Blue Medical has received CE mark for Drug Eluting Balloon (DEB) and simultaneously for 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.
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.
Pioneer study primary investigator and Maasstad Hospital in Rotterdam, The Netherlands, Intervention Cardiology head Peter Smits said that 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, Blue Medical will introduce the CoCr stent on DEB – Pioneer, and its DEB – Protege across Europe by the end of the year.
Blue Medical CEO Ronald Horvers said that the 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.
“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,” Horvers said.