BD Receives FDA Approval for LUTONIX 018 Drug Coated Balloon
December 18, 2018 -- BD (Becton, Dickinson and Company) announced that it has received U.S. Food and Drug Administration (FDA) approval for its new LUTONIX® 018 Drug Coated Balloon (DCB), the first and only 0.018” guidewire compatible DCB approved in the United States for the treatment of long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
“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” guidewire. Combined with the 220mm lengths, this represents a significant improvement in our ability to efficiently and effectively deliver a proven drug technology,” commented interventional radiologist Constantino Pena, MD.
In a statement regarding the company’s latest announcement, Steve Williamson, Worldwide President of BD Peripheral Intervention, remarked “The LUTONIX® 018 DCB is the latest example of BD’s commitment to deliver innovative drug device technologies to patients and physicians to aid in the fight against PAD. After launching the first DCB indicated for use in the SFA and AV circuit, as well as completing the first positive trial of a DCB below the knee, launching the first 018 DCB in the US is a natural addition to BD’s growing portfolio of drug delivery technologies.”
The LUTONIX® 018 DCB is now available for sale in the United States and pending CE mark approval.