FDA Approves Humacyte’s Symvess: A Revolutionary Off-the-Shelf Artery Implant for Vascular Trauma Repair
FDA Approval:
The FDA has approved Humacyte's Symvess (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma in adults when urgent revascularization is needed and autologous vein graft is not feasible124.
Off-the-Shelf Solution:
Symvess is a bioengineered human tissue designed to be a universally implantable vascular conduit for arterial replacement and repair, available off-the-shelf without the need for further patient injury to obtain vascular repair material23.
Clinical Trials:
The approval follows positive results from the pivotal phase 2/3 V005 clinical trial, which demonstrated high rates of patency, low rates of amputation, and infection compared to synthetic graft benchmarks135.
Innovative Technology:
Symvess is grown from human vascular cells, rendered acellular, and can be implanted without immunosuppression, offering a significant advancement in trauma care by resisting infection and remodeling into native arteries35.
Commercial Launch:
Humacyte has a highly experienced sales team already recruited and trained in preparation for the commercial launch of Symvess4.
Sources:
1. https://www.pharmacytimes.com/view/fda-approves-symvess-for-treatment-of-extremity-vascular-trauma
2. https://evtoday.com/news/humacytes-symvess-ATEV-approved-by-fda-for-treatment-of-extremity-vascular-trauma
3. https://jamanetwork.com/journals/jamasurgery/fullarticle/2826564
4. https://humacyte.gcs-web.com/news-releases/news-release-details/humacyte-announces-fda-approval-symvesstm-acellular-tissue