Stent OK’d for marketing to treat pseudocysts of pancreas

The FDA announced it will allow marketing of the Axios Stent and Delivery System to treat fluid- and tissue-filled cavities in the pancreas and adjacent to the stomach or small intestine, according to a news release.

“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,” Christy L. Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release. “The Axios Stent provides a new option for physicians to effectively treat pseudocysts with a less invasive intervention than surgical removal of the pseudocyst.”

The Axios stent (Xlumena) is a tightly compressed wire mesh tube with a silicone covering, the release said. It is enclosed with a catheter and placed into the stomach using an endoscope via the patient’s mouth.

After the stent expands, it is designed to allow contents of the pseudocyst to drain into the stomach, after which the physician can use standard endoscopic tools to remove the stent.

The stent was reviewed by the FDA via the de novo premarket review pathway intended for a certain low- to moderate-risk devices that are not substantially equivalent to already legally marketed devices. In a clinical study of 33 participants, 93% of the stents remained open to allow drainage of the pseudocysts, and all stents were removed without consequence. Adverse events included nausea, vomiting and abdominal pain.