Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for its Ranger drug-eluting balloon for treating peripheral artery disease.
Marlborough, Mass.-based Boston Scientific said the paclitaxel-coated Ranger balloon is designed to be used during percutaneous transluminal angioplasty to deliver the anti-stenotic drug without leaving behind a permanent implant. The Ranger device is in "full European market launch," according to a press release.
"Boston Scientific is a leader in the development of drug-eluting technologies, including nearly 20 years of research on the vascular use of paclitaxel," peripheral interventions president Jeff Mirviss said in prepared remarks. "This latest innovation in drug and coating technology is another example of our commitment to advancing the care of patients worldwide. We are pleased to add a state-of-the-art drug-coated balloon to our leading portfolio of peripheral solutions."
The Ranger device, based on Boston Scientific’s Sterling balloon platform, uses the company’s TransPax coating and new technology designed to "address the delicate and often unstable nature of the coating associated with contemporary drug-coated balloons," according to the release.
"The Ranger drug-coated balloon offers tremendous promise and will provide another important tool to treat both above-the-knee and below-the-knee lesions," Dr. Dierk Scheinert of the Center of Vascular Medicine, Angiology and Vascular Surgery in Leipzig, Germany, said in a statement. "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 drug-coated balloon, which has the potential to reduce drug loss significantly while optimizing both deliverability and the absorption of the drug in the targeted tissue."