Enterra Medical

Enterra Therapy has been implanted in over 15,000 patients. It remains the only FDA-approved device under a Humanitarian Device Exemption for treating chronic drug-refractory nausea and vomiting due to gastroparesis. The effectiveness for this indication has not been conclusively demonstrated but it provides an option where other treatments have failed. The system recently received MR Conditional approval from the FDA for certain MRI scans. Clinical data are primarily post-market safety surveillance rather than large-scale randomized trials. The mechanism of action involves gastric electrical stimulation affecting neural pathways between stomach and CNS. Safety reviews continue annually with the FDA Pediatric Advisory Committee.