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biodesign enterocutaneous fistula plug
Cook Biotech Incorprated
Summary: The Biodesign Enterocutaneous Fistula Plug is a medical device used primarily for the management of enterocutaneous fistulae. Key evidence suggests its efficacy in fistula closure with variable success rates.
FDA Clearance Information
Pathway
510K
Number
K150668 ↗
Decision Date
December 9, 2015
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The Biodesign Enterocutaneous Fistula Plug was cleared by the FDA via the 510(k) pathway on December 9, 2015. It is manufactured by Cook Biotech Incorporated and is classified as a Class 2 device.
What It Is
The Biodesign Enterocutaneous Fistula Plug is a biologically derived device designed to aid in the closure of enterocutaneous fistulae. It functions by providing a scaffold for tissue integration and healing.
Clinical Applications
This device is commonly used in clinical scenarios involving enterocutaneous fistulae, particularly when non-operative management has failed. It is applied in both minimally invasive and surgical settings.
Evidence Summary
The available literature includes a range of study types such as RCTs, prospective, and retrospective studies, with a total of 9 studies reviewed. The studies span from 2013 to 2022.
Reported Outcomes
Published studies report variable success rates in the closure of enterocutaneous fistulae using the Biodesign Fistula Plug. Some studies highlight its effectiveness in complex cases, while others note a need for further comparative trials.
Safety Profile
Reported complications include fistula plug failure and recurrence of fistulae. Some studies also mention the need for additional interventions in cases where the plug does not achieve complete closure.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up in some studies. Further research is needed to establish standardized protocols and to compare the plug's efficacy against other treatment modalities.
Frequently Asked Questions
What are the clinical indications for Biodesign Enterocutaneous Fistula Plug?
The device is indicated for the management of enterocutaneous fistulae, particularly when non-operative management has failed.
What outcomes have been reported in clinical studies?
Studies report variable success rates in fistula closure, with some highlighting effectiveness in complex cases.
What complications have been reported?
Reported complications include fistula plug failure, recurrence, and the need for additional interventions.
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.