Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. Maestro Rechargeable System (EnteroMedics Inc.) for vagal blocking for obesity control. Lansdale: HAYES, Inc.. Healthcare Technology Brief Publication. 2016 Authors' conclusions Description of Technology: The Maestro Rechargeable System is a pacemaker-type device that is designed to intermittently deliver electrical pulses to the vagus nerve in order to transiently block vagal nerve signals between the stomach and brain, thereby reducing appetite and, consequently, weight. The device consists of an implanted, programmable, battery-operated neuroregulator that generates electrical pulses; 2 implanted electrode/lead wire systems that carry and deliver these pulses from the neurogenerator to the 2 vagal nerve trunks; and 3 external components that transcutaneously recharge the neuroregulator battery, program the neuroregulator, or provide battery-charging or therapy-programming information to the neuroregulator. The implantation procedure is performed by a bariatric surgeon on an outpatient basis, uses general anesthesia and laparoscopic techniques, and takes 60 to 90 minutes. After recovery from surgery, a physician programs the neuroregulator to deliver therapy on a patient-customized basis; and the patient is instructed to use the device for 9 waking hours daily, to remove external components while sleeping, and to recharge the device routinely.
Patient Population: The Maestro Rechargeable System is indicated for reducing weight in adults (aged 18 years) with a body mass index (BMI) 40 kilograms per square meter (kg/m2) or a BMI 35 to 39.9 kg/m2 with 1 obesity-related comorbid conditions who have failed at least 1 supervised weight management program within the past 5 years. Indexing Status Subject indexing assigned by CRD MeSH Humans; Obesity; Vagus Nerve Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32016000789 Date abstract record published 15/06/2016 |