BD announces completion of enrolment in Lutonix 014 DCB below-the-knee trial

Lutonix DCB

Enrolment is complete in the Lutonix below-the-knee trial with BD planning to submit a pre-market approval application to the US Food and Drug Administration (FDA) in late 2018.

The Lutonix below-the-knee trial is a prospective, multicentre, randomised, 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 ischaemia patients with stenotic or occlusive lesions in the below-the-knee arteries.

The Lutonix below-the-knee trial is the only on-going DCB trial for below-the-knee arteries in the USA and has enrolled more than 450 patients over the past four years.

The Lutonix 014 DCB product for below-the-knee has been commercially available in Europe, Canada and Australia for treatment of the arteries associated with critical limb ischaemia since 2013.


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