Luke's Hospital, said the patient has experienced “an amazing recovery of function” since the device was implanted.

“The first time I met him, he could not walk or even say a few words without extreme perspiration and shortness of breath,” he said. “After C-Pulse implantation, he can do many more activities [and] can walk around comfortably.”

The C-Pulse system is designed to assist the heart's left ventricle by reducing the workload needed to pump blood through the body, while increasing bloodflow to the coronary arteries.

In March, the US FDA cleared Sunshine Heart to move forward with an investigational device exemption (IDE) application by conducting a more large-scale study. The agency made its decision after reviewing the initial results from the feasibility trial.

The company is also seeking CE Mark approval for the system, and expects to receive the nod from Europe in the second half of the year.

Sunshine Heart is headquartered in Minneapolis in the US, and has a subsidiary in Australia. It listed on the ASX in 2004, and the NASDAQ in February this year.

Sunshine Heart (ASX:SHC) shares had climbed over 20% from Monday’s open to $0.052 by Wednesday’s close.