Acellular Tissue Engineered Vessel

SYMVESS is an acellular tissue engineered vessel composed of human extracellular matrix (ECM) that exhibits mechanical and biological activity. Product testing results have shown that SYMVESS can withstand the forces associated with the arterial blood flow and suturing during implantation.

• 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.

• DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.contraindicated

For surgical vascular implantation only. SYMVESS is administered by surgical implantation to replace the injured extremity artery. The anatomical location and length are decided upon at the discretion of the implanting surgeon and based on the appropriate preoperative clinical evaluation, vessel mapping and/or imaging. ( 2.1 ) SYMVESS may be trimmed to provide the length required for each vascular repair. Additionally, a single SYMVESS can be cut into different lengths and used to repair more than one injured extremity artery in the same patient. Each SYMVESS unit is for administration to a single patient only. ( 2.1 ) 2.1 Dosage SYMVESS is administered by surgical implantation to replace the injured extremity artery. The anatomical location in the extremity and length required should be determined by the surgeon implanting the graft based on the appropriate pre-operative clinical evaluation, vessel mapping and/or imaging, and intra-operative considerations. SYMVESS is provided as follows: 6 mm in internal diameter and 42 cm in length. Once removed from packaging, its usable length is approximately 40 cm. Each package (i.e., box containing Tyvek ® -sealed tray) contains one SYMVESS unit for administration to a single patient only. SYMVESS may be trimmed to provide the length required for the artery replacement. SYMVESS can be trimmed to replace more than one injured extremity artery in the same patient.

Graft Rupture. ( 5.1 ) Anastomotic Failure. ( 5.2 ) Thrombosis. ( 5.3 ) Transmission of Infectious Diseases ( 5.4 ) 5.1 Graft Rupture Vascular graft rupture has occurred in patients treated with SYMVESS [see Clinical Trials Experience (6.1) ] . Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Follow appropriate procedures for handling and administering SYMVESS [see Dosage and Administration (2) ] . 5.2 Anastomotic Failure Anastomotic failure has occurred in patients treated with SYMVESS [see Clinical Trials Experience (6.1) ] . In clinical studies of SYMVESS, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Follow appropriate procedures for handling and administering SYMVESS [see Dosage and Administration (2) ] . 5.3 Thrombosis Thrombosis has occurred in patients treated with SYMVESS [see Clinical Trials Experience (6.1) ] . In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis.

The most common adverse reactions (incidence ≥3%) were thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Humacyte Global, Inc. at 1-833-591-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to adverse reaction rates in clinical trials of other products, and they may not reflect the rates observed in real-world clinical practice. The safety data described in this section reflect exposure to SYMVESS in one single arm, open-label study in patients requiring vascular replacement or reconstruction for life or limb threatening vascular trauma, Study 1 (CLN-PRO-V005; NCT03005418). A total of 54 adults received extremity implantation of SYMVESS as a vascular conduit. The patient population ranged in age from 18 to 72 years (mean age 33 years). Each patient received a SYMVESS implant ranging in length from 1 to 35 cm (mean length 10.1 cm). The most frequently occurring adverse reactions are shown in Table 1 .

8.1 Pregnancy Risk Summary The limited clinical data that are available with SYMVESS use in pregnant women are insufficient to inform a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with SYMVESS to assess whether it can cause harm to the mother or fetus when administered to a pregnant woman. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the transmission of antibodies or any components of SYMVESS in human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SYMVESS and any potential adverse effects on the breastfed infant from SYMVESS or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of SYMVESS in pediatric patients (0 to 17 years old) have not been established. 8.5 Geriatric Use Two (2) patients out of the 54 Extremity Group implanted with SYMVESS as a conduit in Study 1 were aged ≥65 years. The number of patients aged ≥65 years was not sufficient to determine whether they responded differently than younger patients to SYMVESS.

Metabolism

The pharmacokinetic effects of SYMVESS are not known.

