The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy
Timeframe: 5 years
Evaluate changes in sleep disordered breathing metrics after 12 months of therapy
Timeframe: 12 months