**Abstract**

Gastroesophageal reflux disease (GERD) is defined by the presence of chronic
symptoms or mucosal damage caused by an abnormal reflux of gastric contents
into the esophagus. GERD may be caused by a weakness in the lower esophageal
sphincter (LES), the presence of a hiatal hernia (HH), transient LES
relaxation, alterations in the gastroesophageal pressure gradient, and
esophageal factors such as poor clearance and changes in motility. Heartburn
(pyrosis) and regurgitation, the most common and highly specific symptoms of
GERD, may be experienced alone or in combination after eating a meal. Severe
complications of GERD include the development of strictures, erosive
esophagitis, and Barrett's esophagus.

The Stretta system (Mederi Therapeutics Inc., Greenwich, Connecticut) is a
radiofrequency (RF) treatment for GERD. The system, including its specialized
catheters and RF generators were originally cleared by the United States
(U.S.) Food and Drug Administration (FDA) for use in 2000 and was issued an
updated clearance on the RF generator in
[2011](https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103017.pdf). The
transoral Stretta catheter system uses a proprietary algorithmic application
of low power (5 Watts) RF energy and generates low tissue temperatures (65C
to 85C) during a series of 1-minute treatment cycles. The endoluminal Stretta
therapy remodels (thickens) the musculature of the LES and gastric cardia.
Clinical results demonstrate that the Stretta RF treatment results in
significant reductions in tissue compliance and transient LES relaxations.
These mechanisms act to restore the natural barrier function of the LES as
well as to significantly reduce spontaneous regurgitation caused by transient
inappropriate relaxations of the sphincter.

**Limitations**

An extensive literature review documented the following information:

The results show that RF treatment significantly improved heartburn scores and
produced significant improvements in quality of life (QOL) as measured by the
GERD Health-Related Quality of Life (GERD-HRQL) scale and the Quality of Life
in Reflux and Dyspepsia (QOLRAD) questionnaire. Esophageal acid exposure
decreased but did not normalize, and while the procedure did not significantly
increase LES pressure, there was a trend toward improvement.

More than 30 peer reviewed studies, including randomized, controlled studies,
a comprehensive meta-analysis and multiple prospective clinical trials have
documented the safety and efficacy of the Stretta procedure. Durable treatment
outcomes to at least 120 months have been demonstrated. In multiple studies,
significant reduction or elimination of medications used to treat the symptoms
of GERD, as well as improvement in GERD QOL and symptom scores have been
demonstrated. Stretta may be recommended as an appropriate therapeutic option
for patients with chronic GERD who meet current indications and patient
selection criteria and choose endoluminal therapy over the gold standard of
laparoscopic fundoplication (Noar, et al. 2014).

Those criteria include:

    * Adult patients (age  18) with symptoms of chronic GERD, heartburn, regurgitation, or both for  6 months who have been partially or completely refractory to antisecretory pharmacologic therapy.
    * Adult patients who do not wish to continue long-term medication use or are not appropriate surgical candidates or do not wish to undergo surgery if there were a less invasive treatment option available. 

The procedure has not been studied and should not be applied in treating
patients with severe esophagitis, hiatal hernias > 2 cm, long segment
Barrett's esophagus, dysphagia, or those with a history of autoimmune disease,
collagen vascular disease, and/or coagulation disorders.

A systematic review and meta-analysis to determine the efficacy of Stretta for
the treatment of GERD was performed. Randomized controlled trials (RCTs) and
cohort studies evaluating the Stretta for treatment of GERD were included in
the analysis, with the search spanning from database inception to May 2016.
The analysis included 28 studies (4 RCTs, 23 cohort studies, 1 registry
study). Pooled results found that Stretta decreased (i.e., improved) mean
health-related QOL score by -14.6 (95% CI, -16.48 to 12.73; P<0.001). Pooled
mean heartburn standardized score was also decreased by Stretta group by -1.53
(95% CI, -1.97 to 1.09; P<0.001). Following Stretta, only 49% of patients who
used proton-pump inhibitors (PPIs) at baseline still needed medication at
follow-up (P<0.001). Reductions in the incidence of erosive esophagitis (24%;
P<0.001) and esophageal acid exposure (mean of -3.01 [95% CI, -3.72 to -2.30];
P<0.001) also occurred with Stretta treatment. However, LES basal pressure was
nonsignificantly increased following Stretta therapy by a mean of 1.73 (95%
CI, -0.29 to 3.74) mm Hg. The authors concluded that subjective and objective
clinical outcomes are improved by the Stretta procedure, and the procedure
should be considered as an alternative for the management of GERD (Fass, et
al. 2017).

A select group of carefully selected patients with chronic reflux would
benefit from Stretta as demonstrated by numerous peer-reviewed publications.
Patients that could benefit from Stretta generally suffer from refractory
symptoms despite adequate treatment with available medications. These patients
do not wish to continue long-term medication use.

Some of these patients are not appropriate surgical candidates or do not wish
to undergo surgery if there were a less invasive treatment option available.
These patients could potentially benefit from a non-invasive procedure such as
Stretta.

Stretta is considered appropriate therapy in a select group of patients being
treated for chronic GERD who are 18 years of age or older, who have had
symptoms of chronic GERD, heartburn, regurgitation, or both for 6 months or
more, who have been partially or completely refractory to antisecretory
pharmacologic therapy, and who have declined laparoscopic fundoplication.