Xlumena (Mountain View, California) has received CE Mark approval for its NAVIX Access Device for pancreatic pseudocyst drainage. The NAVIX enables exchange-free access, tract dilation and delivery of two guidewires during endoscopic drainage. Endoscopic transmural pseudocyst drainage is a technically challenging procedure that normally requires multiple device exchanges during which pseudocyst access can be lost.
The single-device, exchange-free approach of the NAVIX simplifies the procedure and reduces the number of necessary devices, while ensuring access is not lost during the procedure. It may be used in conjunction with the AXIOS drainage stent, which we previously covered here on Medgadget. The NAVIX already received FDA approval two years ago, but up to today, it has only been used in 80 cases across the United States. From the press release:
The NAVIX 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 10mm 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 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 Xlumena’s AXIOS Stent, which is the only drainage stent on the market in Europe specifically indicated for transmural pancreatic pseudocyst drainage.
Company homepage: Xlumena…