Frequently Asked Questions
What is VETIGEL® made of?
VETIGEL® is a flowable hemostatic gel comprised of algae- and fungi-derived biopolymers. Its components are sodium alginate, poly (N-acetyl-D-glucosamine, D-glucosamine) and water.
How does VETIGEL® work?
VETIGEL® acts as a hemostatic wound covering and plug to stop bleeding. Once gel is applied to a wound, it maintains local pressure and adhesion to aid in the quickening of clot formation via tamponade action. Gel that comes directly in contact with blood crosslinks and forms a strong barrier that maintains durable and long-term hemostasis at the wound site.
How is VETIGEL® applied?
VETIGEL® is applied by following four steps:
- Prime the syringe
- Use gauze to remove excess blood from the field
- Perpendicularly administer gel, directly to the wound
- Shear the gel against the tissue while pulling the syringe away from the wound
How long does it take for VETIGEL® to degrade in the body?
VETIGEL® is a plant-based biopolymer solution made of sodium alginate, poly (N-acetyl-D- glucosamine, D-glucosamine) and water. Given VETIGEL® is a hydrogel mainly comprised of
water, the significant majority (>80%) of the product is absorbed within weeks. The residual poly (N-acetyl-D-glucosamine, D-glucosamine) is expected to degrade in the body enzymatically, and alginates traditionally degrade via acid hydrolysis and/or dissolving due to ion exchange. VETIGEL® has been subjected to human-grade ISO 10993 biocompatibility testing, including long-term implantation studies that have shown the material does not present long-term risk to the patient.
Is VETIGEL® sterile?
Yes. VETIGEL® is terminally sterilized via gamma irradiation.
Are VETIGEL® Dental Accessories sterile?
VETIGEL® Dental Accessories are not claimed to be sterile. VETIGEL® Dental Accessories are cleaned and disinfected via steam autoclave.
Does VETIGEL® pose any biocompatibility risk or risk of rejection by the body?
VETIGEL® was assessed for its biocompatibility per ISO 10993 (human medical device biocompatibility standards) that was interpreted for veterinary use. This testing included cytotoxicity, intracutaneous reactivity, maximization sensitization, pyrogenicity, genotoxicity, and more. The results of the testing confirmed that VETIGEL® is biocompatible and give assurance that VETIGEL® does not pose risk of rejection by the body.
Does the use of VETIGEL® present the risk of adhesion formation?
VETIGEL® is comprised of sodium alginate dissolved in water with solid particles of poly (N- acetyl-D-glucosamine, D-glucosamine) dispersed in it. In two limited studies, use of VETIGEL® was not shown to result in a clinically significant increase in adhesion formation as compared to existing standards of care. While granular materials may be known to increase risk of adhesions, alginates are known to have well-established anti-adhesion properties.
Is VETIGEL® effective in thrombocytopenic or coagulopathic patients?
VETIGEL®’s primary mechanism of action is mechanical (i.e. tamponade) and occurs independently of the patient’s clotting process. VETIGEL® has not been evaluated in coagulopathic patients. Removal of VETIGEL® from a treatment site in patients with coagulopathy may result in rebleeding due to the lack of a durable clot.
Can VETIGEL® be applied topically?
Yes, VETIGEL® can be applied topically.
Can VETIGEL® be used in neurological procedures?
The use of VETIGEL® is being investigated in procedures outside of dental/oral surgery, enucleations, biopsies, and other surgical use cases. VETIGEL® has not been evaluated in neurological procedures, and though there is no indication that it poses significant short-term risk post-application, the long-term risks are currently unknown. Long-term exposure of neurological tissue to granular particles may cause risk.
Can VETIGEL® be used in epistaxis procedures and/or intranasally?
The use of VETIGEL® is being investigated in procedures outside of dental/oral surgery, enucleations, biopsies, and other surgical use cases. VETIGEL® has not been evaluated in epistaxis procedures, though there is no indication that it poses short-term risk post-application.
Is there any risk of embolization when using VETIGEL®?
VETIGEL®’s gel form lends itself to easily flowability and conformance to complex wound geometries. Due to its ionic crosslinking nature in the presence of blood, VETIGEL® has been observed forming a plasticized, strong matrix at the bleeding sites, which may reduce or eliminate the risk of fragmentation. This functionality was designed into the product to improve upon many existing standards of care (sponges, powders) that may present this risk. The risk of an embolic event after administering VETIGEL® has not been formally evaluated in a clinical setting.
Does the use of VETIGEL® increase the risk of post-operative infection?
Sodium alginate is a widely used biopolymer in wound dressings intended to keep wounds moist and to promote wound healing. Poly (N-acetyl-D-glucosamine, D-glucosamine) is often used as an antimicrobial agent in medical devices. These materials have been used in ISO 10993 biocompatibility studies and in clinical scenarios where there have been no reports of increased infection.
The risk of increased infection after administering VETIGEL® has not been formally evaluated in a clinical setting. Use standard of care practices when applying VETIGEL® in contaminated areas.
Does VETIGEL® interact with other drugs?
VETIGEL® has no known or expected interactions with drugs.
Is VETIGEL® safe if ingested?
Yes, VETIGEL®’s constituent polymers are safe for ingestion. However, this is not recommended.
What are VETIGEL®’s contraindications?
- The safety and effectiveness of VETIGEL® for use in ophthalmic procedures have not been established.
- VETIGEL® is not intended to be used for controlling menorrhagia.
- VETIGEL® is not intended to be used as a wound-closure device.
- Do not use VETIGEL® in Equus due to pyrogen sensitivity.
- Do not inject VETIGEL® intravascularly due to risk of embolization.
- Do not close the mucosa over VETIGEL® (in dental)
How should VETIGEL® be stored and what is its shelf life?
Store VETIGEL® in a refrigerator (2-8*C) upon receipt. VETIGEL® has a shelf life of 15 months upon storage. See Instructions For Use for further information.
What are some popular procedures where VETIGEL can be used?
VETIGEL® can be used on a variety of procedures, including but not limited to:
Dental extractions, oral mass removals, abdominal and thoracic mass removals, soft organ biopsies, enucleations, spays & neuters, amputations, venous & arterial bleeds, cholecystectomies, catheterization, lacerations, and ear & tail docking.