VCR -- FDA approves home discharge for US patients
SYDNEY Australia, 17 November 2006 -- Ventracor (ASX:VCR) today announced that the US Food & Drug Administration (FDA) has approved the company's request to allow home discharge of patients implanted with the VentrAssist under the US Feasibility Trial.
Chief Executive Officer Peter Crosby said: "Until now, US VentrAssist patients have been required to remain in hospital or an intermediate care facility until heart transplant.
"Removing this requirement makes participation in the US Feasibility Trial more attractive to patients because they are able to return to their home once they are discharged by their physician."
"We expect this approval will be a catalyst for recruitment in coming weeks, and is a key step on the path towards meeting our previously announced milestone of commencement of enrolment in the US Bridge To Transplant (BTT) Pivotal Trial in early 2007," Mr Crosby said.
The FDA approval is conditional on the company making amendments to the labeling of the VentrAssist within 45 days, however the ability for patients to be discharged home is immediate.
Ventracor is a global medical device company which has developed an implantable blood pump, the VentrAssist left ventricular assist device (LVAD), as therapy for patients in end stage heart failure. Ventracor plans to bring the VentrAssist to the global market.
Further information, visit www.ventracor.com
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