Symvess
This site is intended for U.S. audiences only.

Approved Trauma
Indication

Indication and Usage

Symvess® is the first and only 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.1

Symvess is surgically implanted to repair an injured artery and restore blood flow post implantation.1 Over time, Symvess repopulates with the patient’s cells.1-3

Managing Risk

Vascular trauma injuries threaten life and limb. Repairing an injured vessel may involve surgical reconstruction or bypass procedures. Surgeons may use the patient’s own vein (usually harvested from the thigh), or synthetic/biologic grafts.
Patients with arterial extremity injuries face risks such as infection and amputation. Average costs associated with complications in vascular trauma:4

>$90,000

2 Year Amputation Costs4

>$500,000

Lifetime Cost of Amputations,
which is 3x higher than reconstruction with limb salvage4

45%

of Lower Extremity Amputations,
are due to trauma5

Current repair options  may not be appropriate  for all patients requiring a vascular graft.

Saphenous Vein Grafts
  • 15-30% of patients do not have adequate saphenous vein6
  • Harvesting and preparation add operative time7,8
  • 2-20% of patients develop harvest site complications, including infection9
  • Poor size match10
Synthetic Grafts
  • 20-40% infection rate11,12
  • Up to 28-40% may require revision or explant due to infection13-15
Non-autologous &
Non-synthetic Grafts
  • Minimal peer-reviewed clinical data available16
  • Extra prep time due to thawing and rinsing17-19

Important Characteristics of Non-Autologous Vein Conduits Include20:

Resistance to infection
Available as an off-the-shelf product
Resistance to thrombosis
Durability over the long-term
Mechanical compliance
Regenerative capacity
Non-immunogenic
References:
  1. Symvess U.S. Prescribing Information. Durham, NC. Humacyte Global, Inc.
  2. Kirkton RD, et al. Bioengineered human acellular vessels recellularize and evolve into living blood vessels after human implantation. Sci Transl Med. 2019;11(485):eaau6934.
  3. Dahl S, et al. Readily available tissue-engineered vascular grafts. Sci Transl Med. 2011 Feb 2;3(68):68ra9.
  4. MacKenzie EJ, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007 Aug;89(8):1685-92.
  5. Ziegler‐Graham K, et al. Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050. Archives of Physical Medicine and Rehabilitation. 2008;89(3):422‐9.
  6. Guntani A, et al. Long-Term Results of Femorotibial Polytetrafluoroethylene Bypass with a Distal Vein Cuff for Critical Limb Ischemia. Ann Vasc Dis. 2018 Sep 25; 11(3):306–311.
  7. Zenati, MA, et al. Randomized trial of endoscopic or open vein-graft harvesting for coronary-artery bypass. N Engl J Med 2019;380:132-41.
  8. Wise ES, et al. An Optimized Preparation Technique for Saphenous Vein Graft. Am Surg. 2015 July ; 81(7): E274–E276
  9. Larsson H, et al. Patients’ experiences regarding severe leg wound infection associated with coronary artery bypass grafting: A qualitative study. J Vasc Nurs. 2023 Mar;41(1):12-18.
  10. Data on File.
  11. Watson JD, et al. A retrospective cohort comparison of expanded polytetrafluorethylene to autologous vein for vascular reconstruction in modern combat casualty care. Ann Vasc Surg 2015;29:822-9.
  12. Guerrero A, et al. Limb loss following lower extremity arterial trauma: what can be done proactively? Injury 2002;33:765-9.
  13. Bachleda P, et al. Infected prosthetic dialysis arteriovenous grafts: a single dialysis center study. Surg Infect (larchmt). 2012;13:366e370.
  14. Andercou O, et al. Complex treatment of vascular prostheses infections. Medicine 2018; 97:27(e11350).
  15. Miyake K, et al. Results of Graft Removal and Negative Pressure Wound Therapy in Management of Graft Infection. Int J Angiol. 2019 Mar;28(1):39-43.
  16. Artegraft CryoVein RightFind Resource Center Publication Search 13MAY2024.
  17. Artivion CryoVein Thaw Rinse Instructions L7092.003.pdf
  18. LeMaitre RestoreFLow Receiving Unpacking LMAT Allograft Step A 7086F_VS3.pdf, RestoreFlow Thawing LMAT Allograft Step B 7087F_VS3.pdf, RestoreFlow Prepping LMAT Allograft Step C 7088F_VS4.pdf
  19. LeMaitre Artegraft LS 012 Rev W IFU.pdf
  20. Ravi S, et al. Biomaterials for vascular tissue engineering. Regen Med. 2010 January; 5(1): 107.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR SYMVESS

IMPORTANT SAFETY INFORMATION

BOXED WARNING: GRAFT FAILURE

  • Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

CONTRAINDICATIONS

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.

WARNINGS & PRECAUTIONS

  • Graft Rupture: Vascular graft rupture has occurred in patients treated with SYMVESS. 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.
  • Anastomotic Failure: Anastomotic failure has occurred in patients treated with SYMVESS. 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.
  • Thrombosis: Thrombosis has occurred in patients treated with SYMVESS. In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS.
  • Transmission of Infectious Diseases: SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of SYMVESS are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases. Animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, but this does not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. No transmissible agent infections have been reported during clinical testing.

ADVERSE REACTIONS

The most common adverse reactions (≥3%) were thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of SYMVESS in pediatric patients (0 to 17 years old) have not been established.

Geriatric Use: Two 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.

INDICATION

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.

Full U.S. Prescribing
Information
INDICATION AND IMPORTANT SAFETY INFORMATION FOR SYMVESS

IMPORTANT SAFETY INFORMATION

BOXED WARNING: GRAFT FAILURE

  • Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage.

CONTRAINDICATIONS

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.

WARNINGS & PRECAUTIONS

  • Graft Rupture: Vascular graft rupture has occurred in patients treated with SYMVESS. 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.
  • Anastomotic Failure: Anastomotic failure has occurred in patients treated with SYMVESS. 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.
  • Thrombosis: Thrombosis has occurred in patients treated with SYMVESS. In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS.
  • Transmission of Infectious Diseases: SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of SYMVESS are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases. Animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, but this does not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. No transmissible agent infections have been reported during clinical testing.

ADVERSE REACTIONS

The most common adverse reactions (≥3%) were thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of SYMVESS in pediatric patients (0 to 17 years old) have not been established.

Geriatric Use: Two 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.

INDICATION

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.

Full U.S. Prescribing
Information