2 The technology

Description of the technology

2.1 GreenLight XPS (Boston Scientific) is intended to treat benign prostatic hyperplasia (BPH) using photoselective vaporisation of prostatic tissue. The procedure can be done either as day-case or inpatient treatment. A laser fibre is passed through a cystoscope to vaporise the enlarged prostate, leaving a clear urethral channel. In 'coagulation' mode, GreenLight XPS can also seal (cauterise) any bleeding vessels that may result from photoselective vaporisation.

2.2 The GreenLight XPS laser operates at a shorter wavelength (532 nanometres) than other laser systems used to treat BPH. Shorter wavelength light is absorbed by oxyhaemoglobin (in blood and tissue), which vaporises the tissue, leaving no fragments behind. GreenLight XPS uses a proprietary MoXy laser fibre, which is actively cooled using a flow of saline to improve fibre durability.

2.3 Since its introduction in 2005, the GreenLight console has been upgraded to provide an increase in power output. This allows procedures to be done on larger prostates in less time. The first clinical studies used an 80 watt system; this was then upgraded to a 120 watt system (GreenLight HPS) and a further upgrade in 2010 introduced GreenLight XPS, the 180 watt system currently in use. GreenLight XPS also has an improved laser fibre design to accommodate the increase in power output to avoid fibre degradation. This is designed to allow the use of 1 fibre per patient in all but the largest prostates.

2.4 The GreenLight XPS console is a class IIB device, and the MoXy disposable laser fibre is a class IIA device. The first version of GreenLight was CE marked in 2005; GreenLight XPS and its associated MoXy fibre were CE marked in 2010.

2.5 The company submission stated that the GreenLight XPS laser console is usually provided at no cost to the NHS, as part of a contractual arrangement with the company to purchase a minimum number of laser fibres over a specified time period at an average price of £550 per fibre (excluding VAT).

2.6 The claimed benefits of GreenLight XPS in the case for adoption presented by the company were:

  • Shorter hospital length of stay, because the GreenLight XPS procedure can be done as a day-case procedure.

  • Shorter duration of catheterisation.

  • Quicker return to normal activity following treatment.

  • Reduction in patient stress and anxiety because typically no overnight stay is needed.

  • Reduction in pain leading to improved quality of life

  • May be used in patients taking anticoagulants and those with larger prostates.

  • Reduction in hospital readmissions

  • Reduced risk of adverse events from capsular perforation, bleeding and transurethral resection of the prostate (TURP) syndrome.

Current management

2.7 Current management for men with BPH is outlined in NICE's guideline on lower urinary tract symptoms and in the NICE pathway on lower urinary tract symptoms in men. Surgical options recommended by NICE include:

  • monopolar or bipolar TURP (see NICE medical technologies guidance on the TURis system for transurethral resection of the prostate)

  • transurethral vaporisation of the prostate (TUVP)

  • holmium laser enucleation of the prostate (HoLEP)

  • transurethral incision of the prostate (TUIP; only in prostates smaller than 30 ml)

  • open prostatectomy (only in prostates larger than 80 ml).

2.8 Minimally invasive treatments such as transurethral needle ablation (TUNA), transurethral microwave thermotherapy (TUMT), high-intensity focused ultrasound (HIFU), transurethral ethanol ablation of the prostate (TEAP) and laser coagulation are not recommended by NICE. In NICE's guideline on lower urinary tract symptoms, laser vaporisation techniques (such as GreenLight XPS) are recommended for use only as part of a randomised controlled trial that compares these techniques with TURP. NICE has also recommended the UroLift prostatic urethral lift system as an alternative treatment option (see NICE medical technologies guidance on UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia).

  • National Institute for Health and Care Excellence (NICE)