HELMOND, The Netherlands, March 20, 2012/PRNewswire/ –Blue Medical today announced the global product launch of its CE approved drug eluting balloon (DEB) Protégé as well as its CoCr stent on DEB Pioneer. The full market launch of the new DEB technology is a major step forward in Blue Medical’s quest to improve the quality of life of patients with cardiovascular diseases, while at the same time reducing procedure costs.
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.”
“Our extensive research effort combined with human evaluation ensures a highly reliable science based and effective DEB technology.” said Ronald Horvers, CEO of Blue Medical, “The critical and extensive review of the Dutch Medicine Evaluation Board and notified body BSI enables us to provide an attractive alternative for treating coronary disease.”
Blue Medical continues to develop their novel DEB technologies into additional applications both for coronary and peripheral application through its scientific and clinical programs.
About: Blue Medical
Located in the Dutch Brainport area, Blue Medical (http://www.bluemedical.com) is a global medical devices company and innovator in the treatment of cardiovascular and peripheral diseases. The company develops, manufactures and markets innovative medical products for vascular diseases. Every year, over 100.000 patients are treated with devices of Blue Medical in countries worldwide.
Source: Blue Medical