SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study

Exclusion Criteria

• •Any prior spinal fusion at index or adjacent level
• •Pregnant
• •Have a life expectancy of less than 1 year
• •Be concomitantly participating in another clinical study
• •Be involved in an injury claim under current litigation
• •Baseline narcotic use of ≥ 100 MME per day
• •Significant untreated addiction to dependency producing medications
• •Current active implantable medical device
• •Cancer
• •Have osteoporosis
• •Active infection
• •Allergies to system components
• •AGE \> 80
• •Expected need to undergo MRI imaging in the future
• •Other significant comorbidities