Blue Medical out of Eindhoven, The Netherlands is launching to market its Protégé Drug Eluting Balloon and Pioneer CoCr stent.
The devices have the European CE Mark and offer a new clinical option of having the benefit of anti-platelet Paclitaxel during balloon angioplasty but none on the stent itself.
Blue Medical’s novel DEB therapy delivers a controlled dose of Paclitaxel to the coronary artery during balloon angioplasty. The combined device with a CoCr coronary stent delivers drugs during stent placement as a onetime shot only, instead of continuous drug delivery known from drug eluting stents. This reduces the period in which anti-platelet medication could be required significantly. Low MACE rates and low Late Lumen Loss indicating the efficacy and safety of the Protégé and Pioneer DEB Products are confirmed by the clinical data of Blue Medical’s Human Trial PIONEER.
“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 patient comfort and reducing risks for bleeding and stent thrombosis.”