What is Vergenix™FG?
Vergenix™ Flowable Gel (Vergenix™FG) is an advanced wound care device composed of recombinant human type I collagen (rhCollagen) produced from bioengineered tobacco plants and hydroxypropyl methyl cellulose. The device is indicated for the management of chronic and acute wounds. Vergenix™FG is intended for a one-time application only.
How is the product supplied?
The device is supplied in a dry form inside a syringe as part as a single use kit that contains one filled syringe, one empty syringe, one luer-lock connector and one cannula. When hydrated with saline the device forms a whitish gel.
How does Vergenix™FG work?
Vergenix™FG is a bio-degradable device that provides a scaffold for cellular proliferation and capillary growth. The collagen scaffold, through integrin and fibronectin binding sites, attracts fibroblasts and immune cells to the wound site to form a new granulation tissue. The granulation tissue contracts and reduces the wound size as well as enables keratinocytes to migrate and reepithelialize, leading to final wound closure.
Which types of wounds can be treated with Vergenix™FG?
Vergenix™FG is indicated for the management of chronic and acute wounds including:
• Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Second degree burns
• Donor sites and other surface bleeding wounds
• Trauma wounds healing by secondary intention
• Surgical wounds
• Deep and tunneled/undermined wounds
What is the product shelf life?
How should it be stored?
The product should be stored at room temperature (5°C – 30°C).
Product Preparation and application
Product Preparation and application
Who can apply the product?
Vergenix™FG can only be applied by a healthcare professional i.e. nurse or physician
I am a healthcare professional, how do I prepare the product?
Please refer to the product IFU for preparation instructions.
What is the recommended procedure for wound bed preparation before product application?
Debridement or excision may be performed prior to gel application to remove any remaining necrotic tissue that may cause infection.
In which cases the product should not be used?
Vergenix™FG should not be applied until excessive exudate, bleeding, acute swelling and infection are controlled. Vergenix™FG should not be used in patients with known sensitivity to collagen. Vergenix™FG is not indicated for wound with active vasculitis, third degree burns, ulcerating neoplasm or ulcerating chronic skin disease (necrobiosis lipoidica, pyoderma gangrenosum).
What are the next steps after product application?
The product is intended for a one-time application. Following a single application, a secondary dressing should be used to maintain the gel adherence and protect the wound area. The optimum dressing is determined by wound location, size, depth and user preference. The secondary dressing should be changed as needed to manage exudate. Frequency of dressing changes will be dependent upon volume of exudate produced, type of secondary dressing used and the clinician’s need to inspect the wound bed for signs of infection or healing.
Can the product be re-used?
No, the product should not be reused. Reuse of product will cause loss of sterility. The product should not be re-sterilized.
Where is Vergenix™FG appvored?
Vergenix™FG is CE marked and approved for sales in Europe and Israel.
How can I get Vergenix™FG?
For more information on product availability in your country, please contact firstname.lastname@example.org