Ventracor starts global trial with implant in Perth
Monday, 13 September, 2004
Ventracor (ASX:VCR) has begun a global trial of its VentrAssist device, with the implant of a patient suffering congestive heart failure at Royal Perth Hospital.
The global trial will be the largest for the device, and will ultimately incorporate 30 patients in Australia, New Zealand and the UK. It is a necessary step in Ventracor's bid to achieve a CE Mark for the device, which it needs before it can be sold in Europe.
Ventracor CEO Dr Colin Sutton said the trial protocol would allow "the greatest number of suitable patients to be recruited in the shortest possible time, despite national differences in medical practice".
He said he the company was aiming to achieve European sales by as early as the end of next year. "Traditionally, the regulatory path in Europe is faster, simpler and allows for broader application of the device," Sutton said.
Eight patients have been implanted at Melbourne's Alfred hospital since a pilot trial for VentrAssist was begun in 2003. The sixth implant was as a 'bridge-to-transplant' - a temporary measure in a patient awaiting a heart transplant. until then, the device had been implanted in patients who were so ill that they had no other option. Last month, Ventracor said it was readying to submit an Investigation Device Exemption application to the US FDA, which will allow it to conduct pivotal trials in the US. The company plans to submit the IDE by the end of 2004, and if all goes well will enter the clinic there early next year. It has appointed a New York-based clinical trials management group to manage the US trials.
Ventracor recently received notification from the US Centres for Medicare and Medicaid Services (CMS) that its pump would be classed in the same reimbursement category as heart transplants, increasing the reimbursement rates. Previously, heart assist devices were only approved as 'bridge-to-transplant' devices, attracting a lower reimbursement rate.
The Royal Perth surgical team was led by Dr Robert Larbalestier.
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