NICE has developed a medtech innovation briefing (MIB) on the Stretta System for gastro-oesophageal reflux disease.
- The technology described in this briefing is the Stretta System. It applies radiofrequency (RF) energy to the lower oesophageal sphincter and gastric cardia to improve symptoms of gastro-oesophageal reflux disease (GORD).
- The innovative aspects are that this is the only RF energy device for treating GORD. Stretta Therapy is minimally invasive and can be done under sedation in an outpatient endoscopy suite, or under general anaesthesia as a day case procedure.
- The intended place in therapy would be for treating GORD symptoms, which cannot be controlled using proton pump inhibitor (PPI) medication therapy, alongside surgery, or before surgery. NICE interventional procedures guidance on endoscopic radiofrequency ablation for gastro-oesophageal reflux disease recommends that, because of uncertainty over longer-term safety and inconclusive efficacy evidence, the procedure should only be used with special arrangements for clinical governance, consent and audit or research.
- The key points from the evidence summarised in this briefing come from 5 studies (n=588) published after the interventional procedures guidance was published. The evidence suggests that Stretta Therapy improves symptom scores and reduces PPI medication dependence up to 5 years after treatment when compared with baseline. No additional objective efficacy evidence has been published.
- Key uncertainties around the evidence are that none of the published studies were set in the UK. There are no comparative studies of Stretta Therapy against other endoscopic treatments of GORD.
- The Stretta System costs £2,495 for the single-use delivery catheter and £25,000 for the reusable RF generator, excluding VAT.
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.