FDA Approves Spinal Cord Stimulation System as Alternative Treatment for Diabetic Peripheral Neuropathy

The FDA approved a spinal cord stimulation (SCS) system (Proclaim XR; Abbott) for diabetic peripheral neuropathy (DPN), a condition that currently has no disease modifying treatments. SCS, which is a form of neurostimulation therapy that doses tissue with a certain quantity of energy to relieve pain, can now be added to the available chronic pain management strategies that avoid the use of opioids for patients with DPN.

"[DPN] has long plagued people affected by type 1 and type 2 diabetes, often adding another area of disease management on top of their ongoing monitoring of their glucose levels to manage this challenging disease," said Jason E. Pope, MD, DABPM, FIPP, president of Evolve Restorative Center in Santa Rosa, California, in a press release.

Diabetic neuropathy is a complication that mainly affects the nerves that connect to the feet. There are about 34.2 million (10.5%) people in the United States living with diabetes, and estimates suggest that 50% of these patients will develop DPN.

DPN is caused by high blood sugar (glucose) levels that lead to nerve damage, resulting in pain and numbness in the legs, feet, and hands. While symptom management and behavior modifications aim to manage nerve damage and reduce worsening symptoms, SCS is considered a more effective treatment, despite it being a non-opioid.

The spinal cord stimulation system is implanted in the patient and then managed via an Apple device. The therapy can be used with the NeuroSphere Virtual Clinic app (Abbott) to facilitate communication with physicians and health care providers and receive virtual treatment adjustments.

"[The] spinal cord stimulation system provides patients with painful [DPN] the opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles," Pope said in the press release.

The spinal cord stimulation system was first approved in 2019 to treat patients with chronic pain. This approval by the FDA now provides patients with DPN the ability to receive low doses of stimulation for symptoms contributing to chronic pain.

The new system is also unique because of its 10-year battery life when used for low-dose treatment. Further, patients can work with physicians to adjust system settings anywhere with cellular or Wi-Fi connection and a charged controller.

The safety and dose-response curves of each dose is not clinically established. Patients with DPN who are interested in the SCS system can be referred to a spine surgeon or pain management specialist by their health care provider.

"As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily,” Pedro Malha, vice president, neuromodulation, Abbott, said in the press release. “This new indication for Proclaim XR will drive meaningful change in the treatment of pain associated with diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition."

Reference

FDA APPROVES ABBOTT'S SPINAL CORD STIMULATION FOR PEOPLE LIVING WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY. News Release. January 26, 2023. Accessed January 27, 2023. https://abbott.mediaroom.com/2023-01-26-FDA-Approves-Abbotts-Spinal-Cord-Stimulation-for-People-Living-with-Painful-Diabetic-Peripheral-Neuropathy