First Sunshine Heart device implanted

Doctors at Auckland City Hospital have conducted the first long-term implant of a Sunshine Heart (ASX:SHC) C-Pulse heart device in a 56-year old New Zealand man.

The 2.5 hour operation was performed last week without using a heart-lung bypass machine or stopping the heart.

The company said the patient was recovering and the device is working well.

The C-Pulse is designed to treat people with moderate heart failure. Such patients struggle to walk short distances, get short of breath with minimal exertion and are subject to frequent hospitalisation.

The treatment options for this category of people are limited as they are typically already on maximal drug therapy but are not yet sick enough to receive a conventional heart assist device such as a left ventricular heart assist device (LVAD).

"[C-Pulse] definitely increases blood flow around the body and definitely decreases the work the heart has to do," said Crispin Marsh, director of corporate affairs and co-founder of Sunshine Heart. "The expectation is that patients will feel better, the body will be functioning better and it would lead also to an expectation of longer life expectancy."

Marsh said that while the recently implanted device will remain in the patient for as long as he needs it, formal result testing will occur at three months and be completed at six months.

The primary endpoints of the trial are an improvement in quality of life, measured by New York Heart Association class, Minnesota Living with Heart Failure score, and six minute walk test at six months post-implant. Secondary endpoints are measures of heart size and function as determined by echocardiography, and measures of safety.

The company will aim to enrol up to 10 patients in the trial. Marsh said that Sunshine Heart has filed for ethics committee approval in Australia to extend the trial here and "by the end of the year we hope to be well progressed with enrolment."

Marsh describes the current trial as a "feasibility trial" which will feed into submissions to the FDA for regulatory approval in the US. He said that Sunshine Heart is aiming for CE Mark approval for C-Pulse to be well advanced by the end of 2006 and that FDA approval "wouldn't come before 2010".

C-Pulse consists of a cuff with a wrap that is secured around the aorta and a balloon that inflates and deflates in time with the heart's rhythm. A sensing lead then conveys the heart's electrical signals to an external wearable driver unit which pumps the balloon via an air tube to the cuff.

The C-Pulse differs from an LVAD in that it does not come in direct contact with the blood. It is smaller, less expensive, requires a less invasive surgical procedure and can be switched on and off.

"At the moment LVADs can only be implanted in a heart transplant centre," said Marsh. In comparison, the C-Pulse can be implanted at any hospital that performs heart surgery, he said.

If the C-Pulse device stops, the patient is not likely to suffer significant blood clots, putting the heart at risk. "With an LVAD there is very substantial risk that the patient will die," said Marsh.

Also, because the patients who can receive C-Pulse devices are in the moderate rather than severe heart failure category, they have a heart that is much more likely to be recovered, said Marsh.