Sunshine Heart gets thumbs-up for Australian pilot study

Sunshine Heart (ASX:SHC) has received ethics committee approval to conduct implantations of its C-Pulse device in Australia at Southern Health Monash Medical Centre in Melbourne.

"Monash Medical Centre is a non-transplant hospital and it will be the first to validate another premise of our business model," said Sunshine Heart CEO Don Rohrbaugh.

"This is the next phase of expanding the pilot clinical trials into Australian centres", said Sunshine Heart medical director Dr William Peters. "We have been granted ethics approval for a maximum of four patients. However the first patient will be reviewed at three months before the second patient will be implanted. The Southern Health surgical team has been trained in Auckland and on site."

Rohrbaugh told Australian Biotechnology News that Southern Health Monash Medical Centre was one of two Victorian centres to be involved in the multi-centre program, with the second centre to be announced before the end of 2005. A centre in NSW is also expected to be announced in 2006. He said C-Pulse had advantages over other, similar devices in that it cost less to implant, was cheaper, and did not come into contact with blood, avoiding the risks of bleeding, infection, clotting, stroke and death.

The C-Pulse is made up of a cuff, similar to the cuffs used to test blood pressure, wrapped around the portion of the aorta just above the heart, outside the blood vessel, and includes a balloon that is inflated and deflated to help the heart force blood down the artery and around the body. A sensing lead transmits the heart's electrical signals to an external driver unit that causes the balloon to inflate and deflate in rhythm with the heart.

Two patients have been implanted with the device in New Zealand. The first patient died of multi-organ failure nearly three months after the operation, from unrelated causes, while the second patient had the device removed one month after it was implanted, after he developed a related infection.

"The company has learned a great deal from the first two patients -- from the autopsy of the first patient we found that there was no damage to the aorta. We know from the second patient that after a month there was substantial improvement in heart function. We also know the device can be turned on and off, which can't be done with other heart devices and that it can be removed safely. The safety and performance of the device gives us the impetus to carry on," said Peters.

"Once we have 6-10 patients we will submit an Investigational Device Exemption (IDE) application to the FDA for permission to do a randomised trial in the US," said Rohrbaugh.

Meanwhile, Ruth Flynn has been appointed to the newly created role of clinical affairs manager to manage the multi-centre clinical trials of the C-Pulse implant in Australia and New Zealand.