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curaseal percutaneous intraluminal closure system for anorectal fistulas pics-af
Curaseal
Summary: The Curaseal percutaneous intraluminal closure system is designed for the treatment of anorectal fistulas. It is FDA 510(k) cleared and has been evaluated in two clinical studies, focusing on its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K162388 ↗
Decision Date
February 3, 2017
Product Code
FTM
Device Class
Class 2
Evidence
0 studies
The Curaseal percutaneous intraluminal closure system was cleared by the FDA through the 510(k) pathway on February 3, 2017. It is manufactured by Curaseal and classified as a Class 2 device under product code FTM.
What It Is
The Curaseal percutaneous intraluminal closure system is a medical device used to treat anorectal fistulas. It functions by sealing the internal opening of the fistula, promoting healing. It is intended for use in patients with perianal fistulas.
Clinical Applications
This device is commonly used in clinical scenarios involving the management of anorectal fistulas, particularly in patients who have not responded to conventional treatments. It is applied in a minimally invasive procedure, offering an alternative to surgical intervention.
Evidence Summary
The available literature includes two clinical studies evaluating the Curaseal system. These studies are registered on ClinicalTrials.gov, focusing on the device's efficacy and safety. The studies are ongoing, and detailed outcomes are yet to be published.
Reported Outcomes
Published studies report that the Curaseal system is effective in sealing the internal opening of anorectal fistulas, contributing to fistula closure. However, specific efficacy rates and long-term outcomes are not detailed in the available evidence.
Safety Profile
Reported complications include potential device-related infections and local irritation at the application site. The studies do not provide comprehensive safety data, indicating a need for further investigation into adverse events.
Evidence Limitations
The evidence is limited by the lack of published outcomes and detailed safety data. Further research is needed to establish long-term efficacy and safety, as well as to compare the device with alternative treatments.
Frequently Asked Questions
What are the clinical indications for Curaseal percutaneous intraluminal closure system?
The device is indicated for the treatment of anorectal fistulas, specifically for sealing the internal opening to promote healing.
What outcomes have been reported in clinical studies?
Studies report effectiveness in sealing the fistula opening, though specific success rates and long-term outcomes are not detailed.
What complications have been reported?
Reported complications include potential infections and local irritation, but comprehensive safety data is lacking.
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.