Gore-Tex Bio-A Fistula Plug
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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.
Description
GORE® BIO-A® Fistula Plug
For the repair of anorectal fistulas, fistula plugs can often be used as a successful alternative to fistulotomy, fistulectomy, and other invasive procedures. Fistula repairs using a plug avoid dividing the sphincter muscles, thereby reducing the risk of incontinence. The fistula plug provides a scaffold for soft tissue repair and facilitates closure of the fistula. However, failures can occur due to dislodgment of the plug from the fistula tract.
Product Code: FP0616
- Six 9cm Tubes
- 16mm Disk
GORE® BIO-A® Fistula Plug helps surgeons to optimize the operative success of sphincter-preserving anal fistula repair. Its patented design enables robust device placement; the plug is engineered to conform to the fistula tract—reducing the potential for failure due to fall-out. A single plug configuration is tailorable to fit most fistula shapes and sizes.
The GORE® BIO-A® Fistula Plug incorporates a proven, 100% synthetic bioabsorbable scaffold facilitating tissue generation and healing. PGA:TMC fibers form a non-woven web with open, highly interconnected pores. Cells migrate into the scaffold and tissue is generated as the body gradually absorbs the material, leaving no permanent material in the body.
Additional information
| Size | 1 |
|---|---|
| Arms | N/A |
| Manufacturer | |
| Unit | box of 1 |
- FDA Product Code: FTL
- FDA Product Code Name: Mesh, surgical, polymeric
- GMDN Term Code: 44688
- GMDN Term Name: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- GMDN Term Description: An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.
