BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

IDev Technologies, Inc. Receives FDA Clearance for Its SUPERA VERITAS(R) 6 French Stent Delivery System


11/10/2011 7:31:27 AM

WEBSTER, Texas, Nov. 10, 2011 /PRNewswire/ -- IDEV Technologies, Incorporated (IDEV), today announced the FDA has granted 510(k) clearance for the company's 6 French (6Fr) SUPERA VERITAS Transhepatic Biliary Stent System. The new lower profile system, approved for sale outside the U.S. earlier this year, is the latest enhancement to the delivery catheter utilized with the unique SUPERA stent, currently cleared in the U.S. for palliative treatment of biliary strictures produced by malignant neoplasms.

In addition to having a lower entry profile, the new 6Fr system is available in two catheter lengths, 80 cm and 120 cm, and offers even better efficiency and trackability.

"Feedback from our European customers confirms the new 6Fr system allows for improved ease of use, trackability and control of stent deployment," commented Christopher M. Owens, President and CEO of IDEV. "As the global market continues to move toward smaller delivery sizes, we believe these regulatory clearances will provide an opportunity to accelerate market expansion and adoption of our technology. We are pleased to now have this product available to our U.S. customers and patients."

Full commercial launch of the 6Fr SUPERA VERITAS Transhepatic Biliary Stent System is anticipated in January 2012.

About IDEV Technologies, Incorporated

IDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in interventional radiology, vascular surgery and cardiology. IDEV's worldwide headquarters is located in Webster, Texas and its European headquarters is located in Beuningen, The Netherlands.

The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe, Canada, Australia and Hong Kong for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).

For more information please visit www.idevmd.com.

Contact:

Donna Lucchesi


Vice President Global Marketing


IDEV Technologies, Incorporated


(281) 525-2000



SOURCE IDEV Technologies, Incorporated



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES