The US FDA has approved the first acellular tissue-engineered vessel for adults with extremity arterial injury requiring urgent revascularization and when autologous vein grafts are not viable. It is manufactured using human vascular smooth muscle cells derived from aortic tissue and composed of human extracellular matrix proteins. Clinical evidence The safety and efficacy of the acellular tissue-engineered vessel were evaluated in a clinical trial involving 54 patients to repair an arterial vessel in the extremity.
About 67% of patients who received the engineered vessel retained primary patency, and 72% retained secondary patency at 30 days. Administration Single-use product Surgical implantation to replace an injured extremity artery. Contraindications – Avoid in patients with a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel)…
