At this meeting, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory discussed, made recommendations, and voted on information regarding the premarket application (PMA) for the Maestro Rechargeable System sponsored by Enteromedics, Inc.
At this meeting, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory discussed, made recommendations, and voted on information regarding the premarket application (PMA) for the Maestro Rechargeable System sponsored by Enteromedics, Inc. The Maestro Rechargeable System provides vagal blocking (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.
There were several questions posed to the committee during this meeting. Importantly, for the question regarding whether the panel felt that the Maestro Rechargeable System VBLOC therapy is safe for use in patients as indicated, 8 panelists voted yes and 1 voted no. Additionally, 4 panelists voted in favor of the system’s efficacy for use in patients as indicated while the other 5 voted against its efficacy. Lastly, 6 panelists voted that the system’s benefits outweighed its risks while 2 voted that they didn’t, and one panelist abstained.
In the device’s primary trial, ReCharge, investigators found that in patients randomly assigned to VBLOC, the average excess weight loss 24.4% at 12 months compared with 15.9% for patients randomly assigned to the control treatment (i.e. “sham” implants).
Additionally, 52.5% of VBLOC patients had excess weight loss of at least 20% and 38.4% had excess weight loss of at least 25%.
Interestingly, some participants of the ReCharge trial spoke during the open public hearing session of the meeting; several spoke in favor of recommending the device approval while 1 person recommended against approval.
Some panelists felt the trial did not accurately represent the severe obesity population intended, the lack of long-term data, and the fact that the device is unsafe for patients who need magnetic resonance imaging, likening it to pacemakers in that regard. Laurén A. Doamekpor, PhD, senior fellow with the National Center for Health Research, recommended against approval because of the unmet endpoints and because she felt that it was “unacceptable that there is so little diversity in the ReCharge trial.”
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