Preparing for European market launchVentracor Limited (ASX: VCR) today announced the first patient has been implanted with the VentrAssist in a new study designed to build on clinical momentum from the CE Mark Trial and prepare for European market launch.
The BRACE study (Baseline Results And Cost Effectiveness) will add to the body of evidence for the performance of the VentrAssist left ventricular assist device (LVAD) in up to 10 new centres in Europe. The new centres are in addition to the current Australian, NZ and European sites.
The BRACE study is a key component of Ventracor's commercialisation strategy to rapidly grow revenues after the anticipated CE Mark approval in early 2007.
The cost effectiveness results of the BRACE study will also be used to help obtain or increase reimbursement in key European markets.
After approval by the Regional Hospital Ethics Committee in Oslo, Norway, the first patient in the BRACE study, a 16 year-old girl was implanted last week.
Principal Investigator Dr Arnt Fiane at Rikshopitalet - Radiumhospitalet Medical Centre said: "We are excited about participating in the BRACE study for this potentially world-leading life-saving technology." Dr. Fiane added the patient was making a satisfactory recovery.
Ventracor Limited Chief Operating Officer Peter Crosby said: "We are very conscious that regulatory approval does not immediately equate to market acceptance.
"The BRACE study builds on the CE Mark Trial to expand clinical knowledge and understanding of the VentrAssist."
"By the time the VentrAssist receives CE mark approval later this year, we expect to have many more centres implanting the VentrAssist under the BRACE protocol and we can rapidly move to grow revenues from this established customer base.
"There have now been more VentrAssist third generation (3G) centrifugal LVADs implanted than all third generation centrifugal pumps from all our competitors combined," Mr Crosby said.
The BRACE study protocol was developed with Ventracor's global clinical investigators, statistical consultants and international Scientific Advisory Board. It has a similar inclusion and exclusion criteria to the successful CE Mark Trial and will gather data on long-term and short-term patient outcomes.
Ventracor is a global medical device company which has developed a blood pump, the VentrAssist left ventricular assist device (LVAD) for patients in heart failure. Ventracor plans to bring the VentrAssist to the global market.
For further information, please contact: Andrew Geddes Manager, Investor Relations Ventracor Limited + 61 2 9406 3086
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