References

  1. Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Relat Dis. 2013;9(2):159-191.

  2. Market size data on file at EnteroMedics, Inc. Patient Research. Conducted by GFK Healthcare. Dec 2012. Overweight and obese qualified patient interest when presented with device concept. From Draft Surgeon Presentation Content Approved.

  3. Data analysis of 120 patients in the active arm of the ReCharge trial who received 12 hours or more of therapy per day, as directed by the trial protocol. Data on file in PMA P130019 and with EnteroMedics, Inc.

  4. Shikora S, Toouli J, Herrera MF, et al. Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus. J Obes. 2013;2013:245683. doi: 10.1155/2013/245683.

  5. Ikramuddin S, Blackstone RP, Brancatisano A, et al. Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial. JAMA. 2014;312(9):915-922.

  6. ReCharge clinical database on file at EnteroMedics, Inc.

  7. Implant/revision procedure, device, or therapy-related serious adverse event rate at 12 months. Does not include general surgical complications.

  8. Chang S, Stoll CRT, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. 2014;149(3):275-287.

  9. http://www.bariatric-surgery-source.com/

  10. Shikora SA, Wolfe BM, Apovian CM, et al. Sustained weight loss with vagal nerve blockade but not with sham: 18-month results of the ReCharge trial. J Obes. 2015;2015:1-8. http://dx.doi.org/10.1155/2015/365604. Accessed July 30, 2015.

  11. Recharge postop nutrition protocol on file at EnteroMedics, Inc. and FDA IDE study design.

  12. EnteroMedics, Inc. P130019 Maestro rechargeable system for treatment of obesity: briefing document for the gastroenterology and urology devices panel. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM401005.pdf. Published June 17, 2014. Accessed April 1, 2015.