At this meeting, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro Rechargeable System sponsored by Enteromedics, Inc.
June 17, 2014 8:00 a.m. to 6:00 p.m.: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
At this meeting, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro Rechargeable System sponsored by Enteromedics, Inc. The Maestro Rechargeable System provides VBLOC Therapy. The implantable device is a neuromodulator, which delivers high frequency (5000 Hertz), controllable electrical pulses to the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is reported to suppress neural signals carried by the vagus nerve trunks, resulting in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety. The device consists of implantable electronic device components that deliver VBLOC therapy, and external components that regulate device performance.
The Maestro Rechargeable System is indicated for use in weight reduction in adult patients with obesity that have a Body Mass Index (BMI) of at least 40 kilograms per square meter (kg/m2), or a BMI of at least 35 kg/m2 with one or more obesity related comorbid conditions, and have failed a more conservative weight reduction alternative.
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