BlueCross BlueShield of Tennessee Medical Policy Manual

Laparoscopic and Endoscopic Therapies for Gastroesophageal Reflux (GERD)


Due in part to the prevalence of gastroesophageal reflux disease (GERD), there has been interest in creating a minimally invasive alternative to the standard treatments of open or laparoscopic fundoplication (Nissen) or chronic pharmaceutical therapy. The standard treatments are not a part of this policy. In this policy several different types of emerging outpatient procedures have been reviewed:

  1. Transesophageal endoscopic gastroplasty [gastroplication, fundoplication or transoral incisionless fundoplication (TIF)] is a procedure where sutures are placed in the lower esophageal sphincter. The sutures are designed to strengthen and lengthen the sphincter to decrease reflux. Currently there are three endoscopic suturing devices the FDA has given a 510(k) designation (e.g. EndoCinch™, The Plicator™ System and the EsophyX™).

  2. Radiofrequency energy has also been used to produce submucosal thermal lesions at the gastroesophageal junction (e.g. Stretta™). The mechanism of action of the thermal lesions is not precisely known but may be related to ablation of the nerve pathways responsible for sphincter relaxation or may induce a tissue tightening effect related to heat-induced collagen contraction.

  3. Injection or implantation of a prosthetic device or bulking agent to enhance the lower esophageal sphincter. This can be done with a polymer gel (e.g. Enteryx™), or an expandable polyacrylonitrile-based hydrogel (e.g. the Gatekeeper™ Reflux Repair System). Endoscopic submucosal implantations of polymethylmethacrylate (PMMA) beads or pyrolytic carbon-coated zirconium oxide spheres (Durasphere®) have also been used.

  4. More recently a ringed magnetic bead sphincter augmentation device (e.g. LINX® Reflux Management System) placed laparoscopically has been proposed as a treatment for GERD. The magnetic attraction between the beads helps the Lower Esophageal Sphincter (LES) resist opening to gastric pressures, preventing reflux from the stomach into the esophagus. Swallowing forces temporarily break the magnetic bond, allowing food and liquid to pass normally into the stomach. Magnetic attraction closes the LES immediately after swallowing, restoring the barrier to reflux.


See also:  Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Peroral Endoscopic Myotomy (POEM)



For devices and procedures that are still being developed uniformity in diagnosis and long term, randomized controlled trials are needed to compare these procedures to currently accepted treatments such as drug therapy and fundoplication.


Agency for Healthcare Research and Quality. (2011, September). Comparative effectiveness of management strategies for gastroesophageal reflux disease: an update. Retrieved May 9, 2013 from 

American College of Gastroenterology. (2013, March).Guideline for the diagnosis and treatment of gastroesophageal reflux disease. Retrieved March 17, 2014 from

American Gastroenterological Association (2016, April) Technology Coverage Statement on Minimally Invasive Surgical Options for Gastroesophageal Reflux Disease. Retrieved January 18, 2017 from:

American Society for Gastrointestinal Endoscopy (2015) Guideline: The role of endoscopy in the management of GERD. Retrieved March 2, 2017 from:

American Society of General Surgeons (2009) Position statement: transoral fundoplication. Retrieved March 2, 2017 from:

Bell, R., Barnes, W., Carter, B., Sewell, R., Mavrelis, P., and Ihde, G. et. al. (2014, November) Transoral incisionless fundoplication: 2-year results from the prospective multicenter U.S. study. The American Surgeon. Vol 80, No. 11; 1093-1105. (Level 3 evidence – industry sponsored)

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Transesophageal endoscopic therapies for gastroesophageal reflux disease (2.01.38). Retrieved January 17, 2017 from BlueWeb. (40 articles and/or guidelines reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Magnetic Esophageal Ring to Treat Gastroesophageal Reflux (7.01.137). Retrieved January 17, 2017 from BlueWeb. (20 articles and/or guidelines reviewed)

Bonavina, L., Saina, G., Lipham, J. C., DeMeester, T. R., (2013). LINX®  Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux. Therapeutic Advances in Gastroenterology, 6(4) 216-268. (Level 2 evidence)

Brar, T., Dragonov, P., and Yang, D (2017, January) Endoluminal therapy for gastroesophageal reflux disease: In between the pill and the knife? Digestive Diseases and Sciences; 62(1):16-25. Abstract retrieved January 18, 2017 from PubMed database.

ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2013, September). Magnetic sphincter augmentation (LINX® reflux management system) for treating gastroesophageal reflux disease. Retrieved August 28, 2014 from ECRI Institute. (53 articles and/or guidelines reviewed)

Franciosa, M., Triadafilopoulos, G, and Mashima, H. (2013, March) Stretta radiofrequency treatment for GERD: a safe and effective modality. Gastroenterology Research and Practice. Vol 2013, Article ID 783815. (Level 2 evidence)

Ganz, R., Peter, J., Horgan, S., Bemelman, W., Dunst, C.., Edmundowicz, S., et al. (2013). Esophageal sphincter device for gastroesophageal reflux disease. (LINX®) New England Journal of Medicine, 368 98), 719 - 727. (Level 4 evidence - Industry supported)

Hunter, J., Kahrilas, P., Reginald, Bell, C. Wilson, E., Karim, S. et. al., (2015, February) Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology; 148:324-333. (Level 2 evidence - industry sponsored)

Lipham, J. C., Demeester, T. R., Ganz, R. A., Bonavina, L., Saino, G., Dunn, D. H., et al. (2012). The LINX® reflux management system: Confirmed safety and efficacy now at 4 years. Surgical Endoscopy, 26, 2944-2949. (Level 4 evidence - Industry sponsored)

National Institute for Health and Clinical Excellence (NICE). (2012, September). Laparoscopic insertion of a magnetic bead band for gastro-esophageal reflux disease. Retrieved August 28, 2014 from:

National Institute for Health and Clinical Excellence (NICE). (2015, January). Gastro-oesophageal reflux disease in children and young people: diagnosis and management. Retrieved February 10, 2016 from:

National Institute for Health and Clinical Excellence. (2011). Procedural guidance: Endoluminal gastroplication for gastro-oesphageal reflux disease. Retrieved May 9, 2013 from: .

Society of American Gastrointestinal and Endoscopic Surgeons. (2013, May). TAVAC Safety and Effectiveness Analysis: LINX® Reflux Management System. Retrieved September 3, 21014 from:

Society of American Gastrointestinal and Endoscopic Surgeons. (2013, February) Endoluminal treatments for gastroesophageal reflux disease (GERD). Retrieved February 10, 2016 from: (NCG#009740).

Trad, K., Fox, M., Simoni, G., Shughoury, A., Mavrells, P., Raza, M., et. al. (2016, September) Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm.Surgical endoscopy. DOI 10.1007/s00464-016-5252-8. (Level 3 evidence - Industry sponsored)

U. S. Food and Drug Administration. (2003, January). Center for Devices and Radiologic Health Premarket Notification Database P020006 (Enteryx™). Retrieved September 15, 2009 from 

U. S. Food and Drug Administration. (2009, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database, K092400 (EsophyX2®). Retrieved February 15, 2011 from

U. S. Food and Drug Administration. (2012, March). Medical devices. PMA Pre-Market Approval Database. P100049 (LINX™). Retrieved September 2, 2014 from 

Wendling, M., Melvin, W., and Perry, K. (2013, October) Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature. Surgical Endoscopy; 27(10)3735-61. Abstract retrieved March 2, 2017 from PubMed database.

Wilson, E., Barnes, W., Mavrelis, P., Carter, B., Bell, R., Sewell, R., (2014, February) The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience. Surgical Laparoscopic, Endoscopic & Percutaneous Techniques; 24(1):36-46. Abstract retrieved March 2, 2017 from Pubmed database.

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, October last search update August 2016). Endoscopic therapy for gastroesophageal reflux disease. Retrieved January 18, 2017 from  (103 articles and/or guidelines reviewed)

Wisconsin Physician Services (2017, January) Local Coverage Determination (LCD): Endoscopic Treatment of GERD (L34659). Retrieved February 2, 2017 from:




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