BD's Lutonix 018 DCB Approved by FDA to Treat SFA Disease
December 18, 2018—BD (Becton, Dickinson and Company) announced that it has received FDA approval for its 0.018-inch–guidewire-compatible Lutonix 018 drug-coated balloon (DCB) for the treatment of long superficial femoral artery lesions in patients with peripheral artery disease.
The Lutonix 018 DCB is now available for sale in the United States. In Europe, the device is pending CE Mark approval, advised BD.
Interventional radiologist Constantino Pena, MD, commented in the company's announcement, “By virtue of its lower profile and compatibility with smaller guidewires, the Lutonix 018 DCB will allow physicians to treat more complex lesions from more access sites without the need to exchange to an 0.035-inch guidewire. Combined with the 220-mm lengths, this represents a significant improvement in our ability to efficiently and effectively deliver a proven drug technology.”