FDA gives drug-coated balloon a green light

The FDA approved a drug-coated balloon (DCB) as a treatment for peripheral artery disease, making it the first DCB to be approved in the U.S. for use in the superficial femoral and popliteal arteries.

The FDA’s Circulatory Systems Devices Advisory Panel had voted unanimously in favor of approval of the Lutonix DCB percutaneous transluminal angioplasty catheter earlier this year. The FDA said evaluators assessed one nonclinical and three clinical trials to evaluate the safety and effectiveness of the device.

”Peripheral artery disease can be quite serious,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a release. “Preventing further blockage of arteries is just as important as removing the initial blockage. The clinical data show that Lutonix DCB may be more effective than traditional balloon angioplasty at helping to prevent further blockage in the artery.”

The after predilatation, the Lutonix DCB percutaneous transluminal catheter can be used as treatment of de novo or restenotic lesions up to 150mm in length, according to C.R. Bard, which acquired the manufacturer Lutonix in 2011. The DCB received CE mark that year as well.