1. 1Failure To Anastomose450%
2. 2Vascular Graft Complication338%
3. 3Post Procedural Haematoma225%
4. 4Anastomotic Haemorrhage113%
5. 5Groin Infection113%
6. 6Haemorrhage113%
7. 7Infection113%
8. 8Off Label Use113%
9. 9Stenosis113%
10. 10Vascular Graft Occlusion113%
11. 11Vascular Graft Thrombosis113%

Recent PubMed references pinned to Acellular Tissue Engineered Vessel as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Preclinical testing of acellular and polyphenol-stabilized arterial xenografts in sheep.
  The journal of vascular access · 2026 · Harpa MM, Anitei ED, Simionescu DT, et al.
  PMID 41063433DOI 10.1177/11297298251382538
• Cilostazol-loaded acellular vascular graft for suppressing intimal hyperplasia.
  Biomaterials advances · 2025 · Mahara A, Shimizu K, Le HT, et al.
  PMID 40737889DOI 10.1016/j.bioadv.2025.214433
• Vascular microphysiological systems (MPS): biologically relevant and potent models.
  Lab on a chip · 2025 · Breuil L, Kitada A, Yadav S, et al.
  PMID 40613759DOI 10.1039/d5lc00014a
• The Decellularization and Crosslinking Efficacy of Perfusion Bioreactors in Small-Diameter Porcine Carotid Artery Grafts.
  Artificial organs · 2025 · Nguyen NT, Vu BD, Huynh TD, et al.
  PMID 40488333DOI 10.1111/aor.15037
• Native and decellularized porcine vena cava: Biomechanical and microstructural comparison.
  Acta biomaterialia · 2025 · Massaro MS, Sommer G, Pukaluk A, et al.
  PMID 40456303DOI 10.1016/j.actbio.2025.05.071
• In-Situ Vascular Regeneration by Host Cells of Acellular Human Saphenous Vein Implanted in Porcine Carotid Artery.
  International journal of molecular sciences · 2025 · Bond A, Bruno V, Sulaiman N, et al.
  PMID 40429860DOI 10.3390/ijms26104718
• Enhancing small diameter tissue engineered vascular grafts with heparin and hepatocyte growth factor: A promising approach.
  The International journal of artificial organs · 2024 · Cai Z, Tan Z, Tian R, et al.
  PMID 39620968DOI 10.1177/03913988241293011
• Stochastic to Deterministic: A Straightforward Approach to Create Serially Perfusable Multiscale Capillary Beds.
  ACS biomaterials science & engineering · 2025 · Donzanti MJ, Ferrick BJ, Mhatre O, et al.
  PMID 39606830DOI 10.1021/acsbiomaterials.4c01247

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Acellular Tissue Engineered Vessel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass
  Enrolling by invitation · Interventional · 20 enrolled · Vascudyne, Inc.
  NCT07078370updated 2025-12-02
• Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
  Completed · Phase 3 · Interventional · 242 enrolled · Humacyte, Inc.
  NCT03183245updated 2025-11-20
• Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular Disease and Dialysis Access
  Temporarily not available · Expanded access · Humacyte, Inc.
  NCT07141641updated 2025-09-15
• Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries
  Approved for marketing · Expanded access · Humacyte, Inc.
  NCT03631056updated 2025-08-24
• Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
  Completed · Phase 3 · Interventional · 355 enrolled · Humacyte, Inc.
  NCT02644941updated 2025-03-30
• To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
  Recruiting · Phase 3 · Interventional · 150 enrolled · Humacyte, Inc.
  NCT05908084updated 2025-03-18
• Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
  Completed · Interventional · 40 enrolled · Humacyte, Inc.
  NCT01744418updated 2024-11-13
• Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD
  Completed · Interventional · 20 enrolled · Humacyte, Inc.
  NCT01872208updated 2024-11-13
• Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
  Completed · Phase 2 · Interventional · 30 enrolled · Humacyte, Inc.
  NCT04135417updated 2024-03-19
• Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
  Completed · Phase 1 · Interventional · 20 enrolled · Humacyte, Inc.
  NCT01840956updated 2022-08-19

Frequently asked questions

How does Acellular Tissue Engineered Vessel work?

SYMVESS is an acellular tissue engineered vessel composed of human extracellular matrix (ECM) that exhibits mechanical and biological activity. Product testing results have shown that SYMVESS can withstand the forces associated with the arterial blood flow and suturing during implantation.

What is Acellular Tissue Engineered Vessel used for?

According to FDA labeling, Acellular Tissue Engineered Vessel carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Acellular Tissue Engineered Vessel?

Acellular Tissue Engineered Vessel is marketed under brand names including Symvess.

What are the contraindications for Acellular Tissue Engineered Vessel?

Acellular Tissue Engineered Vessel labeling lists contraindications including: DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries.. Always consult the full prescribing information and a clinician.