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Xlumena Receives CE Mark for NAVIX™, Second Product to Enter European Market
Date:6/30/2011

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 trea
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SOURCE Xlumena, Inc.
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