The prospective, randomized, controlled trial, comparing the Ranger DCB to uncoated PTA balloons, included 105 patients with femoropopliteal lesions, at ten centers in Europe. Results demonstrate 86 percent primary patency and 91 percent freedom from TLR; both findings statistically significantly higher than the control arm of patients treated with an uncoated balloon. Patency was assessed by duplex ultrasound at 12 months post-procedure. Eighty-four percent of patients in the Ranger DCB group presented either with no or mild symptoms associated with claudication, or pain while walking. There were no target limb amputations.
“The rates of primary patency and freedom from target lesion revascularization are amongst the highest observed in this type of first-in-man trials at one year,” said Dierk Scheinert, M.D., Chairman Division of Interventional Angiology, University Hospital Leipzig, Germany and principal investigator of the RANGER SFA trial. “As a clinician, it is important to have a treatment option, like the Ranger drug-coated balloon, that exhibits consistent performance and outcomes; for patients, these attributes impact their quality of life such as alleviating pain and discomfort, as well as reducing the probability of repeat procedures.”
To expand upon these findings, Boston Scientific recently received approval to commence enrollment in the RANGER II SFA study, a randomized Investigational Device Exemption trial designed to evaluate the safety and efficacy of the Ranger DCB versus Standard PTA Balloons. Anticipated enrollment will include up to 400 patients in 70 centers in the U.S., Canada, Europe, Japan and New Zealand. Data from the RANGER II SFA trial is expected to support regulatory submissions in the U.S. and Japan.
“As a pioneer in developing innovative devices for combatting peripheral artery disease, Boston Scientific is committed to offering a complete portfolio of drug-eluting therapies designed to revolutionize the field,” said Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. “Between our drug-coated balloon and drug-eluting stent platforms, we will study over 3,500 patients in twenty global trials and we’re looking ahead to extending therapies that provide clinicians with the tools and evidence they need to treat patients with lower-extremity arterial disease and beyond.”
The Ranger drug-coated balloon received CE Mark in June of 2014 and is an Investigational device and not available for sale in the U.S.
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.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.eu and connect on Twitter and Facebook.
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