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:5/5/2016)... ... May 05, 2016 , ... TIME for Kids and The ... announced a new partnership to reach nearly 1 million children with important water safety ... and is the leading cause of accidental death in children one to 6 years ...
(Date:5/5/2016)... Woodinville, WA (PRWEB) , ... May 05, 2016 ... ... better user experience, adapted to people’s every day living patterns, Amerec, a Seattle-based ... easy-to-use computer and smart phone app. , The user interface of the app, ...
(Date:5/5/2016)... ... (PRWEB) May 05, 2016 , ... Talent Tech Labs ... on the eve of National Nurses Week (May 6-12). Currently, HireNurses is ... With their enrollment into the Talent Tech Lab Virtual Incubation program, they will dramatically ...
(Date:5/5/2016)... ... 2016 , ... Chronic stress can have a silent, yet dangerous, impact on ... system and increase inflammation, both of which raise the risk of heart attack and ... program at Harvard-affiliated Massachusetts General Hospital. Chronic stress also can lead to other issues ...
(Date:5/5/2016)... ... May 05, 2016 , ... ... finalists and winners Tuesday evening, May 3, at the 2016 ISE® Central Executive ... Scott Pettigrew, Vice President and Chief Security Officer of HMS, was selected as ...
Breaking Medicine News(10 mins):
(Date:5/4/2016)... 2016 Yissum Research Development ... today that it had signed an exclusive world-wide licensing ... of novel protein degradation and immunomodulatory drugs for cancer ... drug candidates representing first-in-class therapy for hematologic and solid ... The novel technology was developed by ...
(Date:5/4/2016)... May 4, 2016 ... the  "Global Acute Myeloid Leukemia Market and ... their offering.       (Logo: ... Leukemia Market and Competitive Landscape Highlights 2016, ... pipeline products, Acute Myeloid Leukemia epidemiology, Acute ...
(Date:5/3/2016)... Research and Markets has announced the addition ... Outlook 2020" report to their offering. ... has improved significantly in past years due to which ... years. Many cancer drugs have been developed by utilization ... expected to be developed with its help. They are ...
Breaking Medicine Technology: