Ventracor recalls external components of VentrAssist
Thursday, 08 September, 2005
Artificial heart company Ventracor (ASX:VCR) has recalled the external components of its VentrAssist left ventricular assist system (LVAS) following the discovery of an anomaly in certain lots of the cable which connects the externally worn controller to the implanted VentrAssist blood pump.
"It is a simple and inexpensive modification to the controller of less than 30 patients," said Ventracor CEO Colin Sutton. "We are treating this urgently - as it has the potential to cause problems we are hoping to avoid. We are half way through the Australian patients and by the end of next week hope to have changed the controller of all patents."
Ventracor is currently undertaking a global trial program aimed at the approval of VentrAssist for sale in Europe and in the US.
Sutton believes the recall will have a minor effect on the company's future milestones, "There will be delays as we rework the product but we don't believe they will be excessive but it will put under pressure the attainment of the CE trial milestone. That milestone is the recruitment of 30 CE Mark trial patients by the end of the year -- we are a lot more than half way through but we are under pressure," he said.
ABN Amro Morgan senior research analyst Scott Power is untroubled about the effects of the recall, "It's a minor bump in the road for Ventracor -- it's not helpful for the company but they are acting quickly to reduce harm to patients. Its all part of the clinical trial process."
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