BD Announces Completion of Enrollment in the Lutonix 014 DCB BTK Trial
January 18, 2018—BD Interventional announced the completion of enrollment in the Lutonix below-the-knee (BTK) trial. BD plans to submit a premarket approval application in late 2018.
According to the company, the Lutonix BTK trial is a prospective, multicenter, randomized controlled trial intended to demonstrate the superior efficacy and noninferior safety of its Lutonix 014 drug-coated balloon (DCB) as compared with standard angioplasty balloon catheters for the treatment of severe claudication and critical limb ischemia (CLI) patients with stenotic or occlusive lesions in the BTK arteries. The Lutonix BTK trial has enrolled more than 450 patients over the past 4 years.
The Lutonix 014 DCB has been commercially available in Europe, Canada, and Australia for treatment of BTK arteries associated with CLI since 2013, advised the company.