Bariatric Times

MAR 2016

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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18 Emerging Technologies Bariatric Times • March 2016 m ore weight, but not all. Also, a significant number of patients will likely experience weight regain. In these case, patients will need to continue to address the obesity by c onsidering either a sequential balloon or bariatric surgery if they qualify. The future for endoluminal bariatric therapies looks promising a s the FDA is evaluating several procedures. On the balloon technologies front, we have two other devices that are undergoing US clinical trials: the Obalon b alloon (Obalon Therapeutics, Inc., San Diego, California) and the Elipse balloon (Allurion Technologies, Wellesley, Massachusetts) T he Obalon balloon includes a small capsule attached to a tube. The patient swallows the capsule with a glass of water. No sedation is required. Gas is used to inflate the b alloon, and the tube is removed. Up to 3 balloons can be placed to continue to facilitate weight loss over the six-month treatment. At the end of this period, the balloons are removed in a short endoscopic procedure in which the patient is placed under sedation. 14 The Elipse balloon is also delivered in a swallowable capsule and filled with liquid through a thin delivery catheter, which is then detached. It remains in the stomach for four months, after which it automatically empties and is excreted naturally through the patient's gastrointestinal tract. 15 All these therapies will enable us to have more options for our patients. CONCLUSION Studies have shown that intragastric balloon systems are an effective means of weight loss in patients suffering from obesity with B MIs 30 to 40kg/m 2 c ompared to diet/exercise management alone (2–3 times better weight loss). Risk factors/limitations of the device include poor weight loss in up to 25 p ercent of the patients, nausea and vomiting in 60 to 90 percent, intolerance requiring early removal in 7.5 percent, and ulcers in 2 to 10 percent. Balloons are an effective a nd welcomed addition to the bariatric surgeon's armamentarium for obesity treatment. REFERENCES 1. Benjamin SB, Maher KA, Cattau EL Jr, et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for e xogenous obesity. Gastroenterology. 1988;95(3):581–588. 2. Ulicny KS Jr, Goldberg SJ, Harper WJ, et al. Surgical complications of the Garren-Edwards Gastric Bubble. Surg Gynecol Obstet. 1988;166:535–540. 3. Genco A, Bruni T, Doldi SB, et al. Bioenteric intragastric balloon: the Italian experience with 2515 patients. Obes Surg. 2005;15:1161–1164. 4. Sallet JA, Marchesini JB, Paiva DS, et al. Brazilian multicenter study of the intragastric balloon. Obes Surg 2004;14:991-98. 5. Lopez-Nava G, Rubio MA, Prados S, et al. Bioenterics intragastric balloon (BIB®). Single ambulatory center Spanish experience with 714 consecutive patients treated with one or two consecutive balloons. Obes Surg. 2011;21:5–9. 6. Imaz I, Martínez-Cervell C, García- Alvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. O bes Surg. 2008;18:841–846. 7. Ponce J, Quebbeman BB, Patterson EJ. Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual- balloon in obesity. Surg Obes Relat Dis. 2012;9: 290–295. 8. Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11:874–881. 9. Abu Dayyeh, BK, Kumar, N, Edmundowicz SA, et al. ASGE Bariatric Endoscopy Task Force s ystematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015;82:425–438. 10. Lopez-Nava G, Bautista-Castaño I, Jimenez-Baños A, et al. Dual intragastric balloon: single ambulatory center spanish experience with 60 patients in endoscopic weight loss management. Obes Surg. 2015;25:2263–2267.) 11. Orbera™ Intragastric Balloon System FDA Summary of Safety and Effectiveness Data: http://www.accessdata.fda.gov/cdrh_ docs/pdf14/P140008b.pdf Accessed November 28, 2015 12. ORBERA™ Intragastric Balloon System. Directions for Use (DFU). August 2015. www.orbera.com/dfu. Accessed November 28, 2015 13. Ponce J, Nguyen NT, Hutter M, Sudan R, Morton JM. Estimation of Bariatric Surgery procedures in the United States 2011–2014. American Society for Metabolic and Bariatric S urgery Brief Communication. Surg Obes Relat Dis. 2015; in press. 14. Obalon Safety Information. http://www.obalon.com/safety- information/. Accessed February 12, 2015 15. Allurion Technologies' Elipse™ Gastric Balloon Receives European Marketing Approval. http://www.marketwired.com/press- release/-2080164.htm. Accessed February 12, 2015 F UNDING: No funding was provided. DISCLOSURES: The author reports the following disclosures relevant to the content of this article: ReShape Medical, Inc. (San Clemente, California): consultant, FDA clinical trial investigator; Obalon Therapeutics, Inc. (San Diego, California): FDA clinical trial investigator; USGI Medical, Inc. (San Clemente, California): FDA clinical trial investigator; W. L. Gore and Associates, Inc. (Flagstaff, Arizona): consultant, speaker; Olympus Corporation (Tokyo, Japan): speaker; ConMed (Utica, New York): consultant. ADDRESS FOR CORRESPONDENCE: Jaime Ponce, MS, FACS, FASMBS; E-mail: jponcemd@gmail.com NEW from Bariatric Times and Matrix Medical Communications consumer division Matrix Consumer Health PRESCRIPTION SAVINGS FOR PATIENTS Help your patients control their healthcare costs Copy this FREE prescription savings card and offer to interested patients

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