FDA Clears Axios, First Stent for Pancreatic Pseudocysts

Megan Brooks

Disclosures

December 19, 2013

The first stent specifically designed to treat pancreatic pseudocysts yesterday was cleared for marketing by the US Food and Drug Administration (FDA).

The Axios stent and delivery system from Xlumena Inc drains pancreatic pseudocysts by creating a new, temporary opening between the pancreas and the gastrointestinal tract.

It has 2 components: the catheter-based delivery system and an implantable stent. Under combined endoscopic and imaging guidance, the catheter is advanced, the stent deployed, and the catheter withdrawn.

"The stent produces endoscopically what until now has only been possible through surgery. Creating an anastomotic conduit between two lumens enables blockages and strictures to be bypassed and large fluid collections to be drained," the company explains on its Web site. Once the pseudocyst has drained and decreased in size, the stent is removed.

New Less Invasive Option

As part of its evaluation of the device, the FDA reviewed a study of 33 patients with pancreatic pseudocyst at least 6 cm in diameter treated with the Axios stent and followed for up to 6 months after stent removal.

In the study, physicians successfully placed the stents 90.9% of the time, and 97% of stents successfully implanted stayed in place for the duration of pseudocyst treatment (up to 60 days), the FDA said in a press release.

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. 

Pancreatic ducts may become blocked due to gallstones or injury to the pancreas, causing enzymes that normally drain into the small intestine to be released directly into the pancreas, which can cause a pseudocyst to form, the FDA notes. While most pseudocysts are small and resolve on their own, some may become infected with bacteria.

"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 the 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," Foreman added.

The FDA reviewed the Axios stent and delivery system through the de novo premarket review pathway, which is used for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device, the agency said.

More information about the announcement is available on the FDA Web site.

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