Navigation Links
XTENT Submits CE Mark Registration to Market Custom NX(R) Drug-Eluting Stent System in Europe
Date:12/27/2007

- Company continues U.S. pivotal trial discussions with FDA -

MENLO PARK, Calif., Dec. 27 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT), the developer of customizable drug-eluting stent (DES) systems, today announced that it has submitted its application to the designated European Notified Body for CE Mark approval of its Custom NX DES System.

XTENT's CE Mark application includes the XTENT design dossier and the drug formulation submission from Biosensors International Group. XTENT plans to begin European sales of the Custom NX system in the second half of 2008 through partnerships with leading regional distributors, following CE Mark approval.

"Completing our CE Mark filing is a major milestone toward achieving our goal of commercializing the Custom NX system in select European countries," said Gregory D. Casciaro, President and CEO of XTENT. "This submission further demonstrates Biosensors' commitment to the success of Biolimus A9(R) and the ongoing collaboration between the two companies."

XTENT is also continuing its work with the U.S. Food and Drug Administration (FDA) to fulfill the necessary requirements to gain approval to start the CUSTOM IV pivotal trial. The company filed an Investigational Device Exemption (IDE) in September. XTENT and Biosensors are in the process of responding to questions from the FDA. XTENT will provide an update as to the anticipated start of the CUSTOM IV trial once both companies have completed discussions with the FDA.

About the Custom NX 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 custom
'/>"/>

