Boston Scientific's Ranger DCB Receives CE Mark Approval

July 14, 2014—Boston Scientific Corporation announced that the company has received European CE Mark approval for the Ranger paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of peripheral artery disease. The Ranger drug-coated balloon (DCB) delivers an antistenotic drug to diseased vascular tissue while leaving no permanent implant. The technology is now in full European market launch, noted Boston Scientific.

According to the company, the Ranger DCB combines the deliverability of Boston Scientific’s Sterling balloon platform and the drug paclitaxel with technologies designed to address the delicate and often unstable nature of the coating associated with contemporary DCBs. The Ranger device features the company’s TransPax coating technology, with a loading tool designed to maintain drug-coating integrity and maximize drug-transfer efficiency, resulting in consistent and predictable drug delivery.

In Boston Scientific’s press release, Dierk Scheinert, MD, commented, “The Ranger DCB offers tremendous promise and will provide another important tool to treat both above-the-knee and below-the-knee lesions. When using contemporary technologies, a significant amount of drug coating can be lost during the handling, insertion, and delivery of the device. I am excited by the technology in the Ranger DCB, which has the potential to reduce drug loss significantly while optimizing both deliverability and the absorption of the drug in the targeted tissue.” Dr. Scheinert is director of the Center of Vascular Medicine, Angiology, and Vascular Surgery at Park Krankenhaus in Leipzig, Germany.