FDA approves Abbott’s spinal cord stimulation system for those with painful diabetic peripheral neuropathy


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, say Abbott. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott’s NeuroSphere Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.

Approved for the treatment of chronic pain in 2019, the Proclaim XR SCS system now offers DPN patients relief from chronic pain by delivering low amounts, or doses, of stimulation.

Jason Pope, MD, president of Evolve Restorative Center (Santa Rosa, USA), said: “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. Abbott’s Proclaim XR SCS system provides patients with painful DPN the opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles.”

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


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