Vet BioSISt

Manufacturer: Global Vet Products

Tissue Repair Sheet

Composition

VET BIOSIST™ tissue repair sheets are composed of a biocompatible matrix. The single layered lyophilized sheets are not synthetic, but are a naturally-occurring derivative of the submucosal layer of the porcine small intestine which has been disinfected to remove bacterial and viral components. This “natural” material contains collagen (Types I, III and V), fibronectin, decorin, hyaluronic acid, chondroitin sulphate A, heparan sulphate, and growth factors (TGFβ, FGF-2, and VEGF).

Vet BioSISt Indications

VET BIOSIST™ is for use as a surgical patch for soft tissue repair or reinforcement. It promotes wound healing and tissue remodeling by providing a biocompatible, absorbable scaffold for tissue ingrowth. It is suitable for dermal tissue repair applications where the skin cannot be sutured together or when subdermal tissues are damaged. Other potential applications of this surgical patch include repairs of internal organs, cleft palate, periodontal tissue, and corneal ulcers. VET BIOSIST™ has also been used in surgery as an anti-adhesion barrier, a suture reinforcement sheet, and a hemostatic plug.

Vet BioSISt Dosage And Administration

Suggested Instructions for Use: Always handle VET BIOSIST™ using sterile technique. Prepare wound area using standard methods to insure wound is free of debris and necrotic tissue. Debride the wound to insure the wound edges contain viable tissue. When necessary, it is recommended that VET BIOSIST™ is not applied until excessive exudate, bleeding, acute swelling and infection are controlled.

To apply, cut the dry sheet with sterile scissors into a patch slightly larger than the outline of the wound area. Rehydrate the patch by placing it in a bowl of sterile saline or other isotonic solution for at least one (1) minute before placing the patch over the wound surface. In dermal applications, place the edge of the patch under the edge of the intact tissue to encourage tissue overgrowth during wound healing. Secure the patch to the wound edges using sutures or small surgical clips.

In large area wounds, multiple sheets may need to be used and several evenly spaced sutures may be placed through the patch and into the wound bed to enhance overall contact between the tissue and the patch. If excess exudate collects under the patch, small openings can be cut in the patch to allow the exudate to drain.

Use an appropriate dressing to maintain a moist wound environment. The optimum dressing is determined by wound location, size, depth, and surgeon preference. For external wounds, it is recommended that the VET BIOSIST™ patch be covered with an aqueous gel and a non-adhesive dressing. Cover this dressing with a dry exterior dressing that will protect the wound and maintain internal moisture. Leave the moist interior dressing undisturbed for at least three (3) days or until the VET BIOSIST™ patch begins to be absorbed into the underlying tissue. The VET BIOSIST™ patch should not be removed.

Vet BioSISt Caution(s)

VET BIOSIST™ is not for use in humans or in vitro diagnostics.

Initial application of this product may produce mild, localized inflammation. If this condition worsens or persists beyond five (5) days. the product should be removed. If noticeable wound infection occurs, appropriate oral antibiotic therapy should be administered. If infection persists, the product should be removed and the wound should be surgically debrided. When used in high pressure applications, sheets may need to be placed in multiple layers to provide adequate strength. This product is derived from a porcine source. Animals with known sensitivity to porcine material should not be exposed to this product.

Storage

VET BIOSIST™ sheets are stable for 12 months when kept dry and stored in the original, unopened packaging at room temperature.

Sterility: Supplied sterile in easy open packages, for one-time use. Re-sterilization of this product will result in product degradation.

Distributed By

Butler and Provet.

V-BSRS1099

Presentation

Available:

Multilaminate Sheet: Multilaminate sheets are packaged in double peel-pouches. The surface characteristics of both sides of the multilaminate sheet are the same. Each single layer sheet is available as 70 mm x 100 mm or (2) 70 mm x 200 mm and a multilayer sheet 70 mm x 100 mm is used for internal hernia repairs. Twin pack 70 x 40 mm, 2 sealed sheets per pack Supplied sterile in easy open packages, for one time use.

Ocular Disc: Ocular discs are packaged in double peel-pouches with the rough side indicated by a notch. Experiments have shown that cell ingrowth increases if the rough side is placed against the wound. Each disc is 10 mm or 15 mm in diameter. Four individual discs are supplied sterile in sealed sections of easy open packages, for one time use.

Nac No.

12850002