Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: GERD
Treatment: Transoral incisionless fundoplication
The health plan should not cover the Transoral incisionless fundoplication.
The Transoral incisionless fundoplication is not likely to be more beneficial.

The EsophyX system (EndoGastric Solutions, Inc., Redmond, WA) creates a transoral incisionless fundoplication (TIF). The EsophyX system deploys multiple full thickness serosa-to-serosa fasteners into the gastric wall to form an interrupted suture line at the base of the gastroesophageal junction, thus recreating the gastroesophageal valve mechanically. This is sometimes referred to as the endoluminal fundoplication (ELF) technique. The predicate device to the EsophyX system is the StomaphyX (EndoGastric Solutions, Inc., Redmond, WA) (Demyttenaere, et al., 2010).  

U.S. Food and Drug Administration (FDA): The EndoCinch or Bard Endoscopic Suturing System (FDA, 2000b), NDO Surgical Endoscopic Plication System (FDA, 2003), EsophyX System (FDA, 2007), EsophyX2 System (FDA, 2009), SRS Endoscopic Stapling System (FDA, 2012) and StomaphyX (FDA, 2007) have been approved through the 510(k) premarket notification process. The Syntheon ARD Plicator is not an FDA approved device.

The Bard Endoscopic Suturing System FDA indications for use state, "used for endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for the approximation of tissue for the treatment of symptomatic GERD" (FDA, 2000b).

The EsophyX2 System FDA indications for use state, "indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease" (FDA, 2009b).

Evidence in the published, peer-reviewed scientific literature on the efficacy of transoral incisionless fundoplication (TIF) using the EsophyX system largely consists of case series with small patient populations (n=10-60). While these case series report improvements in outcomes following treatment with EsophyX, the lack of control group precludes the ability to generalize findings and draw strong conclusions regarding the impact on health outcomes (Wilson, et al., 2014; Muls, et al., 2013; Trad, et al., 2012; Narsule, et al., 2012; Testoni, et al., 2012; Frazzoni, et al., 2011; Bell, et al., 2011; Hoppo, et al., 2010; Velanovish, et al., 2010; Testoni, et al., 2010; Demyttenaere et al., 2010; Cadiere, et al., 2009; Repici, et al., 2010) . Randomized controlled trials with longer follow-up are needed to determine whether EsophyX improves outcomes compared to alternative treatment modalities.

The 2015 ASGE Practice Guideline on the role of endoscopy in the management of GERD includes a discussion of endoluminal therapies including the delivery of thermal energy. ASGE stated that there are only two endoluminal GERD therapies being used in the United States: the Stretta procedure and the Transoral Incisionless Fundoplication (TIF) (EsophyX device). Following a discussion of the studies for these two procedures, ASGE stated that the endoluminal antireflux procedures represent potentially, new therapeutic indications for GI (gastrointestinal) endoscopy and that appropriate patient selection and endoscopist experience and training should be "carefully considered" before pursuing these therapies. AGSE did not recommend the use of these therapies, but suggested that endoscopic antireflux therapy be considered for selected patients with uncomplicated GERD after careful discussion with the patient regarding potential adverse effects, benefits, and other available therapeutic options.