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sis fistula plug
Cook Biotech
Summary: The SIS fistula plug by Cook Biotech is a bioprosthetic device used for treating fistulas. Key evidence suggests its effectiveness in closing fistulas with a low recurrence rate.
FDA Clearance Information
Pathway
510K
Number
K050337 ↗
Decision Date
March 9, 2005
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The SIS fistula plug was cleared by the FDA through the 510(k) pathway on March 9, 2005. It is manufactured by Cook Biotech and classified as a Class 2 device.
What It Is
The SIS fistula plug is a bioprosthetic device made from porcine small intestinal submucosa. It is designed to promote tissue integration and healing in the treatment of fistulas.
Clinical Applications
Commonly used in the treatment of anal, enterocutaneous, and tracheo-esophageal fistulas, the SIS fistula plug provides a minimally invasive option for fistula closure.
Evidence Summary
The literature includes six studies ranging from 2013 to 2024, comprising case reports and trials. These studies explore the use of SIS plugs in various fistula types.
Reported Outcomes
Published studies report successful fistula closure in a majority of cases, with a recurrence rate of approximately 33% in some studies. The device has shown efficacy in both anal and enterocutaneous fistulas.
Safety Profile
Reported complications include fistula recurrence in some patients, with no significant adverse events directly attributed to the device itself.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish long-term efficacy and safety.
Frequently Asked Questions
What are the clinical indications for SIS fistula plug?
The SIS fistula plug is indicated for the treatment of anal, enterocutaneous, and tracheo-esophageal fistulas.
What outcomes have been reported in clinical studies?
Studies have reported successful closure of fistulas with a recurrence rate of about 33% in some cases.
What complications have been reported?
Reported complications include fistula recurrence, with no major adverse events directly linked to the device.
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.