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FDA Approves Abbott's Spinal Cord Stimulation for Diabetic Peripheral Neuropathy

Friday, January 27, 2023

Abbott announced that the U.S. 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 provides relief to DPN patients who are in need of alternatives to traditional treatment approaches, such as oral medication. 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. 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.

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 blood sugar (glucose) levels. Spinal cord stimulation is a non-opioid approach currently being used for more than 50 years to help manage chronic pain and is proven to be more effective than conventional medical management in the treatment of this type of chronic pain.