The US Food and Drug Administration announced on Friday that Symvess, the first acellular tissue-engineered vessel, has received approval for use in adults with extremity arterial injury requiring urgent revascularization.

This device serves as a vascular conduit when autologous vein grafts are not viable. Vascular trauma in extremities can result in life-threatening complications like haemorrhage or blood clotting, requiring swift surgical intervention to restore blood flow. Traditional treatments, such as autologous vein grafting or synthetic grafts, are not suitable for every patient.

Symvess is a sterile, acellular vessel composed of human extracellular matrix proteins derived from human aortic tissue. It is a one-time, single-use product designed to replace damaged blood vessels after traumatic injury. The safety and efficacy of Symvess were evaluated in a prospective, single-arm, multicenter study involving 54 patients with life- or limb-threatening vascular trauma. Results showed that 67% of patients retained primary patency, while 72% maintained secondary patency at 30 days. However, 9% underwent amputation within 30 days, and 15% required amputation by the end of the study.