Abbott's spinal cord stimulator nets FDA green light for diabetes pain

Pain comes in many forms, and Abbott aims to treat as many as it can with its devices. The company received a new approval from the FDA for its low-dose spinal cord stimulator implant, covering peripheral neuropathy caused by diabetes.

Abbott estimates that about half of the 34 million people in the U.S. with Type 1 or Type 2 diabetes will develop the complication, typically caused by nerve damage that brings pain and numbness in the legs, feet and hands.

While the condition doesn’t have a direct treatment, the company said it hopes its Proclaim XR hardware can offer patients an option for managing symptoms outside of oral painkiller medications.

The Proclaim XR was first approved for chronic pain in 2019, with a battery that lasts up to 10 years when set at a relatively low dose compared to other spinal cord stimulators. The device delivers small, patterned amounts of electricity to the spinal cord, with mild bursts designed to disrupt pain signals as they cross nerves on their way to the brain.

The system can also be controlled with an Apple iPhone or iPad, through Abbott’s NeuroSphere Virtual Clinic app, which can connect the user with clinicians and help review and alter treatment settings remotely.

The new approval will put up the Proclaim XR against Medtronic’s Intellis and Vanta stimulators, which obtained the FDA’s blessings in diabetic neuropathy in January 2022. Last year also saw the agency approve a wearable neurostimulator from DyAnsys, placed behind the ear, for a significantly less invasive approach.

Abbott collected multiple FDA green lights for its neurostimulator portfolio last year, including its Proclaim Plus device designed to treat chronic pain in up to six areas of the body at once. With a 10-year battery life, it sends out low-dose electrical pulses similar to the Proclaim XR.

When it comes to rechargeable devices, Abbott launched one of its smallest implants last December. The Eterna is implanted near the spinal cord with a battery that can be topped off wirelessly, either for one hour per month or through three-hour sessions five times a year.