Algovita Spinal Cord Stimulation System Hi-Fi Study

Inclusion Criteria

• •Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
• •Age 18-75 years old at consent.
• •Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
• •ODI score of 41-80 out of 100 at the Baseline visit.
• •Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
• •On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
• •Willing and capable of providing informed consent.
• •Willing and able of complying with the study-related requirements, procedures, and visits.
• •Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
• •Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.