50th implant of VentrAssistVentracor (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.
- 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 significantly increased revenues in the future.
"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.
"We are proud Ventracor has been able to attract eminent specialists and a world class scientific advisory board (SAB) to join our team.
"This advisory board is working well and strengthens our ability to complete the clinical trial with the key centers for VentrAssist around the world.
"LVAD implantation is eligible for reimbursement during the clinical trial in the US, so Ventracor will generate revenues from this trial, Dr Sutton said.
"In the US alone, there are approximately 27,000 people each year who could benefit from a heart transplant, but fewer than 10 per cent will receive a transplant each year due to shortage of donors.
"New clinical guidelines suggest that LVAD therapy is now the standard of care for many of these patients, and we believe that VentrAssist, potentially, is a lifesaver for those individuals who need to wait longer for a transplant, or who may not be eligible for a transplant.
"The clinical trials to demonstrate this are well under way. In due course, we aim to earn a significant share of the potential $5 billion global market," Dr. Sutton added.
Ventracor's World Class Scientific Advisory Board
The Ventracor Scientific Advisory Board (SAB) has a wide base of skills and international experience with LVADs. It is a hands-on working group able to provide management with a high level and practical perspective to the business.
For further information, please contact:
Manager, Investor Relations
61 2 9406 3086
Colin Sutton PhD
Chief Executive Officer
61 2 9406 3100
Last reviewed: By John M. Grohol, Psy.D. on 30 Apr 2016
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