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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.

The BioHealx Anal Fistula Device comprises the BioHealx Implant and the Delivery System. The BioHealx implant is designed as a sterile, single use helical, barbed bioabsorbable implant intended to promote healing by primary intention. The BioHealx delivery device is a sterile single-use, disposable delivery device that rotates the implant into the soft tissue surrounding the internal opening of the fistula tract. The BioHealx implant apposes the internal opening of the fistula channel and is held in position by its design geometry. The implant is fully enclosed in the anal sphincter muscle tissue and is not exposed to the ano-rectal canal. The implant retains adequate strength to compress the tissue of the internal opening of a fistula for 4 - 6 weeks and is absorbed within 6 - 12 months.