FDA approves new drug-coated balloon for PAD
Boston Scientific announced the FDA has approved the Ranger drug-coated balloon for the treatment peripheral artery disease in the superficial femoral artery and proximal popliteal artery.
The Ranger drug-coated balloon was designed with a low therapeutic drug dose and proprietary coating to efficiently transfer the drug into the tissue, resulting in high primary patency rates and low systemic drug exposure for patients, according to a press release issued by Boston Scientific.
"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," Ravish Sachar, MD, Rex Hospital physician-in-chief for heart and vascular services at the University of North Carolina and principal investigator of the RANGER II SFA trial, said in the release. "For physicians seeking to limit systemic drug loss without compromising outcomes, data demonstrate the Ranger DCB is a safe and effective treatment option."
FDA approval was based on results of the RANGER II SFA randomized controlled trial, which evaluated safety and effectiveness of the Ranger DCB compared with percutaneous transluminal angioplasty for the treatment of PAD in the superficial femoral artery and proximal popliteal artery. Both primary endpoints were met. Healio previously reported the results.
"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 the 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."
Boston Scientific plans to initiate a registry of the Ranger DCB and the Eluvia stent in the coming months to gather additional real-world evidence, according to the release.
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