EndoFast Reliant System
This system employs a novel technology that enables a minimally invasive technique for reinforcement of the vaginal wall using IBI’s Spider Fastener™ technology. The procedure is performed trans-vaginally with direct palpation and visualization, without blind trocar passage. Therefore less trauma and damage to adjacent organs is expected as compared to current conventional techniques.
The system consists of precut mesh and soft-tissue fasteners. The fasteners are easily deployed through narrow spaces into soft tissues, and can support an average weight of 1.0 kg each (far more than required in a typical Pelvic Organ Prolapse repair procedure).
The system also includes an extraction device that allows intra-operative reversibility of fixation without causing damage to the tissue or the mesh.
The EndoFast Reliant™ system is a sterile, single-use system consisting of the following components:
- Operating handle and 5 Fixation Devices preloaded with the Spider Fastener
- The Spider Fastener is provided with a Fastener Retrieval Unit that enables facile retrieval of the deployed Fastener
- An Extraction Device, used with the Fastener Retrieval Unit to ensure facile retrieval of the deployed Fastener.
- The mesh used with the system is a pre-cut Polypropylene monofilament Surgical Mesh
Combining today’s well-established mesh reinforcement techniques with the operative advantages of the EndoFast Reliant™ System will result in overall significant advantages over existing trocar-passing (blind) techniques for both patients and physicians:
- Minimally invasive technology and technique
- Lower trauma and short recovery time
- Stronger tissue attachment and better maintenance of anatomical correction
- Shorter procedure time
- Reversibility and flexibility
- Simpler and safer procedure
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.