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.
"Ninety-three percent of the stents remained open to allow for drainage of the pseudocyst for the duration of treatment, and 86% of the treated pseudocysts decreased in size by at least 50%. All stents were removed without injury to the surrounding tissue. Adverse events observed included abdominal pain, nausea and vomiting," the FDA said.
“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. The AXIOS Stent provides a new option for physicians to effectively treat pseudocysts with a less invasive intervention than surgical removal of the pseudocyst,” Christy Foreman, director of the Center for Devices & Radiological Health’s Office of Device Evaluation, said in prepared remarks.
Earlier this month Mountain View, Calif.-based Xlumena closed a $25M Series C round.