Symvess 420 mm/1
ACELLULAR TISSUE ENGINEERED VESSEL · IMPLANT · Humacyte Global, Inc.
Symvess is a implant containing acellular tissue engineered vessel at 420 mm/1, taken intravascular. Manufactured by Humacyte Global, Inc..
Key Facts
- Brand Name
- Symvess
- Generic Name
- ACELLULAR TISSUE ENGINEERED VESSEL
- NDC Code (Product)
83564-110- Manufacturer
- Humacyte Global, Inc.
- Strength
- 420 mm/1
- Dosage Form
- IMPLANT
- Route
- INTRAVASCULAR
- Marketing Status
- Application #
- BLA125812
- Marketing Start
- 12/19/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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 & 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 ® -seale…
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.
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 adve…
Frequently Asked Questions
What is Symvess used for?
Symvess contains ACELLULAR TISSUE ENGINEERED VESSEL. It is a implant taken intravascular. Consult your doctor for specific uses.
Is Symvess a controlled substance?
Symvess is not classified as a controlled substance by the DEA.
What is the generic name for Symvess?
The generic name for Symvess is ACELLULAR TISSUE ENGINEERED VESSEL. There are no other listed brand versions of ACELLULAR TISSUE ENGINEERED VESSEL.
What is the NDC code for Symvess 420 mm/1?
The NDC (National Drug Code) for Symvess 420 mm/1 is 83564-110, listed by Humacyte Global, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)