Sydney, Dec 19, 2007 AEST (ABN Newswire) - Ventracor (ASX: VCR) today announced CE Marking approval for the next version of the VentrAssist(tm) left ventricular assist device (LVAD) which allows it to be marketed and sold in Europe.
The US Food & Drug Administration (FDA) approved use of the new version earlier this week.
The new version VentrAssist (called LVA4) was first implanted in Australia under the Special Access Scheme (SAS) and an application for full approval is with the Australian Therapeutic Goods Administration for review.
Ventracor Chief Executive Peter Crosby said, "The enhanced VentrAssist will help us continue to meet the needs of our partner cardiologists and surgeons and help them achieve better clinical outcomes for their heart failure patients.
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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