SOURCE XTENT, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. XTENT Announces Third Quarter 2007 Financial Results
2. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
3. Global Med Technologies(R), Inc. Submits ElDorado Donor(TM) to FDA
4. Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate
5. SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cMET Inhibitor
6. ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)
7. Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma
8. ImaRx Therapeutics Submits Urokinase Data to FDA Supporting Extended Expiration Dating
9. Glades General Hospital First in Palm Beach County to Provide On-Site Electronic Birth Registration
10. MedCom USAs Subsidiary Card Activation Technologies, Inc.s SB2 Registration Declared Effective by SEC
11. Gentiva(R) Health Services Files Universal Shelf Registration Statement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/21/2014)... “Cluster headaches are sometimes called ‘Suicide Headaches’ because ... said Steve Young of Ew Publishing; “I’ve had cluster ... is more intense.” , “It should be a relief ... that medical research is pointing to some relief and ... Serotonin (5-HT, 5-hydroxytryptamine) is a ubiquitous biochemical found in ...
(Date:9/21/2014)... Mills, Md. (PRWEB) September 21, 2014 Faculty ... school with a coed preschool in Owings Mills, Md., kicked ... wellness with Garmin Vivofit bands. GFS is the first independent ... steps taken, calories burned and even sleep patterns— as part ... a Baltimore area running and walking specialty chain. The Vivofit ...
(Date:9/21/2014)... Top10BestSEOHosting.com, a leading review website, has recently announced ... most recommended hosting suppliers for the webmasters worldwide ... , “Don’t waste your time on searching ... hosting companies to you,” the IT manager of ... are the most recommended suppliers for everyone. A ...
(Date:9/20/2014)... Las Vegas, NV (PRWEB) September 21, 2014 ... created by Dr. Kenneth Pullman that is helping thousands ... reverse their diabetes symptoms without shots, pills, or prescriptions ... investigative review. , “There are currently tens of ... with both Type 1 and Type 2 diabetes, and ...
(Date:9/20/2014)... September 20, 2014 David Cooke presented ... The first poster looked at the clinical benefits of ... for calculating diastolic function. In conjunction with colleagues at ... disease and normal LVEF by echo (>50%). Each patient ... and standard SPECT. Emory Toolbox 4.0 was ...
Breaking Medicine News(10 mins):Health News:Homeostasis: Equinox Serotonin (5HT) Headache Stories ~ New on the Bryan William Brickner Blog 2Health News:Garrison Forest School Leader in Independent School Wellness Programs 2Health News:Leading Review Website Top10BestSEOHosting.com Unveils The Best Hosting Suppliers In September 2Health News:Diabetes Protocol: Review Exposes Kenneth Pullman’s Breakthrough Discovery About Diabetes Management 2Health News:Versatility of Emory Toolbox 4.0 Shown at ASNC in Scientific Posters 2Health News:Versatility of Emory Toolbox 4.0 Shown at ASNC in Scientific Posters 3
... Medco Health,Solutions, Inc. (NYSE: MHS ) is ... On Monday, March 17, 2008, Timothy C. Wentworth, ... Medco,s specialty pharmacy,subsidiary, is scheduled to address the 28th ... the Boston Marriott Copley,Place will begin at 1:45 p.m. ...
... may not be getting them, study says , , MONDAY, March ... dictate treatment choices for kidney cancer more than clinical factors ... new study finds. , This means many patients who ... partial nephrectomy where only part of the kidney is removed, ...
... A novel drug that fully eliminated brain tumors from ... darker sidecausing permanent bone damage in younger mice. The ... finding raises concerns about using similar drugs to treat ... thorough understanding of possible risks. , Tom Curran, Ph.D., ...
... for osteoporosis or who do not respond to treatment ... affects their quality of life. There is an ... address their issues when new therapies are assessed and ... Professor Cyrus Cooper from the MRC Epidemiology Resource Centre, ...
... Inc. (Nasdaq: PBIO ) today announced that ... Avenue in South Easton, Massachusetts. This,move was necessary ... and development company to a fully commercial,operation. Richard ... now have approximately 5,500 square feet, with sufficient,office, ...
... Gentiva Health,Services, Inc. (Nasdaq: GTIV ), the ... that it is scheduled to,present from 8:30 a.m. to ... Brothers Eleventh Annual Global Healthcare Conference in Miami,Florida., ... a live audio web cast,which may be accessed by ...
Cached Medicine News:Health News:Medco to Present at Cowen and Company and Lehman Brothers Health Care Conferences 2Health News:Surgeon's Preferences Dictate Choice of Kidney Cancer Surgery 2Health News:Surgeon's Preferences Dictate Choice of Kidney Cancer Surgery 3Health News:Potential brain cancer drug for children may damage bones 2Health News:Potential brain cancer drug for children may damage bones 3Health News:Make or break time for osteoporosis treatment 2Health News:Pressure BioSciences, Inc. Announces Move to New Corporate Offices 2Health News:Gentiva(R) Health Services to Present March 18th at Lehman Brothers Eleventh Annual Global Healthcare Conference in Miami 2Health News:Gentiva(R) Health Services to Present March 18th at Lehman Brothers Eleventh Annual Global Healthcare Conference in Miami 3
(Date:9/19/2014)... 19, 2014  Alere Inc. (NYSE: ALR ... following statement today in support of President Barack ... "As the global leader in rapid diagnostics for infectious ... strategy to address the serious threat of antibiotic resistance. ... Administration on initiatives to promote the development of rapid ...
(Date:9/19/2014)... LONDON , September 19, 2014 ... hat Pharma IQ den äußerst erfolgreichen Serialisierungs-Countdown-Kalender aktualisiert, ... abdeckt. Die interaktive PDF, verfügbar unter pharmaserialisation.com ... an dem sie jeweils in Kraft treten. ... der Serialisierung nicht länger um das "ob", sondern ...
(Date:9/19/2014)... Reductions in kidney failure obtained ... people with diabetes type 2 "Intensive treatment ... the kidneys." Australian researchers have discovered that ... leads to persistent reductions in kidney failure many years ... study has found that, five and a half years ...
Breaking Medicine Technology:Alere Applauds President's Executive Order Combating Antibiotic-Resistant Bacteria 2Pharma IQ stellt weltweite Serialisierungsfristen in seinen Countdown-Kalender 2014 - 2018 2ADVANCE-ON Post-trial Observational Study: Blood Pressure Arm and Glucose Arm Results 2ADVANCE-ON Post-trial Observational Study: Blood Pressure Arm and Glucose Arm Results 3
... Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John ... Watch the Video "Congratulations ... campaign trail to earn the trust and votes of the American ... the state of our economy and jobs. "There ...
... HOPKINTON, Mass., Nov. 3, 2010 ... ), a leading provider of tools and services ... announced a collaboration with Sony DADC Austria AG ... for Caliper,s next generation microfluidics products. The agreement ...
Cached Medicine Technology:PhRMA CEO John Castellani Responds to Mid-Term Election, Stresses Importance of Innovation to Help Grow Economy 2PhRMA CEO John Castellani Responds to Mid-Term Election, Stresses Importance of Innovation to Help Grow Economy 3Caliper Life Sciences and Sony DADC Collaborate to Develop Plastic Microfluidic Solutions 2
The Electric H-Base Table is for heavier instruments, or for those who prefer electric elevation. The electric table easily accepts a slit lamp, a single tabletop, or a double tabletop, just as the M...
The Manual Table Base is elevated with an easy to reach elevating wheel for smooth operation. The table base will accept a slit lamp, a single table top, or a double tabletop for more than one instru...
A new, innovative design compliments the proven, 30-year mechanical operating system....
The Encore Stand combines the proven mechanical structure and durability of the popular Deluxe Stand, with a modern, sophisticated appearance....
Medicine Products: