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:2/12/2016)... 2016  This month,s issue of the Journal ... an in-depth look at various causes and consequences associated with rising ... spending, which has generated significant public outrage and calls ... Laura E. Happe , PharmD, MPH. --> ... MPH. --> In 2014 prescription drug spending ...
(Date:2/12/2016)... Pharmacy, Inc. (NYSE: DPLO ) is pleased to announce the promotion of Paul ... Jan. 23, 2016. To learn more about ... ... ... In his ...
(Date:2/12/2016)... - Demers Ambulances announces its first delivery in the state of ... Emergency Medical Services (EMS) consisting of four vehicles: ... Quality Emergency Vehicles in Lecanto, FL , ... is the latest in Demers, ongoing expansion of sales.  ... --> Benoit LaFortune , Executive Vice President at ...
Breaking Medicine Technology:
(Date:2/12/2016)... San Antonio, TX (PRWEB) , ... February 12, 2016 , ... ... of love, as expressed in Blue SKies Buddha, the biography of Rama - Dr. ... in fact a love story, the love of a Buddhist teacher for teaching and ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... 1:30 p.m. – 3:00 p.m. EST, http://www.fdanews.com/fixeddosecombination , ... of pharmaceutical products, garnering increased attention from all stakeholders in the development of ...
(Date:2/12/2016)... ... February 12, 2016 , ... The ThedaCare Center for Healthcare ... Hospital on April 5-7. The series is a multi-day, multi-workshop event designed to ... cover a broad range of topics, including coaching skills, the scientific method of ...
(Date:2/12/2016)... ... ... The Jones Agency, a family owned insurance company with offices serving Arlington, ... drive with the Tarrant Area Food Bank in the hopes of alleviating hunger for ... the Tarrant County Food Bank offers hope and security to the one in six ...
(Date:2/12/2016)... ... February 12, 2016 , ... Miami Dental Specialists is excited to bring ... dental office. Beginning in January, Miami Dental Specialists will offer the non-metal implants as ... first office to be chosen by the dental implant manufacturer, Straumann, to bring this ...
Breaking Medicine News(10 mins):