This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:  Prospera Spinal Cord Stimulation (SCS) Systems
PMA Applicant: BIOTRONIK NRO, INC.
Address: 6024 Jean Road Lake Oswego, OR 97035
Approval Date: March 31, 2023
Approval Letter: Approval Order

What is it?

The Prospera spinal cord stimulation (SCS) system is an implanted spinal cord stimulation system intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage (intractable).

The Prospera SCS includes a rechargeable, implanted pulse (signal) generator that is connected to one or two leads implanted through the skin (percutaneous), a clinician programmer and a patient programmer, and an external trial pulse generator.

How does it work?

The implanted signal generator receives radio signals from the remote control. The signals tell the signal generator the stimulation parameters to deliver to the spinal cord. The external remote control is battery operated and can be controlled by the patient or a health care provider.

When is it used?

The Prospera SCS System is used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided (unilateral) or two-sided (bilateral) pain associated with the following:

• Failed back surgery syndrome
• Intractable low back pain
• Leg pain and intractable back pain without prior surgery where the person is not a candidate for surgery (non-surgical refractory back pain).

What will it accomplish?

The Prospera Spinal Cord Stimulation (SCS) System may help to treat chronic intractable pain in the trunk and/or limbs. Studies of similar spinal cord stimulation systems have shown that SCS systems can be effective at reducing patient pain scores according to validated patient-reported pain assessments such as the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), or the Patient-reported Pain Relief (PPR).

When should it not be used?

The Prospera Spinal Cord Stimulation (SCS) System should not be used in patients who:

• Are unable to operate the SCS system.
• Have not received effective pain relief during trial stimulation.
• Are not good candidates for spinal cord stimulation surgery.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data
• Labeling
• Labeling Part 2
• PMA Database Entry