Symvess is the first acellular tissue-engineered vessel approved by the U.S. Food and Drug Administration (FDA) for use in adult patients. It serves as a vascular channel for peripheral artery injuries for urgent revascularization settings. This procedure is required when surgery cannot be delayed, and a homologous vein graft cannot be used to prevent imminent limb loss.
Blood vessels or vascular structures such as arteries in the arm, rupture, and leading to life-threatening vascular trauma. This may result in severe complications like hemorrhage or embolism. When an artery in an extremity is damaged then surgery is required to restore the normal blood flow.
Until recently, the current standards of care for individuals suffering from vascular injuries in the extremities include surgical repair with the patient’s blood vessels (autologous vein grafting) or the placement of an artificial graft.
The approval today provides a vital alternative therapy for patients with vascular trauma, utilizing advanced tissue material innovation, said Peter Marks, M.D., Ph.D., director of CBER. “The FDA is committed to supporting innovative products that offer life-saving benefits for patients with chronic injuries.”
Symvess is an acellular tissue-engineered, sterile vessel containing human interstitial matrix proteins (ECM) which is found in the blood vessels. It is manufactured by using human aortic tissue-derived smooth muscle cells through a tissue engineering process. Symvess is a single-use product, and its implantation requires surgery to replace a damaged blood vessel due to a traumatic injury in an extremity.
“Our treatment options for the Trauma to the circulatory systemare limited and can be severe and life-threatening,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products, CBER. “The decision to approve this new therapeutic drugbased upon an advanced medical technology marks an important step forward in approaching a significant unmet medical need.”
In patients with life- or limb-threatening vascular trauma, the safety data and potency of Symvess were established in a prospective, single-arm, multicentre study. Symvess was used to restore peripheral arterial vessels in 54 patients. Primary patency (smooth blood flow present with no interference) and secondary patency (needs a minimum of one intervention to keep the blood flow) were evaluated 30 days post-implantation for both efficacies. At day 30, 36 (67%) patients maintained primary patency and 39 (72%) had secondary patency. Nine percent of patients (5/55) had to experience amputation of the treated limb just after their first 30 days and 8 of the (around 15%) patients experienced amputation after a total of three years, for their treated limb.
Most often seen adverse reactions to Symvess include pain, thrombosis, anastomotic stenosis (abnormal narrowing of blood vessels where the Symvess was attached), and fever. Symvess is associated with some dangerous risks of graft rupture, failed anastomosis, along with thrombosis. As Symvess uses human donor cells along with bovine and human reagents, diseases (e.g., infectious) or agents may be transmitted. Symvess cells are manufactured from donor material meeting the requirements to prevent maximum transmissible infectious disease risks.
FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation and Priority Review to the application. The US Department of Defense (DoD) designated the application as a Priority Product. Therefore, Public Law 115−92 authorized the DoD to request assistance from the FDA to expedite product development and FDA review of products to diagnose, treat, or prevent life-threatening disorders/diseases or conditions affecting U. S. military personnel.
The company that got FDA approval for Symvess was Humacyte Global, Inc.
Reference: Office. FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities. U.S. Food and Drug Administration. Published 2024. Accessed December 24, 2024. FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
