BD (Becton, Dickinson and Company) announced the completion of enrollment in the Lutonix below-the-knee (BTK) trial and plans to submit a pre-market approval application in late 2018. The Lutonix BTK trial is a prospective, multicenter, randomized, controlled trial intended to demonstrate superior efficacy and non-inferior safety of the Lutonix 014 Drug Coated Balloon (DCB) as compared to standard angioplasty balloon catheters for treatment of severe claudication and critical limb ischemia (CLI) patients with stenotic or occlusive lesions in the below-the-knee arteries. The Lutonix BTK trial is the only on-going DCB trial for BTK arteries in the U.S. and has enrolled more than 450 patients over the past four years.