CE Mark Approved for Boston Scientific's Agent PTCA Balloon

July 23, 2014—Boston Scientific Corporation announced the CE Mark approval and European launch of the Agent paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter to treat both in-stent restenosis and de novo small vessel coronary disease. The device is not available for sale in the United States, advised the company.

According to Boston Scientific, the Agent drug-coated balloon (DCB) combines the deliverability of the Boston Scientific Emerge balloon platform and the proven drug paclitaxel. The Agent DCB also features the company’s TransPax coating technology, which combines paclitaxel and a citrate ester excipient designed to maintain drug-coating integrity and maximize drug-transfer efficiency for consistent and predictable drug delivery.