Abstract
Chronic venous insufficiency (CVI), owing to deep vein reflux (DVR) and venous obstruction, is widespread and associated with significant morbidity. The BlueLeaf System has been designed to treat patients with symptomatic CVI with evidence of DVR. The BlueLeaf device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant. This report describes the early outcomes of the initial 6 patients treated in the United States.
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