Blue Medical Receives CE Mark Approvals for Protégé and Pioneer Devices

November 16, 2010—Blue Medical Devices BV (Helmond, The Netherlands) announced CE Mark approval for its Protégé drug-eluting balloon (DEB) and Pioneer coronary cobalt chromium stent mounted on a DEB for the treatment of coronary artery disease. Blue Medical will introduce the devices in Europe by the end of 2010.

According to the company, the Protégé DEB delivers a controlled dose of paclitaxel to the coronary artery during balloon angioplasty. The Pioneer device provides a combination of a one-time short and precise drug delivery with a DEB and concurrent placement of a coronary stent. The CE Mark approval is based on in vivo research performed worldwide and preliminary data collected in Blue Medical's PIONEER clinical trial. Peter Smits, MD, is the primary investigator of the PIONEER study.

“Increased late stent thrombosis risk and the [use of] long-term dual-antiplatelet medication, which are associated with the majority of current drug-eluting stents, [are] a concern in treating our patients today,” commented Dr. Smits. “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-antiplatelet medication, improving patient comfort and reducing risks for bleeding and stent thrombosis.”