FDA Clears Xlumena’s
NAVIX™ Access Device
New Access & Dilation Device for
Interventional Endoscopists
Mountain view,
ca., april 28, 2010
Xlumena Inc., 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
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 have a Tech Suite at the Digestive Diseases Week
(DDW) meeting in New Orleans, LA on May 2-6, 2010 and will
be showcasing 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. NAVIX and AXIOS are registered trademarks
of Xlumena.
.
About Charter Life Sciences
Charter Life Sciences (“CLS”) is a life sciences venture capital
firm with offices in Palo Alto, California and Cincinnati, Ohio. CLS focuses
on providing the initial venture capital to companies that are developing innovative
products for significant unmet medical needs. The CLS team draws on its extensive
medical, operational and start-up company experience to work collaboratively
with its portfolio companies to develop their clinical, operational and financing
strategies. For additional information on CLS, please visit www.clsvc.com.
CONTACT:
Ted Rossman/Lisa Kelaita
New Venture Communications
(650) 343-2735
trossman@newventurecom.com
lkelaita@newventurecom.com
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