Boston Scientific announced Monday, Nov. 2, that its Ranger drug-coated balloon (DCB) for peripheral artery disease (PAD) has received FDA approval.
The Ranger DCB was designed for the treatment of patients with PAD in the superficial femoral artery and proximal popliteal artery. The approval comes after the RANGER II SFA clinical trial found that the solution was associated with fewer major adverse events compared to standard percutaneous transluminal angioplasty.
“This approval allows us to bring more treatment options with exceptional outcomes and proven safety to U.S. physicians and their patients who are facing this challenging disease,” Jeff Mirviss, president of peripheral interventions at Boston Scientific, said in a statement. “Adding the Ranger DCB to our drug-eluting portfolio, which also includes our Eluvia Drug-Eluting Vascular Stent System, reinforces our commitment to providing differentiated technology with strong clinical evidence that supports data-driven treatment decisions for millions of patients suffering from PAD worldwide.”
“For physicians seeking to limit systemic drug loss without compromising outcomes, data demonstrate the Ranger DCB is a safe and effective treatment option,” added cardiologist Ravish Sachar, MD, principal investigator of the RANGER II SFA trial.
Boston Scientific plans to immediately launch the Ranger DCB in the United States. It received CE Mark approval back in 2014.