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surgisis biodesign enterocutaneous fistula plug
Cook Biotech
Summary: The Surgisis Biodesign Enterocutaneous Fistula Plug is a device used for the treatment of enterocutaneous fistulas. It is primarily used in complex anal and rectovaginal fistulas. Key evidence highlights its efficacy in reducing fistula recurrence.
FDA Clearance Information
Pathway
510K
Number
K082682 ↗
Decision Date
February 27, 2009
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The Surgisis Biodesign Enterocutaneous Fistula Plug was cleared by the FDA via the 510(k) pathway on February 27, 2009. It is manufactured by Cook Biotech and classified as a Class II device.
What It Is
The Surgisis Biodesign Enterocutaneous Fistula Plug is a bioabsorbable device designed to facilitate the closure of enterocutaneous fistulas. It is intended for use in patients with complex anal and rectovaginal fistulas, providing a scaffold for tissue regeneration.
Clinical Applications
Commonly used in the treatment of complex anal and rectovaginal fistulas, the device is applied in scenarios where traditional surgical methods may pose a risk of complications such as incontinence or stenosis.
Evidence Summary
The available literature includes randomized controlled trials and case series, with studies conducted between 2010 and 2021. The evidence base consists of approximately four studies, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that the Surgisis Biodesign Enterocutaneous Fistula Plug is effective in reducing fistula recurrence rates. It has been shown to improve long-term outcomes in patients with cryptoglandular and Crohn's fistulas. The device is associated with a high success rate in closing complex fistulas.
Safety Profile
Reported complications include potential failure of the fistula plug over time. However, the studies reviewed did not provide detailed adverse event data, indicating a need for further research into long-term safety outcomes.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to assess long-term efficacy and safety, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Surgisis Biodesign Enterocutaneous Fistula Plug?
The device is indicated for the treatment of complex anal and rectovaginal fistulas, particularly in cases where traditional surgical methods may lead to complications.
What outcomes have been reported in clinical studies?
Clinical studies have reported a reduction in fistula recurrence rates and improved long-term outcomes in patients with cryptoglandular and Crohn's fistulas.
What complications have been reported?
Reported complications include potential failure of the fistula plug over time, though detailed adverse event data is limited in the available studies.
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.