FDA Approves New Lengths for BD's Lutonix 018 DCB Product Line
June 3, 2019—BD (Becton, Dickinson and Company) announced that the FDA has approved expanded sizes of the company's Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery lesions in patients with peripheral artery disease. The new lengths are 80, 100, 150, and 220 mm.
According to the company, the Lutonix 018 DCB's variety of longer sizes allow more options for treating 7-mm-diameter vessels. The device is designed to perform over small guidewires, reduce guidewire exchanges, and enable alternative access sites.
Lutonix 018 DCB is available in the United States and currently undergoing the regulatory approval process in Europe, stated BD.