Study Using the SpinalStim Device Following Lumbar Fusion Surgery

Inclusion Criteria

• •1. Male or female, ≥ 18 years of age at the time of Informed Consent
• •2. Requires a lumbar fusion surgery within 30 days of signing Informed Consent.
• •a. Surgical approach is according to physician's discretion.
• •3. Subject has one or more risk factors:
• •* Is currently using nicotine
• •* multi-level lumbar fusion surgery planned
• •* Prior failed fusion at any lumbar level
• •* Subject reported diabetes
• •* Subject reported osteoporosis
• •4. Body mass index ≤ 45 kg/m2 at the time of consent.
• •5. Must have reliable access to an iPhone or an iPad with Wi-Fi access for downloading the free device-specific app (iPhone 5S or higher, iPad, iPad Pro, iPad mini or iTouch using iOS v9.3 or later). When the android version of the mobile app for the SpinalStim becomes available (estimated to be Dec. 2017), subjects who have reliable access to devices using android operating systems will be eligible for study inclusion.
• •6. Able and willing to complete electronic questionnaires and able to read and understand study instructions in English
• •7. Able and willing to comply with the study plan and able to understand and sign the study-specific ICF.