announc

Approval to Use New Version VentrAssist in US Trials
SYDNEY, Australia, 18 December 2007: Ventracor (ASX: VCR) today announced US Food &
Drug Administration (FDA) approval to use the new version of its VentrAssistâ„¢ left ventricular
assist device (LVAD) in its US clinical trial program.
The new version VentrAssist (called LVA4) was first implanted in Australia under the Special
Access Scheme (SAS). Submissions have also been made for approval to use LVA4 in Europe
and Australia.
The LVA4 will be introduced to the US clinical trial sites as soon as each site’s own Institutional
Review Board (IRB) approves changes to the protocols to include the LVA4, and training can be
conducted.
Ventracor Chief Executive Peter Crosby said, “Ventracor has an active research and
development program to deliver a pipeline of new products in response to feedback and
suggestions from our customers.
“The LVA4 is the next delivery from that effort, and we continue to work on an improved external
controller and batteries, as well as a VentrAssist with a fully implantable rechargeable power
supply.�
The new version uses the proven VentrAssist blood pump with a thinner percutaneous lead (the
wire from the pump that goes through the skin) which it is hoped will lower the risk of infection.
It also has a replaceable external extension wire to the controller. This allows the external part of
the wire to be replaced in case of inadvertent damage or wear from normal long term use.
A new more flexible outflow cannula (the tube that directs blood from the pump to the aorta)
allows greater surgical flexibility for different patient sizes and conditions. Ventracor has also
updated the range of inflow cannulae sizes and surgical tools.