THD GateKeeper® for faecal incontinence surgery - THDLAB - COM

  • THD Gatekeeper®: surgical device
  • THD GateKeeper®: features and advantages

THD GateKeeper®: surgical device

The THD GateKeeper® surgical device consists of an implant system called Delivery System and of 6 Dispensers containing an equal number of self-expanding sterile prostheses.

Each dispenser is equipped with a cannula for inserting the implants in the intersphincteric space. The THD Gatekeeper® sterile implants are inserted between the internal and external anal sphincter through the specific Delivery System.

Delivery System and Dispenser, in combination with the EAUS Module for verifying the correct positioning of the prosthesis, allow performing the surgical procedure THD GateKeeper® without the need for additional equipment.


THD GateKeeper®: features and advantages

All the components of the THD® GateKeeper device are designed with the highest quality standards to ensure the highest level of comfort and safety for the surgeon and patient and to reduce the risk of infections and surgical complications.

  • Delivery system
    • sterile
    • single patient
    • ergonomic handle
    • practical LED indicators to guide the different surgical phases
  • Dispenser
    • sterile
    • single-use
  • Self-expanding prostheses
    • sterile (supplied inside the dispensers)
    • biocompatible
    • non-allergenic
    • non-carcinogenic
    • non-degradable
    • non-pyrogenic
    • non-immunogenic
    • biologically inert

The THD GateKeeper® prostheses are made with a self-expanding material, equipped with a shape memory. This material is able to grow in volume through the absorption of body fluids.

After 24-48 hours from implantation, the prostheses expand by absorbing the physiological fluids and increase their volume up to 550% of their original size. Thanks to the "shape memory" effect, the implants are able to return to their initial shape following the movement of the anal sphincters. In this way it is possible to maximise anal continence results.

The efficacy and safety of the THD GateKeeper® implants are supported by an ample clinical evidence with medium and long-term follow-ups. No short- or long-term complications have been reported following the implant1. The rare cases of implant migration have been easily resolved by immediate re-surgery and have not compromised the substantial effectiveness of the results.2, 3


  1. Outcomes of GateKeeper TM prosthesis implantation for the treatment of fecal incontinence: a multicenter observational study, L. Trenti, S. Biondo, F. Noguerales. J. Nomdedeu et al., Techniques in Coloproctology (2017) 21: 963-970
  2. Multicentre observational study of the Gatekeeper™ for faecal incontinence, C. Ratto, S. Buntzen et al, BJS 2016; 103: 290–299
  3. Ultrasonographic evidence of Gatekeeper™ prosthesis migration in patients treated for faecal incontinence: a case series, de la Portilla F, Reyes-Díaz ML, Maestre MV et al, Int J Colorectal Dis. 2017 Mar; 32(3):437-440
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