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Stent for pseudocysts of pancreas to be marketed in the US
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The FDA will allow the marketing of the AXIOS Stent and Delivery System for the treatment of pseudocysts of the pancreas, according to a press release.
This is the first stent designed for the drainage of pancreatic pseudocysts by developing a new and temporary opening between the pancreas and the gastrointestinal tract.
Most pseudocysts are small and resolve on their own, according to the press release. However, some can grow to 7 cm to more than 50 cm wide, and can become infected.
“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 a press 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 agency’s review of the stent, manufactured by Xlumena, Inc., included 33 patients. The stents were considered successful 90.9% of the time and 97% of stents stayed in place for the duration of pseudocyst treatment (up to 60 days), according to the press release. Adverse events included abdominal pain, nausea and vomiting.
For more information:
FDA Medical Devices. Accessed Dec. 20, 2013.