BlueCross BlueShield of Tennessee Medical Policy Manual

Minimally Invasive Procedures for Weight Loss


Minimally invasive procedures involving a variety of gastrointestinal devices and techniques are being investigated for individuals who are morbidly obese, have regained weight following weight loss surgery and/or have diabetes.

Endoluminal (also called endosurgical, endoscopic, or natural orifice) bariatric procedures access the stomach through the mouth without skin incisions. Examples of endoluminal bariatric devices include a duodenojejunal sleeve or liner (e.g., the EndoBarrier® Gastrointestinal Liner) and gastric balloons. The implantable liner (e.g., the EndoBarrier® Gastrointestinal Liner) is an impermeable fluoropolymer liner that will allow partially digested food leaving the stomach to move through the gastrointestinal tract without mixing with digestive enzymes or allowing nutrients to be absorbed. Under general anesthesia, the liner is deployed through a catheter, anchored within the duodenum and left in place. The device can be removed endoscopically by using the liner drawstrings to collapse and retract the anchor barbs. Balloon devices (e.g. SilimedTM, ReShape DuoTM) are two connected saline filled balloons inserted into the stomach through the mouth. Two connected balloons are used due to earlier single-balloon versions dislodging and migrating down the digestive tract, causing an obstruction.

Restrictive bariatric procedures, that do not devices behind are also being investigated.  In the greater curve plication or total vertical gastric plication the stomach is accessed endoscopically and numerous pleats or imbrications are created to reduce the volume of the gastric cavity. The pleats are sutured or stapled in place (e.g. EndoCinch™, StomaphyX™, EsophyX™, NDO Plicator™). The Transoral Gastric Volume Reduction (TGVR) is a relatively new restrictive procedure that works by sewing the sides of the stomach to create a feeling of fullness. The Primary Obesity Surgery Endolumenal (POSETM) Procedure is for those who have not had weight loss surgery in the past and are seeking more conservative weight loss results. It reduces the size of the stomach by creating folds and anchoring them in place with sutures.  


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Data is lacking from of peer published evidence-based, well-designed studies and non-industry based randomized controlled trials to determine whether the use of these minimally invasive procedures improve net health outcomes.

Currently, the EndoBarrier® Gastrointestinal Liner has not been approved by the U. S. Food and Drug Administration.


American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic and Bariatric Surgery. (March 2013) Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient - 2013 update. Retrieved July 21, 2015 from: (NCG#010217)

American Society for Gastrointestinal Endoscopy/ American Society for Metabolic and Bariatric Surgery Task Force on Endoscopic Bariatric Therapy. (2011). A pathway to endoscopic bariatric therapies. Gastrointestinal Endoscopy, 74 (5), 943-953.

American Society for Metabolic and Bariatric Surgery. (2009). Position statement on emerging endosurgical interventions for the treatment of obesity, Surgery for Obesity and Related Diseases. 5 (2009), 297-298.

American Society for Metabolic and Bariatric Surgery. (2011). Policy statement on gastric plication. Retrieved November 25, 2013 from:

California Technology Assessment Forum. (May 2015). Controversies in obesity management. May 26, 2015. Retrieved July 21, 2015 from: (477 articles and/or guidelines reviewed)

de Moura, E. G., Martins, B. C., Lopes, G. S., Orso, I. R., de Oliverira, S. L., Galvao Neto, M. P., et al. (2012). Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technology & Therapeutics, 14 (12), 183-189. (Level 2 Evidence - Industry sponsored)

Gersin, K., Keller, J., Stefanidis, D., Simms, C., Abraham, D., Deal, S., et al. (2007). Duodenal-jejunal bypass sleeve: A totally endoscopic device for the treatment of morbid obesity. Surgical Innovation, 14 (4), 275-278.

Gersin, K., Rothstein, R., Rosenthal, R., Stefanidis, D., Deal, S., Kuwada, T., et al. (2010). Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates. Gastrointestinal Endoscopy, 71 (6), 976-982. (Level 2 Evidence - Industry sponsored)

National Institute for Health and Clinical Excellence. (2012, November). Laparoscopic gastric plication for the treatment of severe obesity. Retrieved November 25, 2013 from

Ramos, A., Neto, M, Galvao, M., Evangelista, L., Campos, J., & Ferraz, A. (2010). Laparoscopic greater curvature plication: Initial results of an alternative restrictive bariatric procedure. Obesity Surgery, 2010 (20), 913-918. (Level 4 Evidence – Industry supported)

Rodriquez, L., Reves, E., Fagalde, P., Oltra, M. S., Saba, J., Aylwin, C. G., et al. (2009). Pilot clinical: Study of an endoscopic, removable duodenal-jejunal bypass liner for the treatment of type 2 diabetes. Diabetes Technology & Therapeutics, 11 (11), 725-732. (Level 2 Evidence - Industry sponsored)

Ryou, M., Ryan, M., & Thompson, C. (2011). Current status of endoluminal bariatric procedures for primary and revision indications. Gastrointestinal Endoscopy Clinics of North America, 21 (2), 315-333.

Schouten ,R., Rijs, C., Bouvy, N., Hameeteman, W., Koek, G., Janssen, I., Greve, J., et al. (2010). A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery. Annals of Surgery, 251 (2), 236-243. (Level 2 Evidence - Industry sponsored)

Stylopoulos, N., & Aguirre, V. (2009). Mechanisms of bariatric surgery and implications for the development of endoluminal therapies for obesity. Gastrointestinal Endoscopy, 70 (6), 1167-1175.

Talebpour, M., & Amoli, B. (2007). Laparoscopic total gastric vertical plication in morbid obesity. Journal of Laparoscopic and Advanced Surgical Techniques, 17 (6), 793-798.

U. S. Food and Drug Administration. (2007. September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K071553. Retrieved November 25, 2013 from

U. S. Food and Drug Administration. (2012, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120147. Retrieved November 25, 2013 from

Vanguri, P., Brengman, M., Oiticica, C., Wickham, E., Bean, M., and Lanning, D. (February 2014) Laparoscopic gastric plication in the morbidly obese adolescent patient. Seminar of Pediatric Surgery 23(1): 24–30.

Verdam, F., Schouten, R., Greve, J., Koek, G., & Bouvy, N. (2012). An update on less invasive and endoscopic techniques mimicking the effect of bariatric surgery. Journal of Obesity, 2012 (epub).




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