FDA Clears Spinal Cord Stimulator for Diabetic Neuropathy

The US Food and Drug Administration has approved Abbott’s Proclaim XR spinal cord stimulation (SCS) system for the treatment of patients with diabetic peripheral neuropathy (DPN), the company announced today.

As previously reported by Medscape Medical News, the FDA originally approved the system for patients with chronic pain in 2019. The device uses the company’s proprietary low-energy BurstDR stimulation waveform combined with a protocol that provides effective pain relief with lower doses of stimulation, significantly extending the system’s battery life.

Diabetic neuropathy is the most common side effect of diabetes, affecting as many as half of patients with the condition. There are currently no disease-modifying therapies for DPN, only symptom management and behavioral modifications to mitigate further nerve damage.

“The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication,” the company notes in a press release.

The system delivers low-intensity electrical impulses to nerve structures and includes a battery that lasts up to 10 hours without recharging when used at low-dose settings.

The Proclaim XR system was originally approved based on positive results from the BOLD study, in which all 24 enrolled patients on a low-energy BurstDR dosing program saw pain relief with < 6 hours of battery use per day. About half of those patients achieved pain relief with the lowest effective dose (< 2 hours of daily battery use).

“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 E. Pope, MD, president of Evolve Restorative Center in Santa Rosa, California, said in the company release.

“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,” he added.

Following implantation of the device, patients will have the ability to control their therapy through an Apple device. Patients can also access the manufacturer’s NeuroSphere Virtual Clinic through their mobile device, which allows them to communicate with their clinician and receive remote adjustments to their therapeutic settings as needed.

Kelli Whitlock Burton is a reporter for Medscape Medical News covering neurology and psychiatry.

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