HQ Team
December 23, 2024: Humacyte Global, Inc., a US-based bioengineering company, got the US regulator’s nod for its product Symvess, a surgical implant to replace a patient’s damaged blood vessel after a traumatic injury.
The US Food and Drug Administration (FDA) gave the green signal to the first acellular tissue-engineered vessel utilising human vascular smooth muscle cells derived from human aortic tissue, according to an FDA statement.
It can be used in adults as a vascular conduit for extremity arterial injury when urgent restoration of blood flow is needed to avoid imminent limb loss and autologous vein graft is not feasible.
Vascular trauma occurs when a blood vessel is injured such as a rupture of an artery in the extremities, which can lead to serious, life-threatening complications such as hemorrhage or blood clotting.
When damage to an artery in the extremity occurs, urgent surgical repair is needed to restore normal blood flow.
Autologous vein grafting
The current standard of care for patients with extremity vascular injuries can include procedures such as autologous vein grafting, surgical repair using the patient’s blood vessels, or implantation of a synthetic graft. These treatments are not suitable or available for every patient.
“Today’s approval provides an important additional treatment option for individuals with vascular trauma, produced using advanced tissue engineering technology,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
Symvess is a sterile, acellular tissue-engineered vessel composed of human extracellular matrix proteins typically found in human blood vessels.
It is a one-time, single-use product surgically implanted to replace a patient’s damaged blood vessel.
Vascular trauma
“Currently available treatment options are limited for vascular trauma, which can lead to severe and potentially life-threatening complications,” said Nicole Verdun, MD, director of the Office of Therapeutic Products in CBER.
“Today’s decision to approve a new therapeutic product based on novel medical technology represents important progress in addressing a significant unmet medical need.”
The safety and effectiveness of Symvess were assessed based on data from a study in patients with life- or limb-threatening vascular trauma.
A total of 54 patients received Symvess to repair an arterial vessel in the extremity. Efficacy was evaluated based on blood flow present without any intervention and secondary patency or at least one intervention required to maintain blood flow 30 days after implantation.
Amputation
Of the 54 patients evaluated, 36 (67%) retained primary patency, and 39 (72%) retained secondary patency at day 30.
Five patients (9%) underwent amputation of the treated limb within the first 30 days, and eight (15%) patients underwent amputation of the treated limb by the end of the study (month 36).
The most common adverse reactions of Symvess are thrombosis, fever, pain, and anastomotic stenosis (abnormal narrowing where the Symvess was sewn to the patient’s blood vessel).
The serious risks of Symvess include graft rupture, anastomotic failure and thrombosis.
Because Symvess uses cells from a human donor and reagents of human and bovine (cow) origin, transmission of infectious diseases or infectious agents can occur, according to the FDA.
