Overview
11 DESCRIPTION SYMVESS is a sterile, acellular tissue engineered vessel composed of human extracellular matrix (ECM) proteins typically found in human blood vessels. SYMVESS is 6 mm in internal diameter and 42 cm in length (approximately 40 cm of usable length). SYMVESS is manufactured using a tissue engineering process.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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. Product testing results have also demonstrated that SYMVESS ECM can support cell binding and proliferation. However, the exact mechanism of action has not been established. 12.2 Pharmacodynamics The pharmacodynamic effects of SYMVESS are not known. 12.3 Pharmacokinetics The pharmacokinetic effects of SYMVESS are not known.
Indications
- 1 INDICATIONS AND 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. ( 1 )
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Black Box Warning
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 )
Contraindications
- 4 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. 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.
Side Effects
- 6 ADVERSE REACTIONS 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...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.