Boston Scientific (NYSE:BSX) today said it received FDA approval for its Ranger drug-coated balloon for peripheral artery disease.
The balloon’s creators designed it to treat peripheral artery disease (PAD) in the superficial femoral artery and proximal popliteal artery — with a low therapeutic drug dose and coating to transfer the drug into the tissue.
“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 news release.
“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,” Mirviss said.
The Ranger balloon features a low-profile platform to help clinicians perform streamlined procedures and navigate through challenging anatomy to deliver consistent therapy.
“The Ranger DCB eases deliverability for a wide range of lesion complexities via a low profile platform that is compatible with smaller diameter guidewires and has shown consistent results in multiple randomized controlled trials,” said Dr. Ravish Sachar, the physician-in-chief for heart and vascular services at UNC Rex Hospital. “For physicians seeking to limit systemic drug loss without compromising outcomes, data demonstrate the Ranger DCB is a safe and effective treatment option.”
