Boston Scientific announced it has received FDA approval of the Ranger drug-coated balloon, developed for the treatment of patients with peripheral artery disease.

Boston Scientific announced it has received FDA approval of the Ranger Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Approximately 200 million people around the world are affected by PAD1, a common circulatory problem in which plaque builds up and narrows arteries, consequently reducing blood flow to limbs. The Ranger DCB was designed with a low therapeutic drug dose and proprietary coating which efficiently transfers the drug into the tissue, resulting in high primary patency rates and low systemic drug exposure for patients. The low-profile platform of the balloon also assists clinicians in performing streamlined procedures and navigating through challenging anatomy in order to deliver consistent therapy. The FDA approval is based on results from the RANGER II SFA pivotal trial, which evaluated the safety and effectiveness of the Ranger DCB versus standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with PAD in the SFA and PPA. In the randomized controlled trial, both primary endpoints were met:The primary safety endpoint of 12-month freedom from major adverse events (MAE) was 94.1% for those treated with the Ranger DCB versus 83.5% for standard PTA (Pnon-inferiority <0.0001).additionally, patients who received therapy with the ranger dcb had a significantly lower target lesion revascularization rate a component of mae of 5.5 in contrast to 16.5 observed with standard pta p="0.0011)," substantially reducing a patients need for repeat procedures.the primary efficacy endpoint of 12-month binary primary patency a measure of the target vessel remaining unobstructed was 82.9 for the ranger dcb and 66.3 for standard pta p="0.0017)." primary patency by kaplan-meier estimate was 89.8 for the ranger dcb and 74.0 for pta at 12 months p="0.0005).">