Xlumena, a developer of image-guided therapeutic endoscopy products, has received CE mark approval for its NAVIX Access Device.
The NAVIX consists of an endoscopic trocar which 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 to10mm in diameter.
The NAVIX also enables 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 may also be used to create an access tract for placement of Xlumena’s AXIOS Stent which is indicated for transmural pancreatic pseudocyst drainage.
Xlumena president and CEO Michael Allen said the CE mark approval for the NAVIX is a milestone along Xlumena’s path to develop devices that will expand the ability of interventional endoscopists to provide minimally invasive care at a lower cost.