Advice
The technology
The technology
The Stretta System is a radiofrequency (RF) energy device intended to treat gastro-oesophageal reflux disease (GORD). During the procedure, known as Stretta Therapy, RF energy is delivered to treatment sites above and below the gastro-oesophageal junction. The manufacturer states that Stretta Therapy is non‑ablative because it does not remove or destroy tissue, but regenerates the target tissue by creating hypertrophy that thickens the musculature to improve GORD symptoms.
The Stretta System consists of a reusable, pole-mounted 4‑channel RF generator and a sterile, single-use RF-delivery catheter that houses 4 needle electrodes. A single-use, gel-type patient return electrode completes the RF circuit. It delivers low power (5 Watt) thermal energy at 65ºC–85ºC. The generator has an integrated irrigation pump to cool the mucosal tissue during therapy and a colour display to guide the user through equipment setup and the treatment procedure. The catheter consists of an inflatable and flexible balloon-basket with 4 needle electrodes positioned radially at 90° angles from one another around the balloon. Electrode tip and surface tissue temperatures are measured by thermocouples in the tip and base of the electrode respectively. The operator controls energy delivery through a footswitch.
To begin treatment, the distance to the gastro-oesophageal junction is measured using an endoscope and then a guide wire with a flexible tip is passed through the endoscope into the stomach, where it stays during the treatment session. The endoscope is withdrawn and the RF-delivery catheter is inserted, following the guide wire. The manufacturer recommends that Stretta Therapy is carried out at 6 different points in the oesophagus: 4 across the lower oesophageal sphincter muscle, 1 at the gastro-oesophageal junction, and 1 in the gastric cardia. Typically, Stretta Therapy takes less than 1 hour and the person returns to normal activity the next day.
The innovation
The Stretta System is the only RF energy device indicated for treating GORD. Stretta Therapy is a minimally invasive procedure that can be done as an outpatient or day case procedure.
Current NHS options
The NICE guideline on gastro-oesophageal reflux disease and dyspepsia in adults recommends lifestyle modifications such as weight reduction or smoking cessation, and gastric acidity-lowering medication to improve symptoms. People whose symptoms do not respond to medication or lifestyle changes, who develop complications despite medication, or who develop intolerance to medication may be considered for anti-reflux surgery. Most often this is laparoscopic or open fundoplication, but alternative interventional procedures which are covered by NICE guidance are available: laparoscopic insertion of a magnetic bead band such as LINX, endoluminal gastroplication, or electrical stimulation of the lower oesophageal sphincter.
NICE interventional procedures guidance on endoscopic radiofrequency ablation for gastro-oesophageal reflux disease recommends that the procedure should only be used with special arrangements for clinical governance, consent and audit or research. This is because, although the evidence on the safety of the procedure is adequate in the short and medium term, there is uncertainty about longer-term outcomes. In addition, there is evidence of symptomatic relief but objective evidence on reduction of reflux is inconclusive.
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; 2013) recommends Stretta Therapy for people 18 years and over with GORD: who have had symptoms of heartburn, regurgitation, or both for 6 months or more; whose condition has been partially or completely responsive to medication; and who have declined laparoscopic fundoplication.
NICE is unaware of other CE-marked RF devices used for treating GORD.
Population, setting and likely place in therapy
According to the manufacturer, Stretta Therapy is indicated for adults with GORD if: conservative treatment options have failed; they are concerned about the risks of long-term medication; surgery is unsuitable for them; or they do not want to have invasive surgery. The manufacturer describes Stretta Therapy as a treatment that fits between medicine and surgery and does not prevent a patient having more invasive options in the future if needed.
The manufacturer states that Stretta Therapy should not be used in people who: are under 18 years; pregnant; without GORD; with a hiatal hernia more than 2 cm in size, with achalasia or incomplete lower oesophageal sphincter relaxation in response to swallowing; or who are not suitable for surgery (American Society of Anesthesiologists [ASA] classification IV).
Stretta Therapy is typically carried out under sedation, in an endoscopy suite. It can also be done with general anaesthesia as a day case procedure, depending on patient or centre preference. The procedure is done by a gastroenterologist or upper gastrointestinal surgeon trained in using the Stretta System.
Costs
Table 1 Prices of standard components (excluding VAT)
|
Component |
Price |
Other information |
|
Stretta RF-delivery catheter |
£2,495 |
Single use. |
|
RF generator |
£25,000 |
Reusable (anticipated lifespan of 5 years or 1,000 uses). |
|
Compatible patient return electrode (third party) |
£4.04 (NHS Supply Chain) |
Single use. |
|
Training |
Free of charge |
Includes web-based, hands-on, and supervised training during the first 6 procedures. |
|
Maintenance |
Done in-house |
Includes annual safety testing and checking RF output level. |
Costs of standard care
The REFLUX Health Technology Assessment (2008) estimated a mean (standard deviation) cost of laparoscopic Nissen fundoplication of £2,787 (£175) based on a survey of 5 UK centres. Variation in costs between centres was caused by differences in staffing and use of disposables.
No information on the NHS costs of alternative therapeutic endoscopic procedures for GORD was found in the public domain.
Resource consequences
A literature search was carried out to identify any relevant cost or resource evidence for the technology.
The literature search identified 3 economic studies on Stretta Therapy, all done outside the UK.
Funk et al. (2015) developed a Markov model with a 30‑year time frame, which predicted that treatment with proton pump inhibitor (PPI) drugs (twice-daily low-dose omeprazole) would have the lowest cost-effectiveness ratio ($541 per quality-adjusted life year [QALY] gained; American dollars), followed by Stretta Therapy (US$642/QALY), laparoscopic Nissen fundoplication (LNF; US$716/QALY) and endoscopic fundoplication (EsophyX; $1,067/QALY) over a 30‑year time frame. At a 6‑month cost of $204 for PPI, sensitivity analyses showed that PPI was the cheapest treatment option, with Stretta and LNF being cost-effective treatments. Stretta was not the most cost-effective treatment because the study assumed a failure rate of Stretta at a probability of 0.205 every 6 months. All Stretta procedures were assumed to occur in an outpatient endoscopy suite under conscious sedation, and the purchase cost of the Stretta System was not included in the model.
The Markov model by Comay et al. (2008) showed that if symptom-free months (SFM) were used as a measure of effectiveness, daily PPI therapy cost the least ($40/SFM, Canadian dollars) when compared with Stretta Therapy ($57/SFM) and LNF ($127/SFM) over a 5‑year time frame. When efficacy was measured in QALYs, PPI therapy still had the lowest cost-effectiveness ratio.
The decision tree model applying a cost minimisation approach by Harewood and Gostout (2003) found that PPI therapy was the most economical strategy in patients needing once-daily treatment. PPI therapy was also most economical in patients needing twice-daily medication up to 17 months and beyond 29 months. Between 17 and 29 months, endoluminal gastroplication (using the Endocinch device, which is no longer manufactured) was marginally cheaper than Stretta Therapy.
A retrospective cost analysis of pre- and post-treatment medical claims by Gregory et al. (2016) found that Stretta Therapy was cost saving up to 12 months post-procedure when compared with medical management and fundoplication.
The UK supplier of the Stretta System states that it is currently used in 10 NHS Trusts.
Regulatory information
The Stretta catheter and reusable RF generator were both CE marked to Mederi Therapeutics as Class IIb devices in 2009. The Stretta System is supplied by CJ Medical in the UK.
A search of the Medicines and Healthcare Products Regulatory Agency website revealed that no manufacturer Field Safety Notices or Medical Device Alerts have been issued for this technology.