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Home » FDA approves Abbott’s spinal cord stimulation system for diabetic peripheral neuropathy

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

January 26, 2023 By Sean Whooley

Abbott Proclaim XR spinal cord stimulation painful diabetic neuropathy
The Proclaim XR spinal cord stimulation system. [Image courtesy of Abbott]
Abbott (NYSE:ABT) announced today that the FDA approved its spinal cord stimulation system for treating painful diabetic peripheral neuropathy (DPN).

The Proclaim XR SCS system offers relief to patients with DPN, a debilitating complication of diabetes. These patients need alternatives to traditional treatment approaches like oral medication. Users of Proclaim XR can also use Abbott’s NeuroSphere virtual clinic.

NeuroSphere, a connected care app, allows people to communicate with a physician and receive treatment adjustments remotely.

Currently, no disease-modifying treatments for DPN exist, Abbott said in a news release. Patients can only receive symptom management and behavioral modifications to mitigate further nerve damage from high glucose levels.

Proclaim XR initially received FDA approval for treating chronic pain in 2019. It now offers DPN patients relief from chronic pain through low doses of stimulation. The battery lasts up to 10 years at low-dose settings, too.

Abbott’s SCS offers better quality of life, doctor says

Dr. Jason Pope, president of Evolve Restorative Center in Santa Rosa, California, said the system offers an “opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles.”

Abbott conducted a successful minimally invasive trial for Proclaim XR in tandem with Apple devices. Users can now control their therapy through the Apple device. They can also program the device using the NeuroSphere technology.

“As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily,” said Pedro Malha, VP of neuromodulation at Abbott. “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.”

Filed Under: Business/Financial News, Diabetes, Featured, Food & Drug Administration (FDA), Implants, Neuromodulation/Neurostimulation, News Well, Pain Management, Regulatory/Compliance Tagged With: Abbott, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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