Xlumena Receives CE Mark Approval for NAVIX Pancreatic Pseudocyst Access Device

Xlumena Receives CE Mark Approval for NAVIX Pancreatic Pseudocyst Access Device

There is a hope for patients and clinicians who are treating pancreatic pseudocysts, a terrible and debilitating condition in patients recovering from acute pancreatitis. Xlumena of Mountain View, California won the CE Mark for its AXIOS Stent and Delivery System, an endoscopic ultrasound-guided translumenal system. By performing a minimally invasive procedure with AXIOS, physicians can establish a drainage conduit for pseudocysts, potentially decreasing chances for complications, such as secondary infections or bleeding.

1142xho6 Endoscopic AXIOS Stent System for Pancreatic Pseudocysts Gets European ApprovalFrom the announcement:

“The AXIOS Stent opens up a frontier of new treatments in and around the gastrointestinal tract. Not only does the AXIOS Stent create a large, secure drainage pathway – equivalent to a surgical anastomosis – it also provides an access port to pass the endoscope into the duct or lumen cavity for targeted therapy. This technology has the potential to expand the role of endoscopy in treating a variety of disorders of the pancreatic and biliary system,” stated Kenneth Binmoeller, MD, Director of Interventional Endoscopy Services at California Pacific Medical Center in San Francisco, California.

Unlike tubular stents used for bile and pancreatic duct drainage, the AXIOS Stent is designed to hold two lumens in apposition for translumenal drainage. The bilateral anchors of the AXIOS Stent prevent movement and migration and the large-diameter Stent lumen ensures drainage. The AXIOS is fully covered to prevent leakage across the stent and tissue ingrowth and facilitate removal. The AXIOS Stent comes pre-loaded in a specially-designed Delivery System and is easily deployed by a single operator.

The AXIOS Stent is fully-covered, self-expandable and available in multiple lumen diameters (15mm, 10mm, 8mm and 6mm) and lengths (10mm, 6mm and 4mm) to ensure a custom fit. The Delivery System is ergonomic and allows the interventional endoscopist to control and precisely deliver the AXIOS to the intended target using a single hand.

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.

Source : http://medgadget.com/2011/05/endoscopic_axios_stent_system_for_pancreatic_pseudocysts_gets_european_approval.html

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