A novel exchange-free device simplifies pancreatic pseudocyst drainage and reduces the number of necessary devices, while ensuring access is not lost during the procedure.

The NAVIX Access Device was specifically designed and indicated for pancreatic pseudocyst access and tract dilation, and replaces the use of devices that were not intended for this purpose. The system includes an endoscopic trocar that creates an initial incision into the pseudocyst, an anchor balloon that secures access within the pseudocyst, and a dilation balloon that expands the access tract to 10 mm diameter. The device was designed to address the existing challenges with endoscopic transmural pseudocyst drainage, a procedure that is technically challenging and requires multiple device exchanges.

The device enables exchange-free access, tract dilation, and the placement of up to two guidewires into the pseudocyst, which can be used to deploy one or more drainage stents (guidewires and stents not included). The NAVIX handle is ergonomically designed and allows the interventional endoscopist to deploy the device using a single hand. The NAVIX may also be used to create an access tract for placement of the proprietary AXIOS Stent, a drainage stent specifically indicated for transmural pancreatic pseudocyst drainage. The NAVIX Access Device and the AXIOS Stent are products of Xlumena (Mountain View, CA, USA), and have received the European community CE marking.

“Interventional endoscopists are in need of innovative tools to enable lesser invasive endoscopic treatments of diseases that have been treated surgically in the past,” said Kenneth Binmoeller, MD, director of Interventional Endoscopy Services at California Pacific Medical Center (San Francisco, CA, USA). “Xlumena is meeting this need with efficient, reliable solutions. The NAVIX Access Device and the AXIOS Stent are examples of the type of tools that will fundamentally change the way therapy is delivered and improve patient care.”

A pancreatic pseudocyst is a fluid-filled sac in the abdomen, which may also contain tissue from the pancreas, pancreatic enzymes, and blood. Endoscopic transmural pseudocyst drainage is a technically challenging, cumbersome procedure that normally requires multiple device exchanges in a “trial and error” approach using different tools, during which pseudocyst access can be lost.

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