Xlumena, Inc. announces that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts. The enhanced indication gives endoscopists a new minimally-invasive tool to create a secure connection between the gallbladder or bile duct and the gastrointestinal tract. Clinical research is showing that treatment with the AXIOS Stent successfully restores bile flow and relieves symptoms in patients with biliary inflammation, strictures, and stones. This is significant, as biliary obstruction is estimated to occur in 5 of every 1,000 Americans. The CE Mark approval also covers the AXS-06-08, a new stent 6 mm in diameter with an 8 mm saddle length.
Kenneth Binmoeller, MD, Medical Director of Interventional Endoscopy Services (IES) at California Pacific Medical Center and Xlumena's Chief Medical Officer, commented: "Creation of an internal anastomosis between the biliary and gastrointestinal tracts opens up a new frontier for the endoscopic treatment of bile duct and gallbladder diseases. The AXIOS Stent essentially provides the equivalent of a surgical biliary bypass. It complements – and may eventually replace – our current methods of accessing the bile duct by endoscopic retrograde cholangiopancreatography (ERCP), which may fail for a number of reasons and may be complicated by post-ERCP pancreatitis. This approach should not have those limitations."
Manuel Perez-Miranda, MD, Head of Gastroenterology at Rio Hortega University Hospital in Valladolid, Spain frequently uses the AXIOS Stent as part of an acute cholecystitis (inflamed gallbladder) research study treating patients who are not candidates for surgery. "We have had great success with the more than two dozen AXIOS Stents we have placed to date. Very sick patients tolerate the procedure well and see immediate resolution of their symptoms, without the need for more invasive interventions."
Takao Itoi, MD of Tokyo Medical University Hospital reported his clinical success using the AXIOS stent in the April issue of Gastrointestinal Endoscopy. He has recently started using the 6x8 mm stent to treat bile duct obstruction. "Because the bile duct is easily visualized and accessed from the duodenum, it is a straightforward process to place the 6x8 mm stent. This provides a bypass to the obstruction and, as with the cholecystitis patients I have treated, the symptoms resolved quickly and have not returned. It is exciting to have this new approach to treat the biliary 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 AXIOS Stent and Delivery System is currently being sold in Europe and is not commercially available in the United States.