Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy
Medtronic
Summary
The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptiv™ Spinal Cord Stimulation therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18 years of age or older 2. Patient must be SCS therapy naïve 3. A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study. 4. Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable 5. Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat 6. Patient must have an on-label indication…
Interventions
- DeviceCommercially available Inceptiv™ neurostimulation systems
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available Inceptiv™ neurostimulation systems
Locations (3)
- Center for Pain and Supportive CarePhoenix, Arizona
- Christian HospitalSt Louis, Missouri
- North Texas Orthopedics and Spine CenterHouston, Texas