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50th implant of VentrAssist

Ventracor (ASX: VCR) today announced the 50th implant of its VentrAssist left ventricular assist device (LVAD). The implant of the 50th VentrAssist coincides with reaching the enrolment target of the 30th implant in the CE Mark Trial an important milestone on the path to regulatory approval.

The VentrAssist:

  • has been implanted, the Company believes, in more patients than any other third generation centrifugal LVAD in the world
  • is the only third generation centrifugal LVAD in a clinical trial in the US
  • is a leader among companies with third generation LVADs.

The VentrAssist has now been implanted in patients aged between 10 and 75 years in Australia, UK, the United States, Norway and New Zealand.

The longest duration implant of the VentrAssist to date is more than two years and the patient is doing well.

Ventracor Limited Chief Executive Officer, Dr Colin Sutton said: "Early completion of enrolment in the CE Mark Trial sets the stage for collating and submitting the data to support the application for CE mark approval to begin selling the VentrAssist in major European markets."

"Additionally, the 50th implant is a wonderful milestone. The VentrAssist has given new life and hope to a broad range of patients. The evidence to date is that the VentrAssist is meeting our expectations.

"Ventracor has moved down the track of the all-important clinical trials which are a prerequisite to obtaining regulatory approvals. We consider that we are well-positioned to take a significant role in the global market for LVADs.

"We have a strong competitive position with our product, and are well ahead of some other companies who have yet to announce any human implants, or initiation of a US clinical trial," Dr Sutton said.

"With sales of the VentrAssist product during the clinical trial in the US, and with CE Mark approval to sell expected late in 2006, Ventracor anticipates
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Contact: Andrew Geddes
61-294-063-086
Research Australia
9-Feb-2006


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