Xlumena (Mountain View, CA) has won FDA approval of its AXIOS stent and delivery system for the drainage of pancreatic pseudocysts. The stent is led down the patient’s upper GI tract and is placed between the pancreatic pseudocyst and the gastrointestinal tract using both endoscopic and imaging guidance. Once properly positioned, the stent is deployed to create an anastomotic conduit to allow the pseudocyst to be drained. Once the fluid has been evacuated, the stent is removed using standard endoscopic tools.
The stent is designed with two large bilateral anchors at each end to help maintain apposition and prevent stent migration. It also features a large lumen diameter to maximize fluid drainage and gives physicians the ability to pass endoscopic tools into the pseudocyst for additional cleaning. The stent is also fully covered with silicone to prevent fluid leakage and tissue in-growth, and to facilitate stent removal. Clinical studies showed 86% of treated patients had at least a 50% reduction in pseudocyst size.
The AXIOS comes in four models, each with a unique combination of lumen diameter and saddle length. It currently has European CE Mark approval for the treatment of pancreatic pseudocysts and for biliary drainage.
Video showing how the AXIOS is implanted:
Flashbacks: Endoscopic AXIOS Stent System for Pancreatic Pseudocysts Gets European Approval; Xlumena Receives CE Mark Approval for NAVIX Pancreatic Pseudocyst Access Device
Product page: AXIOS Stent and Delivery System…
FDA press release: FDA allows marketing of new stent for treating pseudocysts of the pancreas…