Mayo Clinic proceedings
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Mayo Clinic proceedings · Jan 2024
Outcomes of Arterial Bypass With the Human Acellular Vessel for Chronic Limb-Threatening Ischemia Performed Under the FDA Expanded Access Program.
To report outcomes of the human acellular vessel (HAV) implanted for limb salvage through the Food and Drug Administration (FDA) Expanded Access Program for patients with chronic limb-threatening ischemia with no autologous conduit. ⋯ The HAV is a safe and effective "off-the-shelf" biologic conduit. This experience from the FDA Expanded Access Program in this population with few alternative limb salvage options will help guide regulatory deliberations for patients with lower extremity ischemia and no autologous bypass conduit options.