Xlumena’s Stent Approved by the FDA

The U.S. Food and Drug Administration (FDA) has approved a stent and delivery system for infected pancreatic cysts that do not drain on their own and could become life-threatening.

The Axios Stent is a wire mesh tube that can expand to more than half an inch in diameter. It was evaluated among 33 clinical study participants who had a pancreatic pseudocyst at least six centimeters in diameter. Roughly 86 percent of pseudocysts treated shrank by half or more, the FDA said. Common side effects of the stent included abdominal pain, nausea and vomiting.

The AXIOS Stent and Delivery System consists of two components: the catheter-based delivery system and an implantable stent. Under combined endoscopic and imaging guidance, the catheter is advanced, the stent deployed, and the catheter withdrawn. The stent has two large flanges to hold the tissue layers together and a large diameter for effective drainage. It is fully covered to prevent leakage and to enable removal. The stent creates a translumenal conduit between the wall of the gastrointestinal tract (e.g. stomach or duodenum) and a neighboring fluid-filled cavity (e.g. pancreatic pseudocyst, gallbladder, bile duct).

The AXIOS Stent design is intended to overcome the limitations of current options to facilitate drainage. Plastic double pigtail stents (the most widely-used stent for pseudocyst drainage) have small lumen diameters and may occlude and require replacement. Expandable metal stents have a large lumen however the straight configuration makes them prone to migration. The stent ends may also cause tissue injury.

The pancreas, found in the upper abdomen behind the stomach, produces insulin that helps regulate blood sugar and helps digestion. If pancreatic ducts become blocked from gallstones or injury, enzymes that back up into the organ can cause formation of pancreatic pseudocysts. Most resolve on their own, but some become infected and can lead to a life-threatening blood infection, the FDA said.

The stent is made by Xlumena Inc., a venture-backed medical device company founded in 2008. The firm is based in Mountain View, Calif.