FDA Approves 220-mm Length of BD's Lutonix 035 DCB
September 7, 2018—BD (Becton, Dickinson and Company) announced that is has received FDA approval for the 220-mm length of its Lutonix 035 drug-coated balloon (DCB) for the treatment of long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
“The new longer lengths of the Lutonix 035 DCB represent a tremendous opportunity for physicians to enhance their PAD treatment in long lesions with a proven technology that will now require fewer DCBs and fewer inflations, reducing DCB healthcare expenditures overall,” commented vascular surgeon Chad Laurich, MD, in the company's announcement.
BD noted that in the Lutonix Global SFA Real-World Registry, 22% of the femoropopliteal lesions were longer than 150 mm. In some of these patients, multiple DCBs were used to cover the length of the long lesion. With the approval of the 220-mm device, more disease can be treated with a single Lutonix 035 DCB.