The BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non branching fistulas in ano via tissue apposition. BH201X1 is a single unit of the BioHealx Anal Fistula Device. Each single unti contains a single absorbable implant preloaded into a single use delivery system. It is provided sterile and is intended for single use. BH201X1 can be provided as a single unit or as a multipack of 5 units in a box.
A bioabsorbable, animal-derived substance intended to be implanted into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue. It consists primarily of an animal-derived matrix structure (e.g., made of collagen) that provides a scaffold for cell migration and growth, and which is gradually incorporated into and remodelled by host tissue. The material is typically preloaded in a disposable syringe.
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