Symvess FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 29, 2024.
FDA Approved: Yes (First approved December 19, 2024)
Brand name: Symvess
Generic name: acellular tissue engineered vessel-tyod
Dosage form: for Surgical Vascular Implantation
Company: Humacyte, Inc.
Treatment for: Revascularization Procedures
Symvess (acellular tissue engineered vessel-tyod) is a first-in-class, implantable bioengineered human tissue used to treat vascular trauma in the extremities.
- Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
- Arterial injuries resulting from vascular trauma are common in military populations, and in civilians due to motor vehicle, workplace and sporting accidents, gun violence, mass casualty terrorist attacks, stabbings, blunt trauma, and iatrogenic injuries (injuries caused by medical treatment or examination). Currently, autologous vein (harvested from the patient’s body through a separate surgical incision) is the preferred conduit for arterial repair, but is not always feasible due to damage to veins or to the limbs, and requires additional time and resources, delaying the time from injury to restoration of blood flow for the injured patient.
- Symvess is bioengineered human tissue that can be removed from its packaging and be ready for implantation into a vascular trauma patient within minutes.
- Symvess is administered by surgical implantation to replace the injured extremity artery. Symvess may be trimmed to provide the length required for each vascular repair, and can also be cut into different lengths and used to repair more than one injured extremity artery in the same patient.
- FDA approval of Symvess was based on data from a prospective, single arm, multicenter study of 54 patients with life- or limb-threatening vascular trauma. Of the 54 patients evaluated, 36 (67%) retained primary patency (blood flow present without any intervention) and 39 (72%) retained secondary patency (at least one intervention required to maintain blood flow) 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 end of study (month 36).
- Symvess comes with a Boxed Warning for graft failure that can result in life threatening hemorrhage. Warnings and precautions associated with Symvess include graft rupture, anastomotic failure, thrombosis, and transmission of infectious diseases.
- Common adverse reactions (incidence ≥3%) include thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.
Development timeline for Symvess
| Date | Article |
|---|---|
| Dec 19, 2024 | Approval FDA Approves Symvess (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma |
Further information
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