Sydney, Dec 18, 2007 AEST (ABN Newswire) - Ventracor (ASX: VCR) today announced US Food & Drug Administration (FDA) approval to use the new version of its VentrAssist(tm) 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.
Contact
Graeme Fallet
Company Secretary and Chief Financial Officer
or
Andrew Geddes
Manager
Investor Relations
TEL: +61-2-9406-3100
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