Features and Benefits

The Symvess Difference

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Introducing

Symvess®
acellular tissue engineered vessel-tyod

The first and only human-derived acellular vessel for vascular trauma repair.¹ Precisely bioengineered for consistency and predictability from vessel to vessel.^2,3

Designed to address challenges and limitations in vascular repair, Symvess retains bioactivity, restores blood flow post-implantation, and repopulates with the patient’s cells.^1-3

6mm diameter x
40cm usable-length¹

Off-the-shelf,
ready to use^1,2

Symvess is available for use off-the-shelf, and ready to use straight out of the package without the need for significant preparation such as rinsing or thawing.^1,2

Symvess eliminates the need for vein harvesting, which helps reduce ischemia time.^1,2

No immune
response
observed^1-3,5

Symvess begins from donated human aortic smooth muscle cells.^1-3 After the vessel is formed the cell nuclei are removed and 20+ Key extracellular matrix proteins are retained, leaving an intact bioactive, extracellular matrix (ECM) that is universally implantable with no observed rejection in clinical studies.^1-5

Low
susceptibility
to infection⁶

In vitro study demonstrated that Symvess exhibited low susceptibility to infection, likely due to its biocompatibility with host cells including neutrophils because of its native-like composition of human extracellular matrix proteins.⁶ This is especially important with extremity arterial trauma injuries which carry a high risk of infection due to their inherently contaminated nature.⁷

Strength
similar to
femoral artery^2,3

In studies, the strength of Symvess matched that of femoral artery, which is stronger than saphenous vein, the current standard of care in vascular trauma repair.^2,3

Symvess possesses the mechanical properties capable of withstanding surgical manipulation and averting mechanical failure post-implantation. The extracellular matrix (ECM) is composed of cross-linked vascular collagens type I and III, known for their tensile strength.⁸

The structural and mechanical attributes, including wall thickness, suture strength, and burst pressure of Symvess are similar to those of femoral artery.^2,3

Repopulates
with the
patient’s cells^1-3

Symvess retains bioactivity.^1-3 Once implanted, Symvess restores blood flow.^1-3 The bioactive properties of Symvess harness the body’s own natural processes, and over time, Symvess repopulates with the patient’s cells.^1-3

How It Works

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