Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that the DCB is safe and effective to use for the treatment of narrowed or obstructed arteries, below the knee. Jihad Mustapha (Grand Rapids, USA), who presented the results as late-breaking data at the Vascular Interventional Advances (VIVA; 5–8 November, Las Vegas, USA) spoke to Vascular News at the conference. He said these results were “a great breakthrough for critical limb ischaemia (CLI) patients with disease below the knee”. “There is now a new therapy for CLI patients that can be used with confidence and is sustainable for up to six months,” he added.
The Lutonix 014 DCB has been submitted to the US Food and Drug Administration (FDA) for this indication.