EndoFast Reliant SCP
The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during laparotomy or laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices; each preloaded with a spider fastener composed of metal and includes the MRI Safety Information that is stated in the labeling.
- Plastic Handle; connects to the Fixation Device.
- Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.
The device is introduced through a 5mm trocar in a laparoscopic approach.
The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.
MRI Safety Information
Non-clinical testing has demonstrated the Spider Fastener is MR Conditional. A patient with this device can be scanned safely after placement under the following conditions:
- Static magnetic field of 3.0 Tesla or less.
- Spatial gradient field of 720-Gauss/cm (7.2 T/m) or less.
- Maximum MR System reported whole-body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode).
- 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.
Under the scan conditions defined above, the Spider Fastener is expected to produce a maximum temperature rise of less than 2.7°C after 15 minutes of continuous scanning.
In phantom testing, the image artifact caused by the device extended approximately 10 mm from the Spider Fastener when imaged with a Gradient Echo scan sequence using a 3 Tesla MRI system.