THD GateKeeper®: surgical equipment
The THD GateKeeper® surgical device consists of a Delivery System and 6 Dispensers which contain each the sterile self-expanding prostheses.
Each Dispenser is equipped with a cannula for inserting the implants into the intersphincteric space. The THD GateKeeper® sterile prosthesis are inserted between the internal and external anal sphincter through the specific Delivery System.
The Delivery System and Dispenser, in combination with the Portable EAUS Module enable correct placement and verification of the prosthesis without the need for additional equipment.
THD GateKeeper®: features and benefits
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.
- single patient use
- ergonomic handle
- practical LED indicators to guide and indicate the different surgical phases
- sterile (supplied inside the Dispenser)
- 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. Due 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 clinical evidence with medium and long-term follow-up. No short- or long-term complications have been reported following implantation1. 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
- 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
- Multicentre observational study of the Gatekeeper™ for faecal incontinence, C. Ratto, S. Buntzen et al, BJS 2016; 103: 290–299
- 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