Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon.

Abstract

The Lutonix® drug coated balloon (DCB) is a combination device composed of a standard percutaneous angioplasty balloon coated with paclitaxel. Depending on the balloon size, a dose density of 2μg/mm(2) yields a variable total dose raging from 1.5mg to 3.8mg. This drug coated balloon aims to provide improved patency rates in patients with symptomatic femoropopliteal de novo or restenotic atherosclerotic disease. On June 12, 2014, the Food and Drug Administration's (FDA) Circulatory System Devices