EMA approves Axios Stent system (Xlumena) for GI surgery

The EU has given CE Mark approval to market the Axios Stent and Delivery System, from Xlumena, for biliary tract drainage in GI Surgery. The Axios system gives endoscopists a minimally-invasive tool to create a secure connection between the gallbladder or bile duct and the gastrointestinal tract. The Axios Stent is delivered under endoscopic ultrasound guidance using a specially-designed delivery system. Once in place, the flanged, fully-covered stent creates an anastomosis, providing a secure pathway between the gastrointestinal tract and the common bile duct or gallbladder for bile drainage. Stones may pass through the stent, and endoscopic intervention can be performed across the stent. The CE Mark approval also covers the AXS-06-08, a new stent 6 mm in diameter with an 8 mm saddle length. The device was previously approved for the treatment of pancreatic pseudocysts.