Devices

FDA Approves Humacyte’s Symvess

FDA has approved Humacyte Global’s Symvess (acellular tissue engineered vessel-tyod) indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and autologous vein graft is not feasible. An agency statement says Symvess is the first acellular tissue engineered vessel to be approved for the indication. It says the current standard of care for patients with extremity vascular injuries can include procedures such as autologous vein grafting or implantation of a synthetic graft. Those treatments are not suitable or available for every patient, FDA says.

Symvess is described as a sterile, acellular tissue engineered vessel composed of human extracellular matrix proteins typically found in human blood vessels. It is manufactured using a tissue engineering process using human vascular smooth muscle cells derived from human aortic tissue, the statement says. It is a one-time, single-use product surgically implanted to replace a patient’s damaged blood vessel after a traumatic injury to the extremity.

Symvess’ safety and effectiveness were assessed based on data from a prospective study in 54 patients with life- or limb-threatening vascular trauma. The most common adverse reactions were thrombosis, fever, pain, and anastomotic stenosis. FDA says Symvess’ serious risks include graft rupture, anastomotic failure, and thrombosis.

“Because Symvess uses cells from a human donor and reagents of human and bovine origin, transmission of infectious diseases or infectious agents can occur,” the statement says. “The cells used in the manufacture of Symvess are derived from a donor who meets the donor eligibility requirements in place to prevent transmissible infectious diseases.”

The Humacyte BLA application was submitted in 12/2023 and received priority review, regenerative medicine advanced therapy designation, and designation as a priority product by the U.S. Department of Defense.

A company statement says the approval “is a transformational event for the company and our bioengineering technology platform. Even more importantly, we believe Symvess provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades.”

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