FDA Clears Xlumena's NAVIX(TM) Access Device New Access & Dilation Device for Interventional Endoscopists
MOUNTAIN VIEW, Calif., April 28 /PRNewswire/ -- Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, today announced it has received clearance from the US Food and Drug Administration (FDA) to market its NAVIX™ Access Device. The NAVIX™ Device is an advanced endoscopy system, consisting of a multi-lumen catheter with a trocar, anchor and dilation balloons and two guidewire ports, designed to enable secure access, dilation and delivery of guidewires for pseudocyst and abscess drainage procedures.
"We are pleased to introduce the NAVIX™ Access Device, the first in a line of revolutionary products under development, based on Xlumena's Advanced Translumenal Therapy™ technology," said Michael Allen, President and CEO of Xlumena. "We believe this is an important first step in providing the interventional endoscopist with innovative tools that will enable a broader reach within the specialty and take interventional endoscopy to a new therapeutic level."
Kenneth Binmoeller, M.D., Medical Director at the Interventional Endoscopy Center at California Pacific Medical Center in San Francisco, Calif. added: "Xlumena has accurately identified some of the technical challenges, the interventional endoscopists are struggling with, and is developing simple, elegant solutions with products such as the NAVIX™ Access Device.
Xlumena will initially make the NAVIX™ Access Device available to a select number of interventional endoscopy centers across the US. The clearance follows the Xlumena AXIOS™ translumenal gallbladder stent and delivery system receiving a humanitarian use designation by the FDA. FDA clearance for the AXIOS™ stent and delivery system is pending.
Xlumena will host a Tech Suite at the Digestive Diseases Week (DDW) meeting in New Orleans, LA on May 2-6, 2010 to showcase the NAVIX™ and other Advanced Translumenal Therapy™ platforms to invited partners and physicians.
About Xlumena, Inc. Based in Mountain View, Calif., Xlumena was founded in 2008 to develop, manufacture and market advanced, image-guided therapeutic endoscopy devices for the gastroenterologist/interventional endoscopist. Collaborating with top physicians in the field, Xlumena focuses on interventional innovation, the practice of listening to physicians, leveraging their expertise, and being inspired by their vision. That inspiration, along with Xlumena's design capabilities and resources, guides the development of technology that advances therapy to the next level. These innovations may enable numerous translumenal therapeutic procedures, helping transform complex surgeries into outpatient events. For more information, visit the company's web site at xlumena.com. Advanced Translumenal Therapy™, NAVIX™ and AXIOS™ are trademarks of Xlumena.
SOURCE Xlumena, Inc.