Symvess ACELLULAR TISSUE ENGINEERED VESSEL 420 mm Implant, 1 implant
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII D9FS8LTC4V
A sterile salt solution that mimics the body's natural fluids, used as a vehicle or diluent to dissolve or suspend the active ingredient. It helps maintain proper pH and osmotic balance in liquid formulations.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Symvess 420 mmthis 83564-0110-00 | Humacyte | 1 implant | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 19, 2036 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83564-0110-00 You're viewing this | 1 BOX in 1 BAG (83564-110-00) / 1 IMPLANT in 1 BOX (83564-110-01) | 2024-12-19 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed 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 )
🎯 Indications and Usage ▾
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 )
2.1Dosage 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.
2.2Handling 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 3a: Non-sterile operator pulls back the Tyvek ® lid by the corner tab Figure 3b: Non-sterile operator opens the plastic tray containing the sterile packaging bag Figure 3c displays the components of SYMVESS within the plastic tray. Figure 3c: SYMVESS with each component Step 4: The non-sterile operator holds the bottom of the plastic tray with one hand and opens the Tyvek ® lid with the other.
The sterile operator removes the sterile packaging bag from the tray by grasping the ports (i.e., tubing) at the ends of the sterile packaging bag to remove the sterile packaging bag from the tray ( Figure 4 ). Place the sterile packaging bag on a sterile surface. Figure 4: Sterile operator (grey gown and gloves; left) removes the packaging bag from plastic tray by grasping the ports (tubing) while non-sterile operator (white gloves; right) holds the plastic tray and opens the Tyvek ® lid Step 5 : SYMVESS is suspended in sterile saline inside the packaging.
The sterile operator cuts one or both o…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS SYMVESS is an acellular tissue engineered vessel composed of organized extracellular matrix (ECM) proteins. SYMVESS is implanted using standard surgical techniques as a vascular construct to replace a patient’s damaged extremity artery after injury. SYMVESS has dimensions of 6 mm in inner diameter and 42 cm in length (approximately 40 cm of usable length).
Since the length of SYMVESS to be implanted is dependent on the surgical needs, it is cut to length by the surgeon in the operating room [see Administration (2.3 steps 5 and 6) ] . SYMVESS is an acellular tissue engineered vessel composed of organized extracellular matrix (ECM) proteins. It has dimensions of 6 mm in inner diameter and 42 cm in length (approximately 40 cm of usable length).
( 3 )
⛔ 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.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Graft Rupture. ( 5.1 ) Anastomotic Failure. ( 5.2 ) Thrombosis. ( 5.3 ) Transmission of Infectious Diseases ( 5.4 )
5.1Graft 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) ] .
5.2Anastomotic 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) ] .
5.3Thrombosis 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 risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS.
5.4Transmission 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 which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis ( Treponema pallidum) .
The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease.
No transmissible agent infections have been reported during clinical testing.
🤒 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 .
6.1Clinical 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric Use The safety and effectiveness of SYMVESS in pediatric patients (0 to 17 years old) have not been established.
8.5Geriatric 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.
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SYMVESS in pediatric patients (0 to 17 years old) have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics The pharmacodynamic effects of SYMVESS are not known.
12.3Pharmacokinetics The pharmacokinetic effects of SYMVESS are not known.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
12.2Pharmacodynamics The pharmacodynamic effects of SYMVESS are not known.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How 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).
16.2Storage 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.
16.1How 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).
📦 Storage and Handling ▾
16.2Storage 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.
📋 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Counsel the patient on the following: Graft Rupture Inform patients that bleeding can occur from the graft site and that subsequent intervention, explant, or additional procedures may be required after initial repair. Advise patients to seek urgent medical evaluation if they develop any bleeding from the surgical site, or have any signs or symptoms that would indicate failure of the graft such as worsening pain, loss of limb function or change in color of overlying skin. [see Warnings and Precautions (5.1) ].
Anastomotic Failure Inform patients that in certain situations, bleeding can occur at the graft anastomosis site and that subsequent intervention, explant, or additional procedures may be required to repair this. 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. [see Warnings and Precautions (5.2) ]. Thrombosis Inform patients that in certain situations, thrombosis can occur after SYMVESS implantation.
At the surgeon's discretion, consider use of antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of thrombosis including worsening pain at the surgical site, swelling, changes of color of the overlying skin, or warm skin around the painful area. [see Warnings and Precautions (5.3) ].
Transmission of Infectious Diseases Inform patients of the possible risk of transmission of infectious diseases with SYMVESS. [see Warnings and Precautions (5.4) ]. Manufactured by: Humacyte Global, Inc. 2525 E.
NC Highway 54 Durham, NC 27713 USA SYMVESS ™ is a trademark of Humacyte Global, Inc.