FDA Approves Symvess, an Acellular Tissue-Engineered Vessel
By Elana Gotkine HealthDay Reporter
THURSDAY, Jan. 2, 2025 -- The U.S. Food and Drug Administration has approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to prevent imminent limb loss.
Symvess is a sterile, acellular tissue-engineered vessel composed of extracellular matrix proteins usually found in human blood vessels and is manufactured using human vascular smooth muscle cells derived from human aortic tissue. The one-time, single-use product is implanted surgically to replace a patient's damaged blood vessel after traumatic injury to the extremity.
The safety and effectiveness of Symvess was assessed in a prospective, single-arm, multicenter study involving 54 patients with life- or limb-threatening vascular trauma. Of the 54 patients, 36 (67 percent) and 39 patients (72 percent), respectively, retained primary patency (blood flow present without any intervention) and secondary patency (at least one intervention required to maintain blood flow) at 30 days after implantation. Five and eight patients underwent amputation of the treated limb within the first 30 days and by the end of study (month 36), respectively.
"Today's decision to approve a new therapeutic product based on novel medical technology represents important progress in addressing a significant unmet medical need," Nicole Verdun, M.D., director of the Office of Therapeutic Products in the FDA Center for Biologics Evaluation and Research, said in a statement.
Approval of Symvess was granted to Humacyte Global.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted January 2025
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