The FDA approves Xlumena's Axios stent for treating pancreatic pseudocysts under the agency's de novo review pathway. Xlumena won FDA approval to market its Axios stent and delivery system, landing approval through the FDA's less-stringent de novo review pathway. The stent is the 1st specifically designed for the drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
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