FDA Approves Stent to Treat Pancreatic Pseudocysts
First stent specifically designed for drainage of a pancreatic pseudocyst
THURSDAY, Dec. 19, 2013 (HealthDay News) -- The AXIOS Stent and Delivery System has been approved by the U.S. Food and Drug Administration to treat pancreatic pseudocysts, the FDA said in a news release.
The AXIOS stent is a wire mesh tube that can expand to more than 1/2-inch diameter. It was evaluated among 33 clinical study participants who had a pancreatic pseudocyst at least 6 centimeters in diameter. Physicians were able to successfully place the stents 90.9 percent of the time, and 97 percent of stents that were successfully implanted stayed in place for the duration of treatment (up to 60 days).
According to the FDA, 93 percent of the stents remained open to allow for drainage during treatment, and 86 percent of pseudocysts treated shrank by half or more. The most common side effects of the stent included abdominal pain, nausea, and vomiting. The stents were all removed without injury to the surrounding tissue.
"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 Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement. "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 device is produced by Xlumena Inc. of Mountain View, Calif.