Ventracor implants fifth heart device in US
Tuesday, 31 January, 2006
Artificial heart company Ventracor (ASX:VCR) has implanted its fifth VentrAssist left ventricular assist system (LVAS) in the United States.
The implant is part of an FDA-approved feasibility study in 10 patients at up to five hospitals across the US which will lead to a submission for approval to market the device in the US. The latest procedure was performed by a team led by Dr Yoshifumi Naka at the Columbia University Medical Centre in New York.
"We are very excited about participation in the clinical trial of the VentrAssist. It is the only third generation centrifugal LVAD available for clinical trial in the US, and we look forward to seeing the results of the clinical trials," Naka said in a statement.
Ventracor CEO Colin Sutton said, "The US enrolment moving quite rapidly -- we are on track to complete recruitment this quarter and are delighted that Columbia is our second centre to be implanting in the US."
Ventracor conducted its first implant at the University of Maryland Medical Center in Baltimore in mid-2005.
"We have five hospitals that have approval to conduct trials," Sutton explained. "We will enrol as many centres as we need. When we switch to full pivotal trial we will rapidly enrol all centres."
About 130 patients will be recruited for the pivotal trial, which is likely to commence next year.
Ventracor expects the completion of recruitment this quarter in its CE Mark Trial of 30 patients implanted for six months, required for approval to sell the VentrAssist in Europe.
"We don't have too many more to complete enrolment. We may choose to enrol more than 30 for a safety margin or to keep the implants rolling. We have a lot of data and that represents a good opportunity to cut time off the process," said Sutton.
Ventracor received its first revenues from the reimbursement of the VentrAssist from the US in October last year. The device has now been implanted in nearly 40 patients globally.
Like many companies in the sector, Ventracor's achievements have not been reflected in its share price, after highs of AUD$1.62 in June 2005, Ventracor's price has fallen, and was at $0.975 at press time.
However, Sutton remains optimistic. "[Ventractor] represents a great buying opportunity. We are very excited about how the trials are going and the product is doing what we hoped it would," he said.
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