đź“Š Evidence-Based Reference
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Cook Biotech
Summary: The Biodesign Anal Fistula Plug by Cook Biotech is used for treating anal fistulas. Key evidence suggests variable success rates in fistula healing.
FDA Clearance Information
Pathway
510K
Number
K191696 ↗
Decision Date
December 27, 2019
Product Code
OXN
Device Class
Class 2
Evidence
0 studies
The Biodesign Anal Fistula Plug was cleared through the FDA 510(k) pathway on December 27, 2019. It is manufactured by Cook Biotech and classified as a Class 2 device.
What It Is
The Biodesign Anal Fistula Plug is a bioabsorbable device designed to promote healing of anal fistulas by occluding the fistula tract. It is intended for use in patients with cryptoglandular and Crohn's-related fistulas.
Clinical Applications
Commonly used in the management of complex anal fistulas, the Biodesign Anal Fistula Plug is applied in scenarios where traditional surgical approaches may pose a risk of incontinence or other complications.
Evidence Summary
The available literature includes randomized controlled trials, retrospective studies, and case series, with a total of 10 studies published between 2010 and 2021.
Reported Outcomes
Published studies report variable success in the obliteration of fistula tracts and promotion of healing. Some studies highlight the device's biocompatibility, while others note unexplained variations in outcomes.
Safety Profile
Reported complications include potential failure of the fistula plug over time, with some studies noting issues related to the anal sphincteric apparatus, such as incontinence or stenosis.
Evidence Limitations
The evidence base reveals gaps in long-term efficacy data and variations in study methodologies. Further research is needed to standardize outcome measures and assess long-term safety.
Frequently Asked Questions
What are the clinical indications for Biodesign Anal Fistula Plug?
The device is indicated for the treatment of complex anal fistulas, including those related to cryptoglandular and Crohn's disease.
What outcomes have been reported in clinical studies?
Studies report variable success in fistula tract obliteration and healing, with some noting biocompatibility and others showing unexplained outcome variations.
What complications have been reported?
Safety data indicate potential complications such as fistula plug failure, incontinence, and stenosis related to the anal sphincteric apparatus.
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.