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.