Acellular Tissue Engineered Vessel
FDA Drug Information • Also known as: Symvess
- Brand Names
- Symvess
- Route
- INTRAVASCULAR
- Dosage Form
- IMPLANT
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
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 )
Description
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. Human vascular smooth muscle cells that are derived from human aortic tissue deemed suitable for transplant are banked, expanded, and seeded onto a tubular mesh scaffold. The cell-seeded scaffold is cultured in a biomimetic bioreactor system to generate an intermediate tubular construct containing vascular smooth muscle cells and the extracellular matrix the cells deposited. A final decellularization process removes the human cellular and genetic material while maintaining the extracellular matrix structure and mechanical and biological activity. SYMVESS manufacture includes use of reagents derived from human and animal materials. Human male AB serum and fetal bovine serum (FBS) are used in the manufacturing process for the cultivation and expansion of the vascular smooth muscle cells. SYMVESS is fixed inside the packaging bag between the endcaps with a supporting silicone tube and is immersed in sterile phosphate buffered saline solution.
What Is Acellular Tissue Engineered Vessel Used For?
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 )
Dosage and Administration
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. 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. 2.2 Handling of SYMVESS Supplies: The following supplies are not included in the carton, but may be needed for the handling of SYMVESS: 1) Sterile basin (as needed) – see Step 8 for details 2) Sheath tunneler (as needed) – see Section 2.3 and Step 3 for details SYMVESS is to be handled in an appropriate surgical environment as follows: Step 1: SYMVESS box contains a plastic thermoformed tray with a Tyvek ® lid. Open the box and remove the plastic tray ( Figure 1 ). Figure 1: SYMVESS box and plastic tray Step 2: After removing the tray from the box, check the FreezeAlert temperature indicator ( Figure 2 ) attached to the side of the tray. If a check mark is displayed, SYMVESS has not been exposed to freezing temperatures and can be used. If an “X” is displayed, SYMVESS has been exposed to freezing temperatures and should NOT be used. Figure 2: FreezeAlert Temperature indicator Step 3: Two operators (one sterile operator and one non-sterile operator) are required to remove the sterile packaging bag containing SYMVESS from the plastic tray. Inspect the plastic tray to check for damage which can lead to loss in sterility of the SYMVESS. Do not open the tray for further use if the product is expired or has visible damage. If packaging is intact and within date of acceptable use, the non-sterile operator pulls back the Tyvek ® lid by the corner tab to open the plastic tray containing the sterile packaging bag ( Figure 3a and 3b ). Take careful steps to avoid touching the sterile contents inside the tray ( Figure 3c ). Figure...
Side Effects (Adverse Reactions)
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 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 . Table 1 Adverse Reactions Occurring with a Frequency of ≥3% in Study 1 Adverse Reaction Adverse Reaction Frequency based on up to 3 years follow-up data [median 191 days (range 1-1134 days)] Extremity Patients (%) Extremity patients are with arterial repair in upper or lower limbs (n=54) Vascular graft thrombosis 15 (28%) Pyrexia (fever) 9 (17%) Pain 8 (15%) Anastomotic stenosis 5 (9%) Vascular graft rupture or anastomotic failure 4 (7%) Vascular graft infection 3 (6%) Long term follow-up of up to 36 months in Study 1 is ongoing. At the data cut-off date, 7 out of 54 patients in the extremity group have completed the study (i.e., completed 36 months of follow-up). The safety of SYMVESS beyond 36 months was not evaluated in the clinical studies for this indication.
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.
Pregnancy and Breastfeeding
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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SYMVESS is for single patient use only and is supplied in a sealed sterile packaging bag. The packaging bag is contained within a plastic thermoformed tray sealed with a Tyvek ® lid, the contents of which are sterile. The sealed plastic thermoformed tray (NDC 83564-110-00) is contained within a non-sterile carton (NDC 83564-110-01). SYMVESS is fixed inside the packaging bag between the endcaps with a supporting silicone tube and is immersed in sterile phosphate buffered saline solution. SYMVESS, the saline solution, and the outer surface of the packaging bag are sterile. SYMVESS is shipped in an insulated shipping box (2ºC to 8ºC). 16.2 Storage and Handling Store SYMVESS at 2ºC to 8ºC (36ºF to 46ºF). Use SYMVESS prior to the expiration date printed on the carton. Do not freeze. A FreezeAlert temperature indicator is attached to the exterior of each thermoformed tray that contains a SYMVESS. Prior to preparing SYMVESS for a procedure, check the FreezeAlert indicator. A check mark indicates SYMVESS has not been exposed to freezing temperatures and can be used. An “X” displayed on the indicator signifies that SYMVESS has been exposed to freezing temperatures and should NOT be used [see Handling of SYMVESS (2.2) ] . DO NOT use SYMVESS if: carton has been damaged Tyvek ® lid is punctured or detached thermoformed tray is punctured or compromised there is evidence of fluid leakage from the packaging bag FreezeAlert temperature indicator has an “X” Dispose of unused SYMVESS and packaging bag using established clinical facility procedures in accordance with local regulatory requirements. Contact Customer Care at 1-833-591-0081 for further instructions or questions. 16.1 How Supplied SYMVESS is for single patient use only and is supplied in a sealed sterile packaging bag. The packaging bag is contained within a plastic thermoformed tray sealed with a Tyvek ® lid, the contents of which are sterile. The sealed plastic...
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.