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VersaWrap - Absorbable Implant Device
VersaWrap is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue, and is intended to manage peripheral nerve injuries where there is no significant loss of nerve tissue. The device may also be used to manage and protect surrounding tissues such as ligament and skeletal muscle. VersaWrap was designed to separate healing tissue from surrounding tissues to protect tissue gliding, intrinsic healing, and the neural environment. VersaWrap can be placed under, over, or around injured tissues where there is potential for unwanted postoperative tethering. VersaWrap remains in place until healing is complete and then is bioresorbed. VersaWrap is designed to handle the demands of soft tissue protection.
VersaWrap is cleared for use in procedures where there is no significant loss of tendon and/or peripheral nerve tissue. Examples of such procedures include:
- crush injuries
- stretch injuries
- compression injuries
- primary repair of tendon, ligament, skeletal muscle, or peripheral nerve
- tenolysis / neurolysis
- decompression procedures
- completely or partially severed tendon / peripheral nerve
- Extremity procedures where there is potential for tissue attachments
- over direct suture repair
- reattachment or lengthening
- transposition
- nerve transfer / neuroplasty
VersaWrap includes a bioresorbable, plant-based (non-tissue, non-animal, non-cell, non-collagen) hydrogel sheet and a wetting solution. The sheet is transparent, flexible, ultrathin, non-sided, and can be cut to the desired size. The sheet can be implanted wet or dry and does not stick to tissues, allowing for easy positioning on or around target tissues. Once positioned, the solution is added to the sheet surface, relaxing the sheet onto underlying tissues and causing conformability and tissue adherence. This adherence precludes the need for sutures or tissue glue.
VersaWrap is made of polysaccharides alginate and hyaluronic acid, and contains no animal derived components.
The VersaWrap sheet is an ultrathin plant-based hydrogel consisting of biopolymers hyaluronic acid and alginate
The VersaWrap solution is a non-toxic wetting solution that relaxes the sheet onto underlying tissues and surfaces
- Cut VersaWrap sheet to size
- Sheet may be implanted dry, as packaged, or dipped in water or saline
- Paper backing provided with sheet may be used to support delivery
- Application in confined spaces may require lifting the target tissues
- Wrap sheet to ensure complete coverage of injured and exposed tissues
- Minimally overlap, if needed
- Ensure sheet is touching target tissues
- Secure sheet with VersaWrap solution; No sutures or tissue glue are needed
- VersaWrap remains in place to maintain separation and gliding; VersaWrap bioresorbs seamlessly alongside healing, allowing tissues to return to their pre-injured state