Nov. 15, 2010 - BLUE MEDICAL RECEIVES EUROPEAN CE MARK APPROVALS FOR DRUG ELUTING BALLOON AND STENT ON DRUG ELUTING BALLOON COMBINATION DEVICE - First ever CE approved combination device is an attractive treatment for coronary artery diseases - Blue Medical 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."... Blue Medical's Press Release -
