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The Human Acellular Vessel (HAV), also known as the Acellular Tissue Engineered Vessel (ATEV), is a bioengineered, decellularized vascular conduit developed by Humacyte, Inc. for use as a vascular access for hemodialysis in patients with end-stage renal disease (ESRD). The HAV is produced by culturing human vascular smooth muscle cells on a biodegradable scaffold in a bioreactor system for eight weeks. The resulting tissue is then decellularized to remove donor cells and antigens while preserving the extracellular matrix and biomechanical properties. Upon surgical implantation, the HAV is repopulated by the patient's own cells, transforming into a living blood vessel that is resistant to infection and provides superior patency compared to traditional synthetic grafts or autogenous fistulas. It was the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation.
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