syringe in the midst of pulling vcr posts, page-10

shc competitor asx news. Sunshine announces successful preclinical trial at heart conference
Australia, Sydney. Sunday 24 October, 2004. Dr William Peters, Medical Director and
Chief Technical Officer of Sunshine Heart Inc (ASX:SHC), will today present a paper at the
conference of the Australasian Society of Cardiothoracic Surgeons in Noosa that describes
the positive findings of a 10-month pre-clinical trial of the company's heart assist device, CPulse.
C-Pulse devices were wrapped around the aorta (the main artery from the heart) of 26 adult
sheep which were then monitored for up to 10 months in a trial that showed the device to be
safe and capable of functioning continually for an extended period.
Close examination of the sheep at one, two, five and 10 months showed that the inner layers
of the artery were completely normal. Expected minor changes to the tissue of the artery wall
were seen in all sheep and signs of tissue repair were evident by 10 months.
C-Pulse was designed and developed by Sunshine Heart for the treatment of patients with
moderate to severe heart failure. One of the key features of C-Pulse that differentiates it from
other heart assist devices in use today is that the device helps the heart to pump blood
around the body without actually coming into contact with the blood at any time. Once CPulse
is implanted, it can be turned on and off as needed.
The C-Pulse is designed to be operated by a driver worn outside the body, attached, for
example, to a belt. The driver is linked by an air tube to the cuff of the device which
surrounds the aorta. The pulse-like action of the driver causes a balloon in the cuff to inflate
and deflate to the same rhythm as the heart, pumping blood at each cycle.
The low level of infection seen in the sheep trial was that expected from surgery such as this,
involving the implantation of a device.
The results of this trial have informed the planning by Sunshine Heart of a pilot clinical trial of
the C-Pulse in patients with moderate to severe heart failure, scheduled to commence in
New Zealand in December.
Heart failure is characterised by reduced capacity of the heart to pump blood, leading to
shortness of breath, limited ability to exercise, dizziness and fluid retention.