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gore bio-a fistula plug
W.L. Gore & Associates
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
510K
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.
Clinical Applications
Commonly used in the management of complex anal fistulas, particularly in patients where sphincter preservation is desired. It is also used in cases of refractory rectovaginal Crohn's fistulas.
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.
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.