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The BioHealx Technology

The BioHealx® Anal Fistula Device is an FDA
De Novo-authorized device designed to 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.

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The BioHealx Solution 

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 within the sphincter muscle complex, providing extraluminal compression, 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). 

Illustration of the Signum Surgical medical instrument inserted into a the anal cavity, showing anodermal flaps created by the biohealx device to deliver the anal fistula implant.

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.

1
Medical illustration showing a Signum Surgical device being deployed as an anal fistula implant on the fistula tract and internal sphincter muscle, in this cross-sectioned area of the anus.

The BioHealx delivery device is deployed to deliver the implant around the outside of the fistula tract within the sphincter muscle complex.

2
Diagram of the BioHealx anal fistula implant placed around an anal fistula tract, showing sphincter muscle and tissue layers with the bioabsorbable implant in place.

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.

3
4

Implant maintains strength for ~6 weeks and absorbs in 6 to 12 months

BioHealx System

Delivery System

  • Single Use
  • Pre-loaded delivery device
  • Implant deployment by rotating actuator
A close-up of a metal tool, a surgical delivery device with a spiraled tip next to a small, helical piece of bioabsorbable material which is the anal fistula implant, all on a white background, showcasing advanced Signum Surgical technology.

BioHealx Implant

  • ID 4mm tapers to 2mm
  • OD 5mm
  • Length 9.2mm
  • Barbs prevent retrograde migration
  • Material: PLGA
  • Bioabsorbable in 6-12 months
A purple, helical structure with sharp angles and twists stands vertically against a plain white background, evoking the innovative design ethos of Signum Surgical anal fistula implant and absorable device.

Indication for Use

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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