Twelve-Month Data Presented for Boston Scientific's Ranger DCB in Femoropopliteal Arteries

April 25, 2017—Boston Scientific Corporation announced results from the RANGER-SFA trial at the 2017 Charing Cross Symposium in London United Kingdom. The trial is evaluating the company's Ranger paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon and demonstrated that the device resulted in high rates of primary patency and freedom from target lesion revascularization (TLR) at 12 months, reducing the need for reinterventions to re-establish flow in previously blocked blood vessels.

The prospective randomized controlled trial, which compared the Ranger DCB to uncoated PTA balloons, was composed of 105 patients with femoropopliteal lesions enrolled at 10 centers in Europe. The results demonstrated 86% primary patency and 91% freedom from TLR—both findings were statistically significantly higher than the control arm of patients treated with an uncoated balloon. Patency was assessed by duplex ultrasound at 12 months postprocedure.

The company noted that 84% of patients in the Ranger DCB group presented with either no or mild symptoms associated with claudication or pain while walking. There were no target limb amputations.

In Boston Scientific's press release, RANGER-SFA Principal Investigator Dierk Scheinert, MD, commented, “The rates of primary patency and freedom from TLR are amongst the highest observed in this type of first-in-man trials at 1 year. As a clinician, it is important to have a treatment option, like the Ranger DCB, 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 on 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 at 70 centers in the United States, Canada, Europe, Japan, and New Zealand. Data from the RANGER II SFA trial is expected to support regulatory submissions in the United States and Japan. 

The Ranger DCB received European CE Mark approval in June 2014. It is an investigational device and not available for sale in the United States, advised Boston Scientific.