Biotronic NRO's Prospera Spinal Cord Stimulation System
Intended to treat for chronic, intractable back pain
Prospera Spinal Cord Stimulation System
FDA has recently approved the Prospera Spinal Cord Stimulation (SCS) System, developed by BIOTRONIK NRO, INC., as a treatment for chronic, difficult-to-manage pain in the trunk or limbs.
This implanted system comprises a rechargeable signal generator connected to one or two leads implanted through the skin, along with clinician and patient programmers and an external trial pulse generator. The implanted generator receives radio signals from a remote control, allowing for adjustments in stimulation parameters.
The system is intended for individuals experiencing chronic, intractable pain associated with conditions such as failed back surgery syndrome, intractable low back pain, and non-surgical refractory back pain.
Clinical studies indicate that similar SCS systems have effectively reduced patient pain scores based on validated assessments like the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), or Patient-reported Pain Relief (PPR).
However, the Prospera SCS System is not suitable for individuals unable to operate it, those who have not experienced effective pain relief during trial stimulation, or those not considered good candidates for spinal cord stimulation surgery.
For more detailed information on the product’s indications and FDA approval, refer to the Summary of Safety and Effectiveness Data (SSED) and product labeling. See the FDA product announcement for links to that information.
Read more about SCS Systems here.