Boston Scientific Receives CE Mark For Ranger™ Drug-Coated Balloon

Innovative Technology Strengthens Company's Leading Portfolio of Solutions for Peripheral Vascular Disease

MARLBOROUGH, Mass., -- Demonstrating its continued leadership in the development of innovative solutions for peripheral vascular disease, Boston Scientific Corporation has received CE Mark for the Ranger™ Paclitaxel-Coated PTA Balloon Catheter.  The technology is now in full European market launch.  The Ranger Drug-Coated Balloon (DCB) provides physicians with an additional option to treat peripheral artery disease, delivering an anti-stenotic drug to diseased vascular tissue while leaving no permanent implant behind.

"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," said Dierk Scheinert, M.D., director, Center of Vascular Medicine, Angiology and Vascular Surgery at Park Krankenhaus, Leipzig, Germany.  "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."

The Ranger DCB combines the deliverability of the market-leading Sterling™ balloon platform and the proven drug Paclitaxel with advanced technologies designed to address the delicate and often unstable nature of the coating associated with contemporary drug-coated balloons.  The Ranger DCB features proprietary TransPax™ coating technology and an innovative loading tool designed to maintain drug-coating integrity and maximize drug-transfer efficiency resulting in consistent and predictable drug delivery.

"Boston Scientific is a leader in the development of drug-eluting technologies, including nearly 20 years of research on the vascular use of Paclitaxel," said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific.  "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."

About Peripheral Artery Disease
Peripheral artery disease (PAD) is a circulatory disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs.  As the disease progresses, plaque accumulation may significantly reduce blood flow through the arteries, resulting in pain and increasing disability, with severe cases often leading to amputation of the affected limb.  It is estimated that 12-14 percent of the general population is affected by PAD¹.

1) Shammas NW (2007). "Epidemiology, classification, and modifiable risk factors of peripheral arterial disease." Vasc Health Risk Manag 3 (2): 229–34. doi:10.2147/vhrm.2007.3.2.229. PMC 1994028. PMID 17580733

Source: Boston Scientific