First Combination Stent on Drug-Eluting Balloon Cleared in Europe
November 17, 2010 – A drug-eluting balloon (DEB) and a coronary stent have received CE mark approval in Europe. The DEB and the coronary CoCr stent, both by Blue Medical, have been approved for treating coronary diseases.
DEB therapy delivers a controlled dose of Paclitaxel to the coronary artery during balloon angioplasty.
"Increased late stent thrombosis risk and the long term dual antiplatelet medication which are associated with the majority of current drug eluting stents is a concern in treating our patients today," said Peter Smits, M.D., head of intervention cardiology at the Maasstad Hospital, Rotterdam, the Netherlands and primary investigator of the PIONEER Study. "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."
Based on the CE mark, the company 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."
For more information: www.bluemedical.com
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