Axios Pancreatic Stent Cleared Under FDA’s De Novo Pathway

Under its new de novo pathway, the U.S. FDA has allowed Xlumena’s AXIOS Stent and Delivery System onto the market. AXIOS is a pancreatic stent for treating pseudocysts that form in the pancreas and are next to the stomach or small intestine. This is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.

Background

The pancreatic ducts (that drain enzymes into the duodenum) can become blocked from gallstones or after an injury to the pancreas. Under some circumstances these enzymes end up being released directly into the pancreatic tissue, resulting in one or more pseudocysts. While most pseudocysts are small and resolve on their own, some can become very large (from 7 to more than 50 centimeters wide) and can become infected with bacteria. Infected pseudocysts are almost always painful and may lead to serious blood infections that can be life-threatening.

The AXIOS Stent is a wire mesh tube with a silicone covering. It is endoscopically inserted via an area of the stomach adjacent to the pseudocyst. After creating a small opening in the wall of the stomach and a small opening in the pseudocyst, the surgeon positions the still-compressed stent across both openings, releases the stent and removes the delivery system. Once expanded, the stent allows the contents of the pseudocyst to drain into the stomach.

Once the pseudocyst has drained and decreased in size, the physician can use standard endoscopic tools to remove the AXIOS Stent.

The AXIOS Stent can expand to a larger diameter than other devices on the market (over half an inch), making it potentially less prone to becoming blocked by solid material inside of the pseudocyst. The wider diameter of the AXIOS Stent also allows physicians to pass endoscopic tools into the pseudocyst to clean or remove the contents of both the stent and the pseudocyst.

The FDA reviewed the AXIOS Stent and Delivery System through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

Study data used in the review showed that physicians were able to successfully place the stents 90.9 percent of the time and that 97 percent of stents successfully implanted stayed in place for the duration of pseudocyst treatment (up to 60 days). Ninety-three percent of the stents remained open to allow for drainage of the pseudocyst for the duration of treatment, and 86 percent of the treated pseudocysts decreased in size by at least 50 percent. All stents were removed without injury to the surrounding tissue. Adverse events observed included abdominal pain, nausea and vomiting.

FDA comments

“Pancreatic stents currently on the market are indicated for pancreatic drainage and are to be placed through the pancreas’ existing ducts, but this frequently does not provide adequate drainage of a pseudocyst,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The AXIOS Stent provides a new option for physicians to effectively treat pseudocysts with a less invasive intervention than surgical removal of the pseudocyst.”

EU Regulatory Status: AXIOS is CE marked for both the treatment of pancreatic pseudocysts and drainage of biliary tract.

Source: Xlumena, Inc., FDA

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