Navigation Links
XTENT Announces European Regulatory Update
Date:6/12/2008

MENLO PARK, Calif., June 12 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced a progress update regarding its application to the designated European Notified Body for CE Mark approval of its Custom NX(R) DES System. XTENT's European Notified Body confirmed that recently presented six-month follow up results from the CUSTOM III study will be incorporated by the Drug Agency, which reviews the drug formulation submission of XTENT's CE Mark application, into its current review cycle. XTENT's CE Mark application, which included two components, the XTENT design dossier and the drug formulation submission, was filed in December 2007.

"Given the positive results of CUSTOM III, we are encouraged that the Drug Agency, which has already approved Biolimus A9(R) and PLA combinations on two other DES platforms, has accepted the additional data for review. This, we believe strengthens an already robust submission for our Custom NX System," said Gregory D. Casciaro, XTENT's President and CEO. The company anticipates a response from its European Notified Body regarding its CE Mark application this summer.

About the Custom NX(R) DES System

Custom NX 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 system allows physicians to customize the length and diameter of the stent at the site of the lesion. The system features a proprietary modular stent design that consists of multiple 6 mm cobalt chromium segments coated with Biolimus A9(R) and PLA, a biodegradable drug carrier. The Custom NX delivery system enables the stent length to be adjusted in 6mm increments and allows for the placement of up to 60mm of sten
'/>"/>

