NICE has developed a medtech innovation briefing (MIB) on the Lutonix drug-coated balloon for peripheral arterial disease.

  • The technology described in this briefing is the Lutonix drug-coated balloon (DCB; also known as the Lutonix 035). It is a paclitaxel-coated percutaneous transluminal angioplasty (PTA) catheter. It is indicated for treating peripheral arterial disease (PAD).
  • The innovative aspects are that Lutonix DCB has a lower paclitaxel concentration than alternative devices and a drug delivery mechanism that is claimed to be novel.
  • The intended place in therapy would be as an alternative to other reconstructive options for PAD such as standard or plain balloon PTA, or bypass grafting.
  • The key points from the evidence summarised in this briefing are from 2 randomised trials (LEVANT studies I and II; n=101 and 476) comparing the Lutonix DCB with standard angioplasty using non-coated balloons in patients with symptomatic femoropopliteal PAD. The Lutonix DCB showed significantly lower late lumen loss rates at 6 months post-procedure with a similar complication rate to standard balloon angioplasty. Two non-comparative, retrospective case series (Steiner et al. 2016 and Micari et al. 2016) indicate that the Lutonix DCB is a potentially viable treatment for below-the-knee PAD, with acceptable outcomes and safety rates.
  • Key uncertainties around the evidence are that the primary outcome of the 2 randomised studies is late lumen loss. This is considered to be a technical outcome so its clinical impact is unclear. The additional clinical evidence comprises retrospective non-comparative case series (n=246 and n=55).
  • The cost of Lutonix DCB is £580 per unit (exclusive of VAT). The resource impact, other than the device cost, should be similar to standard angioplasty balloon procedures.

MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.

Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.

MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.

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.