The BioHealx® Anal Fistula Device is an FDA cleared device designed to minimize anorectal tissue trauma using a bioabsorbable implant that creates tissue apposition thereby closing the fistula tract for optimal primary healing. The BioHealx implant is preloaded onto the delivery system.
The main goal of a surgical procedure is to heal the fistula tract at its origin within the sphincter complex. Current surgical procedures have limited ability to deliver this direct impact on the fistula. The BioHealx Anal Fistula Device is inserted via direct access into the anal canal. It has a unique mechanism of action where the bioabsorbable BioHealx implant closes the fistula tract by compression from the outside of the tract, rather than attempting to occlude the lumen from the inside of the tract like plugs. The device creates tissue apposition, thereby closing the tract (see Figure 1).
Anodermal flaps are created and the guide suture is used to align the delivery device to the internal opening and trajectory of the fistula tract.
The BioHealx delivery device is deployed to deliver the implant around the outside of the fistula tract within the sphincter muscle complex.
The implant has been fully deployed to provide compression closure of the fistula tract within the sphincter complex and the anodermal flaps have been sutured.
Implant maintains strength for ~6 weeks and absorbs in 6 to 12 months
The Signum Surgical BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non-branching fistulas in ano via tissue apposition
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