SOURCE XTENT, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Legacy Good Samaritan Hospital Surgeons Find BSGI Effective in Determining Extent of Breast Cancer in Patients With Known Diagnosis
2. XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting
3. XTENT Announces Clinical Trial Data to be Presented at Annual EuroPCR Meeting Next Week
4. XTENT Announces First Quarter 2008 Financial Results
5. Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis
6. XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
7. XTENT to Present CUSTOM I and CUSTOM II Trial Data at TCT 2007
8. PTC Therapeutics Announces Data from Additional Clinical Studies of PTC124 in Cystic Fibrosis Confirming Activity
9. Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
10. Cardiogenesis Announces Preliminary Clinical Results With the PHOENIX System Combining TMR + Stem Cells
11. Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ( http://www.researchandmarkets.com/research/6k27gw/dental ... Consumables Market - Global Industry Analysis, Size, Share, Growth, ... their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ... are used on patients in order to treat dental ...
(Date:1/15/2014)... 2014 Massachusetts General Hospital (MGH), the Broad ... announced today that they have launched a strategic ... targets and develop novel therapies for inflammatory bowel ... worldwide. The MGH-Broad-Amgen collaboration brings together scientists with ...
(Date:1/15/2014)... an unprecedented effort to curb the spread of "superbugs" such as ... an advanced and portable UV germicidal lamp manufactured by MRSA-UV is ... In order to prevent EMS paramedics and transport patients ... Palm Beach Fire Rescue is the first in the ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4Superbugs No Longer Ride In Rescue Vehicles 2
... Inc. (NYSE Amex: ANX ) today announced that ... at the 10th Annual BIOInvestor Forum Conference on Wednesday, October ... Cliff Salon at the Palace Hotel in San Francisco. ... and slide presentation on the ADVENTRX Pharmaceuticals web site at ...
... Innocoll, Inc. announced it has entered into a ... for CollaGUARD surgical adhesion barrier for the prevention of ... Dr. Michael Myers, President and CEO stated "This ... an increasingly important and dynamic market for medical products ...
Cached Medicine Technology:Innocoll Enters Partnership With Pioneer Pharma in China for the Distribution of CollaGUARD 2Innocoll Enters Partnership With Pioneer Pharma in China for the Distribution of CollaGUARD 3
(Date:4/17/2014)... IL, April 17, 2014-- Colic affects about one in ... for numerous pediatric visits during the first several months ... colic symptoms was showing promise; however, the April 1, ... (BMJ2014;348:g2107; Sung, Valerie) reported on a study, "Probiotics and ... L reuteri for infant colic did ...
(Date:4/17/2014)... from Boston University School of Medicine (BUSM) have ... consumption in an experimental model. The findings, reported ... Alcohol Abuse , may lead to more effective ... is one of the leading causes of illness ... negative economic impact by limiting the productivity of ...
(Date:4/17/2014)... (SACRAMENTO, Calif.) An international team led by researchers ... protein complex, which plays a key role in cell ... process. This is the first time the complex has ... could make cyclin B1/Cdk1 an excellent target to control ... medicine. The research was published online today in the ...
(Date:4/17/2014)... An international research team led by Cesar A. Arias, ... Center at Houston (UTHealth) has identified a new superbug ... The report appeared in the April 17 issue of ... The new superbug is part of a class of ... or MRSA, which is a major cause of hospital ...
(Date:4/17/2014)... to find a colored ribbon representing a disease. A pink ... color ribbon does one think of with lung cancer?, Although ... suffering from the disease, black may be the only one ... lung cancer patients, primarily smokers between the ages of 51 ... stigma often felt by these patients, the emotional toll it ...
Breaking Medicine News(10 mins):Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2Health News:BUSM researchers find anti-seizure drug may reduce alcohol consumption 2Health News:Dual role: Key cell division proteins also power up mitochondria 2Health News:New MRSA superbug emerges in Brazil 2Health News:Unraveling the 'black ribbon' around lung cancer 2
... news service, along,with its production and distribution partner, NewsProNet, ... to give viewers a daily update on the,latest medical ... Each weekday starting in January 2009, HealthDay TV ... Medical Officer Dr. Cynthia,Haines, who will give insight into ...
... (ECMO) Center at University Hospitals Rainbow Babies & ... Support Award from the Extracorporeal Life Support Organization ... centers offering ECMO for support of failing organ ... award recognizes centers demonstrating an exceptional commitment to ...
... Dec. 2 New research that delivers a,wealth of ... and,manufacturing is now available in the Best Practice Database, ... Best Practices,LLC. , ... these,pharmaceutical-focused studies, go to a landing page with links ...
... Cantel Medical Corp. (NYSE: CMN ) will hold ... first quarter ended October 31, 2008 on December 5, 2008 ... be Charles M. Diker, Chairman; Andrew A. Krakauer, President; Craig ... Malkin, President of Minntech Corporation. Minntech is a Cantel subsidiary. ...
... 2 Ingenious Med (IM) welcomes new CEO, S.,Hart ... solutions, with an extensive background as a leader in ... , Founder and ... the company,s success and development in all sectors, as ...
... it in first 3 months more likely to have respiratory ... mothers take folic acid (folate) during early pregnancy may have ... study. , Folate is recommended to reduce the risk of ... acid. , The researchers examined data on more than 32,000 ...
Cached Medicine News:Health News:HealthDay TV Launches 2Health News:HealthDay TV Launches 3Health News:Best Practice Database Adds Research Highlighting Effective Tactics of Sales Force and Manufacturing Groups in the Pharmaceutical Industry 2Health News:Cantel Medical Corp. to Hold Conference Call to Discuss Results for Its First Quarter Ended October 31, 2008 2Health News:Ingenious Med Hires New CEO to Maintain and Further Expand Company Development 2Health News:Folate in Early Pregnancy May Boost Wheezing in Baby 2
... intra-operative MR system is ... tool for radiologists and ... of the system is ... adjunct to standard neurosurgical ...
... Adhesive (Bioglue) is a two-component surgical ... albumin (BSA) and glutaraldehyde. The BSA ... bovine spongiform encephalopathy (BSE) free countries ... inactivates viruses. The solutions are dispensed ...
Avitene Microfibrillar Collagen Hemostat (MCH) is used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical...
... Prodisc design is based upon the ... natural spinal motion segment unit. Kinematics ... integrates the biomechanical and anatomical aspects ... concept: Three implant components utilizing proven ...
Medicine Products: