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biohealx anal fistula device
Signum Surgical
Summary: The BioHealx anal fistula device is designed for the treatment of anal fistulas, focusing on primary healing and continence preservation. Key evidence includes a study demonstrating effective healing rates.
FDA Clearance Information
Pathway
510K
Number
DEN240007 ↗
Decision Date
July 1, 2024
Product Code
QML
Device Class
Class 2
Evidence
0 studies
The BioHealx anal fistula device by Signum Surgical was cleared through the FDA 510k pathway on July 1, 2024. It is classified as a Class 2 device under product code QML.
What It Is
The BioHealx device is a bioabsorbable implant used in the treatment of anal fistulas. It works by compressing and closing the fistula tract, promoting healing while preserving continence.
Clinical Applications
The device is commonly used in cases of non-branching transsphincteric anal fistulas. It is particularly applicable in scenarios where preserving anal continence is a priority.
Evidence Summary
The literature includes two studies: a prospective assessment of the BioHealx device and a post-market surveillance study. The studies focus on healing rates and functional outcomes.
Reported Outcomes
Published studies report effective primary healing rates of non-branching transsphincteric fistulas with the BioHealx device. The BAFT procedure demonstrated promising medium-term outcomes in terms of healing and continence preservation.
Safety Profile
Reported complications include typical post-surgical risks, but specific adverse events are not detailed in the provided evidence. Further safety data is expected from ongoing surveillance studies.
Evidence Limitations
The current evidence is limited by the small number of studies and lack of long-term data. Further research is needed to confirm the device's efficacy and safety over extended periods.
Frequently Asked Questions
What are the clinical indications for BioHealx anal fistula device?
The device is indicated for the treatment of non-branching transsphincteric anal fistulas, with a focus on preserving continence.
What outcomes have been reported in clinical studies?
Studies have reported effective primary healing rates and continence preservation in patients treated with the BioHealx device.
What complications have been reported?
Safety data from studies is limited, but typical post-surgical risks are expected. Specific adverse events are not detailed in the provided evidence.
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.