Blue Medical receives CE mark approval for drug-eluting balloon and stent on drug eluting-balloon combination device


Blue Medical announced on 16 November 2010 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, 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 patient comfort and reducing risks for bleeding and stent thrombosis.”


The CE mark approval is based on extensive in vivo research performed worldwide and preliminary data collected in the PIONEER clinical trial. 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.”