Navigation Links
XTENT Receives CE Mark Approval for CUSTOM NX (R) Drug-Eluting Stent System
Date:3/19/2009

60 millimeter Custom NX 60 is the world's longest coronary stent to ever be approved

MENLO PARK, Calif., March 19 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced that it has received CE Mark approval for its CUSTOM NX drug-eluting stent (DES) System. The CE Mark indicates that the CUSTOM NX DES System may be marketed in the European Union as well as other countries that recognize the CE Mark and that the product complies with applicable safety and quality standards. The approval includes both the Custom NX 36, a 36 millimeter stent and the Custom NX 60, a 60 millimeter stent.

"Receipt of the CE Mark is an important accomplishment and a validation of the strength of our clinical data," stated Gregory D. Casciaro, President and Chief Executive Officer of XTENT. "It is a tribute to the hard work and dedication of our people as well as the collaborative effort of our drug coating provider, Biosensors. We look forward to the opportunity to bring this revolutionary new technology to patients and physicians throughout the European Union."

The CE Mark approval of the Custom NX DES System represents a number of important firsts in the treatment of coronary artery disease including:

  • Approval of the first ever customizable stent system
  • Approval of the Custom NX 60, the longest coronary stent system ever to be approved for sale
  • Approval of the first stent system to allow treatment of multiple lesions using one catheter
  • Approval of the first stent system to incorporate a post dilation feature on the delivery catheter

About the Custom NX(R) Drug Eluting Stent System

The Custom NX DES System is designed to enable a more personalized approach to the treatment of arterial disease based on each patient's individual lesion characteristics. The Custom NX delivery system allows physicians to customize the length and diameter of the stent at the site of the lesion. Two sizes of the system have been developed, the Custom NX 36, a 36 millimeter stent and the Custom NX 60, a 60 millimeter stent. The stent is coated with Biolimus A9TM and the biodegradable drug carrier, PLA. XTENT has completed four clinical trials with follow-up data up to four years.

The Custom NX DES System has not been approved for sale in the United States.

About XTENT

XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent (DES) systems for the treatment of coronary artery disease (CAD). CAD is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. XTENT Custom NX DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding XTENT's business that are not historical facts may be "forward-looking statements" that involve risks and uncertainties. Specifically, these statements include, but are not limited to those concerning: XTENT's expectations with respect to the timing of the commercialization of its products in the European Union or elsewhere. Forward-looking statements are based on management's current, preliminary expectations, and are subject to risks and uncertainties that could cause actual results to differ from the results predicted and which are included in the "Risk Factors" section of XTENT's quarterly report on Form 10-Q for the quarter ended September 30, 2008. This quarterly report was filed with the SEC on November 12, 2008, and is available on the company's investor relations website at http://www.xtentinc.com and on the SEC's website at http://www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. XTENT undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.


'/>"/>
SOURCE XTENT, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. XTENT Announces Fourth Quarter 2008 Financial Results and Business Progress
2. APIC Covers Up Extent and Causes of Deadly C. diff
3. XTENT Announces Third Quarter 2008 Financial Results
4. XTENT Announces Second Quarter 2008 Financial Results and Business Progress
5. XTENT Appoints Christopher M. Smith and Arthur T. Taylor to Board of Directors
6. XTENT Announces CUSTOM I Data Receives Recognition from EuroIntervention
7. XTENT to Present at Cowen and Companys 28th Annual Health Care Conference
8. XTENT Announces 2007 Financial Results
9. New study shows extent of harmful human influences on global ecosystems
10. XTENT Announces 2007 Financial Results Conference Call
11. XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ... ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate professor Janice ... of cardiovascular diseases during the 15th Annual Women’s Health Conference. The SIU ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of ... Philippines. “The Journey: From the Mountains to the Mission Field” is the creation of ... taught all ages and currently teaches a class of ladies at her church, which ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has ... today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula ... the highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... Hair Restoration, has recently contributed a medical article to the newly revamped ... Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global digital ... its MyDario product is expected to appear on The Dr. Oz Show ... Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked off ... The segment features ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical ... device is now successfully helping those with the widespread ... Fibromyalgia diagnosed Amanda in Essex, England ... and washing my hair, experiencing no sleep at all, ... painful spasm… I cannot recommend [the AVACEN 100] enough, ...
(Date:9/13/2017)... OrthoAtlanta has been named the official orthopedic and sports ... the 2018 College Football Playoff (CFP) National Championship to be ... Atlanta, Georgia . OrthoAtlanta is proud to ... in many activities leading up to, and including the national ... OrthoAtlanta ...
Breaking Medicine Technology: