The feasibility trial has been extended by 30 more patient at the request of VCR.
This was done prior to obtaining BTT approval. It was also done to ensure that they continue to implant while FDA assess the submission for approving the BTT trails.
These additional 30 implants WILL BE included/counted towards the number of implants required for the BTT trails.
This is a direct quote from a VCR official I spoke with last March (2007).
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