Navigation Links
Blue Medical Receives European CE Mark Approvals for Drug Eluting Balloon and Stent on Drug Eluting Balloon Combination Device
Date:11/16/2010

Blue Medical Receives European CE Mark Approvals for Drug Eluting Balloon... -- HELMOND, The Netherlands, November 16, 2010 /PRNewswire/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Biotechnology, Health Care & Hospitals, Medical Equipment, Medical Pharmaceuticals, Awards, Licensing Click to view news release full screen  

Blue Medical Receives European CE Mark Approvals for Drug Eluting Balloon and Stent on Drug Eluting Balloon Combination Device

 

HELMOND, The Netherlands, November 16, 2010 /PRNewswire/ --

- First Ever CE Approved Combination Device is an Attractive Treatment for Coronary Artery Diseases

Blue Medical today announced that the company received CE Mark approval for Blue Medical science based Drug Eluting Balloon (DEB) and simultaneously for Blue Medical's coronary CoCr stent mounted on a Drug Eluting Balloon (CoCr Stent on DEB) in Europe for treatment of coronary diseases.

DEB therapy delivers a controlled dose of Paclitaxel to the coronary artery during balloon angioplasty. A unique combination of a one-time short and precise drug delivery with DEB during placement of a coronary stent is now for the first time approved and available in Europe.

"Increased late stent thrombosis risk and the long term dual anti-platelet medication which are associated with the majority of current drug eluting stents is a concern in treating our patients today," said Primary Investigator of the PIONEER Study Peter Smits, M.D., head of Intervention Cardiology at the Maasstad Hospital, Rotterdam, The Netherlands. "DEB therapy in combination with bare metal coronary stents offers a potential solution for reducing late lumen loss without the need for long term dual-anti-platelet medication, improving patent comfort and reducing risks for bleeding and stent thrombosis."

The CE Mark approval is based on extensive in-vivo research performed world-wide and preliminary data collected in Blue Medical's clinical trial, PIONEER. Based on the CE mark, Blue Medical will introduce the CoCr stent on DEB, called Pioneer and its DEB, called Protege across Europe by the end of the year.

"This CE Mark is the first approval by a regulatory agency for the use of DEB therapy in combination with a bare metal stent and provides a new attractive treatment for patients in Europe who are in need of other options," said Ronald Horvers, CEO of Blue Medical. "We worked closely with the respected Dutch competent authority CBG and with KEMA as notified body to ensure a solid science base for this CE approval."

About Blue Medical

Blue Medical (http://www.bluemedical.com), headquartered in Helmond, The Netherlands, is a global medical devices company and innovator in treatment of cardiovascular diseases. The company develops, manufactures and markets innovative products for vascular diseases extending life for over 75,000 patients worldwide annually.


'/>"/>
SOURCE Blue Medical Devices BV
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
2. You May Have a Thyroid Problem and Not Know It - Particularly If Youre Over 60, Says a New Harvard Medical School Report
3. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
4. Globus Medical Raises $110 Million in Series E Financing Round
5. Quark Pharmaceuticals Appoints New Chief Medical Officer
6. Boston University Biomedical Engineers Find Chink in Bacterias Armor
7. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
8. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
9. Flexible Medical Systems Raises $1.2M Seed Investment for Initial Human Trials
10. Cleveland Clinic Summits to Focus on Cardiovascular Medical Innovation
11. Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... March 23, 2017  Cornerstone Pharmaceuticals, Inc., ... major milestone today.  Following successful End-of-Phase I ... Food and Drug Administration (FDA), the Company ... regulatory path forward to conduct pivotal trials ... with acute myeloid leukemia (AML) and pancreatic ...
(Date:3/23/2017)... 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a ... that it has acquired Agalimmune Ltd., a private UK-based company ... a $6 million upfront payment, of which $3 million is ... payments may be made based on development and commercial milestones. ... Agalimmune,s ...
(Date:3/23/2017)... , March 23, 2017 AbbVie, a global ... Award-winning choreographer Julianne Hough is helping to ... in the Know about ME in EndoMEtriosis . " ... inspiring women to learn about and understand endometriosis, a ... and to address their symptoms with a healthcare ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... ChenMed, a privately owned ... of the strategic executive team expansion needed to further optimize growth and performance. ... team,” says Christopher Chen, MD, ChenMed Chief Executive Officer. “George Wheeler and ...
(Date:3/23/2017)... ... , ... Inflow IQ & Inflownomics of Raleigh, NC introduce a powerful information ... As experts in dangerous situations the Inflow IQ team can help people. ... fresh, clean & refreshing knowledge systems that enhance life. , Authentically enjoy ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... awarded Task Force Dagger Foundation the US Special Operations Command’s Patriot Award. The ... presentation, General Thomas thanked Task Force Dagger Foundation for its significant and enduring ...
(Date:3/23/2017)... ... March 23, 2017 , ... “Beyond and Back”: a true-life testimony of ... creation of published author Bonetta Rose, a wife, mother and grandmother committed to sharing ... Christian Faith Publishing, Bonetta Rose‘s new book presents actual events in the life of ...
(Date:3/23/2017)... ... March 23, 2017 , ... “The Trainer”: an electrifying ... author, Scotty, a fiction writer with an active imagination and an enthusiasm for action ... follows the tale of Wild Bill Hart, who sat looking at the thirty-three notches ...
Breaking Medicine News(10 mins):