Sydney, Dec 3, 2007 AEST (ABN Newswire) - Ventracor (ASX: VCR) today welcomed a major milestone in the growth of the worldwide industry for Left Ventricular Assist Devices (LVADs).
A US Food & Drug Administration (FDA) panel recommended conditional approval for US marketing of the Thoratec Heartmate II, a second generation axial flow LVAD.
Ventracor Chief Executive Officer Peter Crosby said: "This is the first of the new generation LVADs to win FDA approval, and we believe this will help to drive adoption of LVAD therapy for patients in end stage heart failure."
The Ventracor VentrAssist(tm) is a third generation centrifugal flow LVAD that is market released in Europe and Australia. The VentrAssist is the only other LVAD in both a Bridge to Transplant (BTT) and Destination Therapy (DT) clinical trials in the US.
The VentrAssist is the only third generation device, and the only centrifugal LVAD in clinical trials in the US. There is more clinical experience with the VentrAssist than all other third generation centrifugal pumps combined.
"The early clinical results of the VentrAssist compare very favourably with those of the Heartmate II and we are optimistic the US clinical trials of the VentrAssist will yield very positive results," Mr Crosby added.
There are now 15 US centres that have been trained and are ready to go, including eleven centres that have implanted the VentrAssist LVAD as part of the US BTT or DT clinical trials.
Contact
Graeme Fallet
Company Secretary
Andrew Geddes
Investor Relations
TEL: +61-2-9406-3100
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