FDA approves acellular tissue engineered vessel as conduit for extremity arterial injuries
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Key takeaways:
- Symvess is a sterile, cell-free tissue engineered vessel made of human extracellular matrix proteins.
- Among 54 patients treated with Symvess, 67% retained primary patency and 72% retained secondary patency.
The FDA approved Symvess as a vascular conduit for extremity arterial injuries in adults when urgent revascularization is needed to avoid limb loss, and an autologous vein graft is not feasible, according to a press release.
“Today’s approval provides an important additional treatment option for individuals with vascular trauma, produced using advanced tissue engineering technology,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) of the FDA, said in the release. “The FDA remains committed to facilitating the development of innovative products that offer potentially life-saving benefits for patients with severe injuries.”
A sterile, acellular tissue engineered vessel composed of human extracellular matrix proteins typically found in human blood vessels, Symvess (Humacyte Global Inc.) is a one-time, single-use product surgically implanted to replace a patient’s damaged blood vessel after a traumatic injury to the extremity, the release noted.
Assessed in a single arm, multicenter trial in 54 patients with life- or limb-threatening vascular trauma, results showed 67% of patients retained primary patency and 72% of patients retained secondary patency at day 30 with use of Symvess. Within the first 30 days 9% of patients underwent amputation of the treated limb and 15% of patients did soby month 36, respectively.
“Currently available treatment options are limited for vascular trauma, which can lead to severe and potentially life-threatening complications,” Nicole Verdun, MD, director of the Office of Therapeutic Products in CBER, said in the release. “Today’s decision to approve a new therapeutic product based on novel medical technology represents important progress in addressing a significant unmet medical need.”
According to the release, Symvess received priority review, regenerative medicine advanced therapy designation and is designed as a priority product by the U.S. Department of Defense.
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