Zoll Medical Corporation
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
Inclusion Criteria: * Severe sleep disordered breathing * Expected to tolerate study procedures * No heart failure or medically stable heart failure Exclusion Criteria: * Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval * History of severe COPD or pulmonary arterial hypertension * Current or previous history of nerve injury or palsy * Prior cervical surgeries or radiation treatment to head region * Known need for an MRI * History of psychosis or severe bipolar disorder * Active Infection or sepsis within 30 days of enrollment * Currentl…
implant of dual channel stimulation device
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