250th IMPLANT of VENTRASSIST® LVADSydney Australia 6 May 2008:...

250th IMPLANT of VENTRASSIST® LVAD
Sydney Australia 6 May 2008: Ventracor (ASX:VCR) today announced that there
have now been more than 250 patient implants of the VentrAssist® Left Ventricular
Assist Device (LVAD).
There are now 36 centres in ten countries worldwide that have implanted the
VentrAssist LVAD.
In the United States, clinical trials continue to gain momentum, with 59 patients
enrolled in the Bridge to Transplant (BTT) Clinical Trial and 26 patients enrolled in
the Destination Therapy (DT) clinical trial, in addition to the 28 patients implanted in
the US Feasibility Trial which is now complete. There are now 19 centres in the US
that have performed at least one implant of the VentrAssist LVAD, with 22 centres
trained and ready to go.
Commenting on the achievement, Ventracor Chief Executive Officer Mr. Peter
Crosby said: “Ventracor is pleased with the growing clinical confidence in the
VentrAssist LVAD that comes with increasing data from many patients with good
outcomes. The clinical results from the US feasibility trial that were presented at the
International Society of Heart and Lung Transplantation in April compare favorably
with all new generation LVADs.”
Mr. Crosby further added: “We also applaud the US Food and Drug Administration
(FDA) pre-market approval (PMA) of the first of the new generation rotary blood
pumps, and anticipate that this will help validate the enormous potential of the
worldwide LVAD market.”
Ventracor’s VentrAssist LVAD is a third generation centrifugal flow LVAD that is
market released in Europe and Australia. It is one of only two devices in the US
which has been implanted in both a BTT and DT clinical trial. There is more clinical
experience with the VentrAssist LVAD than all other third generation centrifugal
LVADs combined.