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Xlumena Receives CE Mark for Revolutionary AXIOS(TM) Stent and Delivery System


5/5/2011 2:43:33 PM

MOUNTAIN VIEW, Calif., May 5, 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 revolutionary AXIOS™ Stent and Delivery System (AXIOS). The AXIOS is the first stent designed for endoscopic ultrasound-guided translumenal therapy and is indicated for drainage of pancreatic pseudocysts. Having achieved this important milestone, Xlumena will begin a targeted commercial launch of the AXIOS in select European markets.

"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.

"AXIOS leverages the expertise and vision of the interventional endoscopy community. It represents a new frontier in endoscopic therapy that uses ultrasound to guide intervention outside of the gastrointestinal tract. This avoids more invasive treatments such as surgery," commented Michael Allen, Xlumena's President and CEO. "Xlumena is committed to advancing endoscopic treatment options through the development of safe, efficient and easy to use technologies."

About the AXIOS Stent and Delivery System

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. To view an animation of the AXIOS Stent and Delivery System, visit http://www.vimeo.com/xlumena/axios

About Xlumena

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, the NAVIX Access Device (FDA cleared), visit http://www.vimeo.com/xlumena/navix

Contact: Witney McKiernan 650.961.9900

SOURCE Xlumena, Inc.



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