Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy
Overview
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.
Information coming soon.
Sex: ALL
Minimum Age: 22 Years
Healthy Volunteers: No
Age Groups: ADULT, OLDER_ADULT
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
* Currently on kidney dialysis or significantly reduced kidney function
* Hemoglobin less than 8g/dl
* Pacemaker dependance
* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
* Allergy to contrast dye unless can be prophylactically treated
* Known pregnancy or planning to become pregnant