UK NICE publishes Medtech Innovation Briefing on Lutonix


The UK National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on the Lutonix drug-coated balloon (DCB) for peripheral arterial disease. Lutonix (Bard) is a paclitaxel-coated percutaneous transluminal angioplasty catheter indicated for treating peripheral arterial disease.

Lutonix has a lower paclitaxel concentration than alternative devices and a drug delivery mechanism that is claimed to be novel. This device is intended as an alternative to other reconstructive options for peripheral arterial disease such as standard/plain balloon angioplasty, or bypass grafting.

Two randomised trials (LEVANT I and II) compared the Lutonix DCB with standard angioplasty using non-coated balloons in patients with symptomatic femoropopliteal peripheral arterial disease. Lutonix showed significantly lower late lumen loss rates at six months post-procedure with a similar complication rate to standard balloon angioplasty. In a further two non-comparative, retrospective case series (Steiner et al 2016 and Micari et al 2016) the use of Lutonix produced acceptable outcomes and safety rates indicating that Lutonix is a potentially viable treatment for below-the-knee peripheral arterial disease. Other than the device cost, the additional costs associated with the procedure should be similar to standard angioplasty balloon procedures.

The MIB provides a description of Lutonix, including its likely place in therapy, the costs of using the technology and a critical review of the relevant published evidence, and it provides objective information on Lutonix to aid local decision-making by clinicians, managers and procurement professionals.

MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.

The MIB has been published online at