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.
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.
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.
Implant/revision procedure, device, or therapy-related serious adverse event rate at 12 months. Does not include general surgical complications.
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.
Adverse event comparison between P130019 SSED, Lap Band SSED (P000008), Realize Band SSED (P070009).