Xlumena Receives CE Mark for NAVIX™, Second Product to Enter European Market The NAVIX will be introduced into Europe alongside Xlumena's first CE Mark approved device, the AXIOS Stent and Delivery System
MOUNTAIN VIEW, Calif., June 30, 2011 /PRNewswire/ -- Xlumena, Inc., a privately-held provider of innovative technology for the interventional endoscopist and endoscopic surgeon, announced today that it has received CE Mark approval for its NAVIX™ Access Device (NAVIX). The NAVIX is a multi-function system that enables exchange-free access, tract dilation and delivery of two guidewires during endoscopic pancreatic pseudocyst drainage. The NAVIX will join the AXIOS Stent and Delivery System as Xlumena's second product available to select physicians within Europe.
The NAVIX was designed to address the existing challenges with endoscopic transmural (through the gastrointestinal tract) pseudocyst drainage, a procedure that is technically challenging and requires multiple device exchanges during which pseudocyst access can be lost. The NAVIX is "exchange-free" which simplifies an often long and cumbersome procedure and eliminates the current trial and error approach of using different tools. The NAVIX is 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 CE Mark approval for the NAVIX is a milestone along Xlumena's path to develop innovative, high-quality devices that will expand the ability of interventional endoscopists to provide very minimally invasive care at a lower cost. The NAVIX has been successfully used in over 80 cases in the United States and we look forward to providing endoscopists in Europe with an exceptional device that will improve their ability to treat patients with this condition," commented Michael Allen, Xlumena's President and CEO.
Kenneth Binmoeller, MD, Director of Interventional Endoscopy Services at California Pacific Medical Center in San Francisco, California, added, "Interventional endoscopists are in need of innovative tools to enable lesser invasive endoscopic treatments of diseases that have been treated surgically in the past. 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."
About the NAVIX Access Device
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. To view an animation of the NAVIX, visit http://www.vimeo.com/xlumena/navix.
Xlumena is the leader in the development of image-guided therapeutic endoscopy products, specializing in advanced implants and devices for a new, rapidly growing field of medicine. Collaborating with top physicians in the field, Xlumena focuses on technologies that advance therapy to the next level. These innovations may enable numerous translumenal therapeutic procedures, helping transform complex surgeries into outpatient events.
To view an animation of Xlumena's first product available in Europe, the AXIOS Stent and Delivery System (CE Mark approved), visit http://www.vimeo.com/xlumena/axios.
SOURCE Xlumena, Inc.