The EndoFast Reliant System core technology is the "Spider Fastener" technology. This technology and implantable device has already been in commercial use.
The Spider Fastener consists of a base and 6 needles, shaped in a rounded angle (not sharp) at the tips (14mm total diameter). The fastener has a very shallow penetration of only 2mm in depth. Once in the right anatomical site, it is attached by pressing the trigger of the EndoFast handle and releasing it.
A specially designed retractor helps easier delivery to the appropriate location.
If repositioning or re–tensioning is needed, the fastener can be easily retrieved using a specially designed extraction device, this extraction device is an integral component in each EndoFast MN kit. The fastener will be taken out through the same channels as going in, thus causing no damage to the sling or tissue.
The EndoFast™ fastening technology utilizes a unique, small fastener deployed into soft tissue, in order to attach and to reinforce the tissue. This Spider Fastener™ technology ensures optimal fixation of mesh to tissues:
- Attachment to soft tissue – including Ligament, Muscle and Fascia depending on surgeon's discretion
- Pullout force - Minimum of 1.5 kg per fastener right after time of fastener deployment
- Shallow penetration – the Spider Fastener penetration into the tissue is only 2mm deep, decreasing the risk of damage to visceral organs
- Reversibility - Fastener can be easily retrieved intra-operatively if needed; the unique fasteners technology enables retrieval of fasteners without causing damage either to the tissue or mesh and without causing pain due to the shallow penetration. It enables repositioning and enhances procedure flexibility
- Single hand fixation device - Small grips on both sides of EndoFast's fixation device designed to hold the mesh in place during access to the fixation anatomic landmark. When the fastener is deployed, the grips retrieve into the body of the fixation device, releasing the surgical mesh. Thus, Mesh attachment to the fixation device is done prior to entering the pelvic cavity, leaving one hand free for palpation and guidance to the anatomical site, enabling Single Hand Use. Short spikes on the tip and use of free hand for guidance help avoid tissue entrapment.
- Maneuverability in the narrow pelvic cavity is made easy and convenient.
- Amount of mesh used - mass load of mesh is low. The mesh arms are short and compact help to reduce level of tention and friction against the tissue. Specially designed retractor helps to reach anatomical tissue and avoid tissue entrapment
- The Spider Fastener is MRI compatible
MRI Safety Information
- Non-clinical testing has demonstrated the Spider Fastener is MR Conditional. A patient with this device can be scanned safely immediately after placement under the following conditions:
- Static magnetic field of 3.0Tesla or less.
- Spatial gradient field of 720-Gauss/cm (7.2 T/m) or less.
- Maximum MR System reported, whole body average specific absorption rate (SAR) of 4 W/kg First Level Controlled Operating Mode for 15 minutes of scanning (per pulse sequence).
- Do not bring the Fixation Device and Fixation Device Handle into the MRI environment. They have not been evaluated for safety in the MRI environment.
In non-clinical testing, the Spider Fastener produced a temperature rise of less than 1.8°C at a maximum whole body averaged specific absorption rate (SAR) of 2.7 W/kg as assessed by calorimetry for 15 minutes of MR scanning in a field strength 3-Tesla/128-MHz, model Excite, HDx, manufacturer General Electric Healthcare, Milwaukee, WI, software version 14X.M5x MR scanner.