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biodesign fistula plug
Cook Biotech
Summary: The Biodesign Fistula Plug by Cook Biotech is a device used for the treatment of fistulae, particularly in enterocutaneous and anorectal cases. Key evidence suggests its utility in minimally invasive management of these conditions.
FDA Clearance Information
Pathway
510K
Number
K170016 ↗
Decision Date
June 21, 2017
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The Biodesign Fistula Plug was cleared through the FDA 510(k) pathway on June 21, 2017. Manufactured by Cook Biotech, it is classified as a Class 2 medical device.
What It Is
The Biodesign Fistula Plug is a bioengineered device designed to promote healing in fistula tracts. It is intended for use in various types of fistulae, including enterocutaneous and anorectal, by providing a scaffold for tissue integration.
Clinical Applications
Commonly used in the management of enterocutaneous, anorectal, and rectovaginal fistulas, the Biodesign Fistula Plug offers a minimally invasive alternative to traditional surgical approaches, aiming to reduce complications such as incontinence.
Evidence Summary
The available literature includes 8 studies, ranging from retrospective reviews to randomized clinical trials, conducted between 2010 and 2022. These studies explore the efficacy and safety of the Biodesign Fistula Plug in various clinical settings.
Reported Outcomes
Published studies report that the Biodesign Fistula Plug is effective in promoting fistula closure and improving patient outcomes in cases of enterocutaneous and anorectal fistulas. The device is noted for its minimally invasive application and potential to reduce surgical complications.
Safety Profile
Reported complications include issues related to device integration and potential for infection. However, the studies generally indicate a favorable safety profile with fewer complications compared to traditional surgical methods.
Evidence Limitations
The evidence is limited by the variability in study design and the relatively small sample sizes in some studies. Further research is needed to establish long-term outcomes and to compare the efficacy of the Biodesign Fistula Plug with other treatment modalities.
Frequently Asked Questions
What are the clinical indications for Biodesign Fistula Plug?
The Biodesign Fistula Plug is indicated for the treatment of enterocutaneous, anorectal, and rectovaginal fistulas, providing a scaffold for tissue healing.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful fistula closure and improved patient outcomes, with a focus on minimally invasive management.
What complications have been reported?
Safety data from evidence indicate potential complications such as device integration issues and infection, though these are less frequent compared to traditional surgery.
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.