Navigation Links
FDA Clears Xlumena's NAVIX(TM) Access Device
Date:4/28/2010

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
9. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
10. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
11. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/6/2017)... is Stroke Awareness Month and Omron Healthcare is reminding ... prevent a stroke: monitor and manage your blood pressure. ... undetected and uncontrolled hypertension is a leading risk factor ... personal heart health technology, recently evolved its mission to ... and is advancing a national public education effort to ...
(Date:5/4/2017)... 2017 Clarius Mobile Health, a digital ... scanners this week at the American Congress of ... San Diego, CA from ... the perfect tool for clinicians to easily confirm ... evaluate pregnancy-related complications like ectopic pregnancy and placenta ...
(Date:5/4/2017)... BOTHELL, Wash. , May 4, 2017   ... a leading developer, manufacturer and marketer of proprietary clinical ... media ("BioLife" or the "Company"), today announced that ... released after market close on Thursday, May 11, 2017, ... and live webcast at 1:30 p.m. PT that afternoon. ...
Breaking Medicine Technology:
(Date:5/23/2017)... York City (PRWEB) , ... May 23, 2017 ... ... (EHR), Population Health and Clinical Integration company, announced today that its iClinic ... Medical Home (PCMH) 2017 Prevalidation. NCQA recently introduced PCMH 2017 standards which ...
(Date:5/23/2017)... ... ... New England Journal Of Medicine Confirms Viability of Rory’s Regulations and Deems ... Foundation Calls on Health & Human Services, Tom Price to Adopt Rory’s Regulations Nationally- ... reported on a new study released on May 21, 2017 in the New England ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... By all ... underway in Sonoma County. While officials call for diligence, asking homeowners to scout for ... at potential health concerns. Along with the annoying buzz of mosquitos is the buzz ...
(Date:5/23/2017)... ... May 23, 2017 , ... Orbita’s Nathan Treloar will discuss the ... in San Francisco. Titled Connected Health and IoT: Technology Innovators and Disruption , ... by Parks Associates, a market research and consulting firm specializing in emerging consumer technology ...
(Date:5/22/2017)... ... May 22, 2017 , ... The ... the scientific development, healthcare training and clinical application of medical infrared imaging, has ... to perform medical thermal imaging services. , The first new educational offering is ...
Breaking Medicine News(10 mins):