EndoFix™Tissue Fixation System

The EndoFix Tissue Fixation System is an endoscopic device for approximating soft tissue in the gastrointestinal tract. It anchors the gallbladder to the stomach or duodenum to facilitate placement of a luminal apposing metal stent (LAMS) for EUS-guided gallbladder drainage. The system consists of a tissue fixation device that deploys a suture-based implant through an 18-gauge needle, and a suture locking device that secures and cuts the suture once tissue approximation is complete.

The EndoFix TFS is delivered endoscopically through the scope (unlike the percutaneous Entuit predicate) with an 18-gauge adjustable needle penetrating up to 10 cm, compatible with echoendoscopes having 3.2 mm working channels. It uses polyester and polypropylene suture implants (4 segments of 0.75 mm × 12.5 mm) with a PEEK suture lock (2.4 mm diameter × 8 mm), differs from Entuit's metallic anchor but matches X-Tack's use of polymeric locking mechanisms. The device deploys one or two implants and is MRI-compatible with no metallic components.

ISO 19993 (biocompatibility testing for limited and permanent patient-contacting components), ISO 11135 (sterilization validation for ethylene oxide), and ISO 10993-1 (biological evaluation of medical devices). The device was sterilized to a Sterility Assurance Level (SAL) of 10⁻⁶ using validated ethylene oxide methods.

The EndoFix TFS achieves substantially equivalent intended use by combining characteristics of both predicates: like Entuit, it uses suture-based tissue fixation with a locking mechanism to maintain apposition during interventional procedures; like X-Tack, it is delivered endoscopically through-the-scope for internal tissue approximation. All three devices share the fundamental principle of deploying an implant fixed to tethered nonabsorbable suture, then tensioning and securing it with a locking mechanism. The core technological differences (endoscopic vs. percutaneous delivery, material composition) are already established in legally marketed predicates and do not introduce new safety or effectiveness questions.