Ventracor implants 50, reaches CE Mark trial enrolment target
Thursday, 09 February, 2006
Artificial heart company Ventracor (ASX: VCR) has implanted its 50th VentrAssist left ventricular assist device (LVAD) and has reached the enrolment target of 30 implants in its European CE Mark trial.
Ventracor implanted its first patient at the Alfred hospital in Melbourne in July 2003 and the VentrAssist has now been implanted in patients aged between 10 and 75 years in Australia, UK, the United States, Norway and New Zealand.
"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," said Ventracor CEO Dr Colin Sutton in a statement. "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." According to Sutton the longest duration implant of the VentrAssist to date is more than two years and the patient is doing well.
"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," Sutton said. In January Ventracor announced it had implanted its fifth VentrAssist in the US as part of an FDA-approved feasibility study in 10 patients which will lead to a submission for approval to market the device in the US.
Ventracor received its first revenues from the reimbursement of the VentrAssist in October 2005.
"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 significantly increased revenues in the future," said Sutton. "With average selling prices to date exceeding reported industry averages, the future looks bright for Ventracor. We also continue to invest in the future, particularly with clinical trials and development of future generation products."
Following yesterdays announcement Ventracor shares rose 32 per cent to close at $1.20. At press time Ventracor shares were trading at $1.18 down 2 cents.
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