Abbott gains US FDA approval for SCS therapy in painful diabetic neuropathy patients


Abbott has announced that the US Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN)—a debilitating complication of diabetes.

The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication, according to an Abbott press release. People who receive therapy from the Proclaim XR SCS system will also be able to use the company’s NeuroSphere virtual clinic—a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.

Currently, there are no disease modifying treatments for DPN; only symptom management and behavioural modifications to mitigate further nerve damage that can result from high glucose levels, Abbott claims. SCS constitutes a non-opioid approach that has been used for more than 50 years to help manage chronic pain and—according to the release—is proven to be more effective than conventional medical management in the treatment of this type of chronic pain.

Having been approved for the treatment of chronic pain in 2019, the Proclaim XR SCS system now offers DPN patients relief by delivering low doses of electrical stimulation. Unlike other SCS systems that require frequent charging sessions to maintain therapy, the Proclaim XR SCS system provides hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings, Abbott also claims.

“Diabetic peripheral neuropathy 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 Pope (Evolve Restorative Center, Santa Rosa, USA). ”Abbott’s Proclaim XR spinal cord stimulation system provides patients with painful diabetic peripheral neuropathy the opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles.”


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