symvess (acellular tissue engineered vessel-tyod) · Humacyte Global Inc.
SYMVESS is an acellular tissue engineered vessel 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.
Details
- Status
- Prescription
- First Approved
- 2024-12-18
- Patent Cliff
- 2036
- Routes
- Implantation
- Dosage Forms
- Implant
symvess Approval History
What symvess Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2024)
symvess Boxed Warning
GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. [See Warnings and Precautions (5.1 , 5.2) ] WARNING: GRAFT FAILURE See full prescribing information for complete boxed warning. Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. ( 5.1 , 5.2 )...
WARNING: GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. [See Warnings and Precautions (5.1 , 5.2) ] WARNING: GRAFT FAILURE See full prescribing information for complete boxed warning. Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. ( 5.1 , 5.2 )
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
symvess FDA Label Details
Indications & Usage
SYMVESS™ is an acellular tissue engineered vessel 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. SYMVESS™ is an acellular tissue engineered vessel 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.
WARNING: GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. [See Warnings and Precautions (5.1 , 5.2) ] WARNING: GRAFT FAILURE See full prescribing information for complete boxed warning. Loss of SYMVESS integrity due to...
Track symvess with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.