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: Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems
PMA Applicant: Abbott Medical
Address: 6901 Preston Road, Plano, TX 75024 USA
Approval Date: February 15, 2023
Approval Letter: Approval Order

What is it?

Abbott’s Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems are implanted spinal cord stimulation systems intended to treat long-term (chronic) pain in the trunk or limbs that is difficult to manage (intractable).

The main components of these SCS systems are an implanted pulse (signal) generator that is connected to one or two implanted leads, a patient controller, and a clinician programmer.

This supplement expands the Indications for Use to include treatment of diabetic peripheral neuropathy of the lower extremities through a series of consistent stimulation pulses, called the tonic stimulation mode.

How does it work?

The implanted pulse generator (IPG) receives radio signals from the patient controller. The signals tell the IPG when to deliver appropriate stimulation to the spinal cord. Doctors believe stimulation targets specific nerves that impact how pain is perceived and/or nerve structures that aren’t working properly.

When is it used?

Abbott’s Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities.

What will it accomplish?

Data from published research studies support the effectiveness of Abbott’s Prodigy, Proclaim, and Proclaim XR SCS Systems when treating people with chronic, intractable pain of the trunk and/or limbs caused by diabetic peripheral neuropathy of the lower extremities.

Patients reported an average pain relief of 53%, measured using questionnaires, which was maintained for over 5 years at clinically meaningful levels (≥ 50% pain relief). Data from the Medicare database showed that despite increased numbers of implant site infections or other adverse events for people with diabetes, the level of risk remained acceptable for this group.

When should it not be used?

The Abbott Prodigy, Proclaim, and Proclaim XR SCS Systems should not be used in patients who:

• Cannot operate the SCS system
• Have not received effective pain relief during trial stimulation

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

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• PMA Database entry