FDA gives Ventracor trial conditional approval
Tuesday, 08 February, 2005
Ventracor (ASX: VCR) has received conditional approval from the US FDA for a feasibility study leading up to a full scale trial of its cardiac assist device as a bridge-to-transplant.
The proposed trial, which is subject to satisfaction of an FDA request for minor modifications to the trial design and additional clarification of design data within 45 days, is planned to take place in ten patients at five US transplant centres.
"The feasibility study will allow Ventracor to acquire initial safety data for the US market, refine its US trial protocol and assist in the training of US-based medical investigators who will implant the VentrAssist left ventricular assist system (LVAS) in the proposed wider US trial," said Ventracor CEO Colin Sutton.
"Our approval to begin a wider bridge-to-transplant (BTT) trial at transplant centres throughout the USA is conditional on completion of this feasibility study."
Following the feasibility study, the Columbia University Medical Center's International Center for Health Outcomes and Innovation Research (InCHOIR) in New York will conduct the larger trial at transplant centres across the US.
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