Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
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.
• Entry Criteria:
• Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is recommended that a patient have a PSG within 12 months of the expected implant date documenting moderate to severe CSA.
• Age 18 years or older
• Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
• In the opinion of the investigator, subject is willing and able to comply with the protocol.
• Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
• In the opinion of the Investigator, life expectancy exceeds one year.
• The subject is not pregnant or planning to become pregnant.