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Gore Bio-A Fistula Plug
Summary: The Gore Bio-A Fistula Plug is a synthetic device used for treating complex anal and rectovaginal fistulas. It is primarily used in sphincter-sparing procedures. Key evidence suggests variable efficacy in fistula closure.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K083266 ↗
Decision Date ?
March 27, 2009
Product Code ?
FTL
Device Class ?
Class 2
Evidence ?
0 studies
The Gore Bio-A Fistula Plug was cleared via the FDA 510(k) pathway on March 27, 2009. It is manufactured by W.L. Gore & Associates and classified as a Class 2 device.
What It Is
The Gore Bio-A Fistula Plug is a synthetic, bioabsorbable device designed to occlude fistula tracts. It is intended for use in the treatment of complex anal and rectovaginal fistulas, providing a scaffold for tissue regeneration.
FDA-Cleared Indications
- Treatment of complex anal fistulas
- Treatment of rectovaginal fistulas
Clinical Applications
- Sphincter-sparing repair of selected complex anal fistulas
- Occlusion of an anal fistula tract after appropriate drainage and preparation
- Sphincter-sparing treatment of selected rectovaginal fistulas
- Use as a bioabsorbable scaffold for tissue regeneration across a fistula tract
Reported off-label uses
- Treatment of refractory fistulas associated with Crohn disease has been reported in clinical practice, but use should be considered off label when it falls outside the device labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of prospective studies, systematic reviews, and case reports, totaling 9 studies from 2012 to 2021. These studies evaluate the efficacy and safety of the Gore Bio-A Fistula Plug in various clinical settings.
Reported Outcomes
Published studies report mixed outcomes regarding the efficacy of the Gore Bio-A Fistula Plug. Some studies indicate successful fistula closure, while others suggest variable results. The device has been used in both anal and rectovaginal fistulas with differing success rates.
Safety Profile
Reported complications include infection and plug extrusion. Some studies noted no significant adverse events, while others highlighted the need for careful patient selection to minimize risks.
Evidence Limitations
The evidence is limited by small sample sizes and variability in study design. Further research is needed to establish standardized protocols and long-term outcomes for the use of the Gore Bio-A Fistula Plug.
Practical Considerations
- The plug must be selected and trimmed to fit the length and diameter of the prepared fistula tract; available sizes depend on the specific product configuration.
- The device is intended for placement by a qualified clinician after the fistula tract has been identified, drained and prepared according to the surgical technique.
- It is bioabsorbable and is not intended to remain permanently as an implant; the timing of absorption and tissue remodeling can vary.
- MRI safety should be confirmed in the current manufacturer’s instructions for use. A device-specific MRI designation should not be assumed from the fact that the material is bioabsorbable.
- Active uncontrolled infection, undrained abscess, unsuitable tract anatomy or inability to adequately prepare the tract may make placement inappropriate. Patient selection and management of the underlying disease remain important.
Frequently Asked Questions
What are the clinical indications for Gore Bio-A Fistula Plug?
The device is indicated for the treatment of complex anal and rectovaginal fistulas, particularly in cases where sphincter preservation is desired.
What outcomes have been reported in clinical studies?
Studies report mixed outcomes, with some indicating successful fistula closure and others showing variable efficacy.
What complications have been reported?
Reported complications include infection and plug extrusion, though some studies noted minimal adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.