Authors: Nicolas Fuentes, M.D., David Pechman, M.D.
EndoGI Medical, Ltd. received FDA approval for EndoGI Biliary Stent System on May 27th, 2020.
The EndoGI Biliary Stent System is a single-use endoscopic preloaded device that allows for the deployment of radiopaque polymer stents into the biliary system for drainage of the biliary system, splinting of the ducts, or to provide patency in a stricture or past a stone. The system has two delivery options: the S-path biliary stent placement solution, which delivers a single stent and the X-path biliary stent placement solution, which delivers two stents in parallel via a single guidewire.
Both systems feature pre-mounted stents with a self-detaching delivery system, allowing clinicians to place stents with decreased procedure time and decreased tissue trauma. The X-path system is capable of deploying two stents, one with a straight body and one end incorporating a 65 degree bend. The preloaded stents are delivered via near-the-wire and over-the-wire methods and are compatible with all 0.035” guidewires. The stents are 10FR and 110mm in length.
Animal performance testing was carried out to validate the ability to deploy two stents. The goals of the study were met and the system was able to successfully deliver 2 stents utilizing a one-step procedure with no local tissue reaction. In addition, stent removal was successful. Biocompatibility and non-clinical performance tests were performed and passed. EndoGI Biliary Stent System was found to be safe and effective without raising new safety or effectiveness concerns in comparison to the primary predicate device.
The FDA determined that the EndoGI Biliary Stent System is substantially equivalent to the predicate device, Advanix™ Biliary Stent with NaviFlex™ RX Delivery System, with similar indications for use, principle of operations, and materials passing all biocompatibility testing.
FDA approve indications for use:
- Drainage of biliary system
- Splinting of biliary system during healing
- Provide duct patency in a stricture
- Provide duct patency past a stone