Navigation Links
Xlumena Receives CE Mark for NAVIX™, Second Product to Enter European Market

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

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 available in Europe, the AXIOS Stent and Delivery System (CE Mark approved), visit

SOURCE Xlumena, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Xlumena Receives CE Mark for Revolutionary AXIOS™ Stent and Delivery System
2. Xlumena, Inc. Closes $7M Series B Venture Financing Round
3. FDA Clears Xlumenas NAVIX(TM) Access Device
4. Althea Technologies Receives FDA Approval to Initiate Commercial Manufacturing
5. BioDrain Streamway® System Receives Positive Evaluations on Two Additional Units
6. Stanmore Receives US FDA Approval for its JTS Non-invasive Extendible Implant
7. Pfizer Receives Complete Response Letter from FDA for REMOXY®
8. Amsterdam Molecular Therapeutics Receives Opinion on Glybera(R) Marketing Authorisation Application
9. Luminex Corporation Named Most Innovative Company of the Year and Receives Business Innovation of the Year Award for MAGPIX® System
10. MiMedx Group Receives FDA Clearance to Market Its HydroFix™ Ortho Shield™ Device
11. ProStrakan Receives FDA Approval for Rectiv™ for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures
Post Your Comments:
(Date:11/25/2015)...  Linden Care, LLC, a retail specialty pharmacy focused ... suffering from chronic pain, said today that it is ... (TRO) enjoining Express Scripts from unilaterally terminating the Pharmacy ... --> --> The company said that ... --> --> In ...
(Date:11/25/2015)... USA , Inc., a leader in ... accuracy of its blood glucose meter systems. Last week ... Cardiovascular Disease in Los Angeles , ... 01 meter and the Assure ® Prism multi-user ... measure glucose levels in blood is essential for people ...
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 Allergan plc ... an agreement with the New York State ... 2 of the Sherman Act, and other statutes with the ... in February 2014, to cease marketing and selling the now ... of settlement, Allergan admits no liability, has released its counterclaims ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... Consistent with the Radiology Business Management ... Radiology Marketing Programs meeting will showcase some of the best 2015 radiology ... Palace in Las Vegas with a pre-conference session on a collaborative approach for ...
(Date:11/27/2015)... ... November 27, 2015 , ... The moment you stop ... not only fulfilling the needs of advisers and clients but going above and ... providing top-tier customer service. However, there's always room for improvement, which is why ...
(Date:11/27/2015)... ... November 27, 2015 , ... The men and women ... healthcare organizations in the country. They have overseen financial turnarounds, shown commitment to ... the healthcare industry as a whole through their advocacy and professional efforts. , ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., developer and ... of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 product line. ... 5.10 up-to-date with a version of Asterisk that will receive not only security ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... system for diagnostic imaging in the Waterloo region. Using the Ocean Platform, family ... tests directly from their electronic medical record (EMR) without the need for redundant ...
Breaking Medicine News(10 mins):