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.
The approval was based on a 33-patient study of subjects with pancreatic pseudocysts of at least 6cm in diameter, according to the FDA. Trial data showed that the stent was successfully placed 90.0% of the time, with 97% of those staying in place for the duration of treatment (up to 60 days), the federal watchdog agency said.