EndoFast Reliant MN
The EndoFast Reliant™ MN is an implantable, sub-urethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
The EndoFast Reliant MN is used to reinforce tissues by using the Spider Fasteners. These Fasteners attach a precut surgical sling onto the soft tissue to allow tissue reinforcement.
The EndoFast Reliant MN relies on the existing proven concept of fixation into soft-tissue by using a core technology that is the "Spider Fastener" technology. This technology and implantable device has already been in commercial use for a different indication, pelvic organ prolapse repair, in a system called EndoFast Reliant System.
The EndoFast Reliant MN is a sterile, single-use system consisting of the following components:
- A Handle and five Fixation Devices preloaded with Spider Fasteners. The Spider Fastener is provided with a Fastener Retrieval Unit that enables facile retrieval of the deployed Fastener.
- Pre cut Polypropylene monofilament surgical sling.
- An Extraction Device, used with the Fastener Retrieval Unit to ensure facile retrieval of the deployed Fastener.
The EndoFast Reliant MN for Stress Urinary Incontinence offers the following benefits to both patients and doctors:
- A minimally invasive procedure
- A Trocarless approach
- Fast, simple and safe procedure
- Direct mesh attachment into pelvic soft tissue, potentially reducing intra-operative complications and postoperative morbidity
- Can be performed in the doctor’s office under local anesthesia,
- Ensures accurate suprapubic sling placement with minimal trauma.
* Product is currently in stages of regulatory approvals
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.