XVIVO Perfusion AB Release: NOVEL Trial Recruitment of Patients Complete, FDA Has Decided That an Expert Panel Meeting Will be Held Q1 of 2014
9/20/2013 9:30:19 AM
All 42 planned patients in Xvivo Perfusion’s American clinical trial using STEEN
Solution™ have received transplants. In the ongoing follow-up good clinical
results have been obtained. The patients are being followed up over a period of
one year. During a meeting with the FDA it was decided that the expert panel
meeting preceding the decision on HDE registration (Humanitarian Device
Exemption) will be held within four to five months.
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