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XVIVO Perfusion AB announces FDA Advisory Panel's decision that XPS with STEEN Solution meets requirements for HDE approval


Friday, 21 Mar 2014 03:00am EDT 

XVIVO Perfusion AB:Says Advisory Panel convened by FDA voted unanimously, by 10 votes to zero, that XPS System with STEEN Solution meets requirements for HDE (Humanitarian Device Exemption) approval.Announces it will initiate dialogue with FDA in near future to discuss labeling and post marketing study.Advisory Panel meeting was held March 20 in Maryland, the United States, at which Advisory Panel discussed XVIVO Perfusion’s HDE application for XPS System with STEEN Solution.Advisory Panel primarily discussed clinical data accumulated in NOVEL study.NOVEL study is steered by a protocol including XPS and STEEN Solution.Advisory Panel voted unanimously that XPS System with STEEN Solution meets requirements for HDE approval.