Abbott has received the US Food and Drug Administration (FDA) approval for its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN).
Proclaim XR SCS system was previously approved in the US, in 2019, for the treatment of chronic pain.
Current approval expands its indication to include providing relief from chronic pain to DPN patients, who require alternatives to traditional treatment approaches.
Abbott claimed that Proclaim XR SCS system comes with a battery that lasts up to 10 years, while other SCS systems require frequent charging sessions to maintain therapy.
After completion of a minimally invasive trial, patients will be implanted with the Proclaim XR SCS device and can control their therapy through an Apple device.
Pedro Malha, vice president of Abbott’s neuromodulation business, said: “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 diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition.”
DPN is a complication of diabetes, characterised by damage in nerves running to the feet.
Around 50% of adults with diabetes will develop peripheral neuropathy during their lifetime, with symptoms including pain and numbness in the legs, feet, and hands.
Currently, there are no disease-modifying treatments available for DPN, but only symptom management and behavioural modifications to stop further nerve damage due to high glucose levels.
Abbott said that spinal cord stimulation is a non-opioid approach that is proven to be more effective than conventional medical management in the treatment of chronic pain.
People who receive therapy using Proclaim XR SCS system can programme the device using the company’s NeuroSphere Virtual Clinic technology.
Abbott’s NeuroSphere Virtual Clinic is a connected care app that facilitates people to communicate with a physician and receive treatment adjustments remotely.
