FDA green-lights Abbott’s spinal cord stimulator for diabetic neuropathy

By MDLinx staff | Fact-checked by MDLinx staff
Published January 27, 2023

Key Takeaways

  • The FDA has approved Abbott’s Proclaim XR spinal cord stimulation (SCS) system for the indication of diabetic peripheral neuropathy (DPN), a complication of diabetes.

  • SCS systems have been shown to be effective in treating chronic pain in patients with DPN, according to research.

  • Physicians may want to recommend the Proclaim XR system to patients with DPN to help address their pain and improve their quality of life.

A spinal cord stimulation (SCS) system to treat patients with diabetic peripheral neuropathy (DPN) has been approved by the FDA.

The pharmacotherapy device for DPN could represent a significant advancement in the treatment of chronic pain in patients with this condition.

Potential benefits of SCS

An expert spoke to MDLinx about the ways in which SCS systems may benefit patients with DPN.

"If conservative measures (glycemic control and lifestyle changes) do not provide symptomatic relief from diabetic neuropathy, pharmacotherapy remains first-line therapy."

MDLinx contributor Scott Cunningham, MD, PhD

“Among the approximately 50% of patients who do not respond and/or who cannot tolerate pharmacotherapy, spinal cord stimulation is not only effective in approximately 50% of patients who fail pharmacotherapy, but restores nerve function, promotes vascularization, and significantly reduces the need for amputation,” Dr. Cunningham said.

System includes implant, software

The Proclaim XR SCS system was approved on January 26, 2023, according to a press release issued by Abbott, its manufacturer.[]

“Diabetic neuropathy, one of the complications of diabetes, is a type of damage seen predominantly in nerves running to the feet,” the release said. “During their lifetime, approximately 50% of adults with diabetes will develop peripheral neuropathy, which may include symptoms such as pain and numbness in the legs, feet, and hands.”

The Proclaim XR delivers pain relief through low-intensity electrical impulses to a patient’s nerve structures. It uses a rechargeable battery that can run for up to 10 hours at low-dose settings and can last for up to 10 years, according to the press release.

The system will enable patients to control their SCS therapy through an Apple device.

After successfully completing a minimally invasive trial, patients will be implanted with the Proclaim XR device, which can be programmed using Abbott’s proprietary NeuroSphere Virtual Clinic software.

According to the press release, this technology will enable patients to “communicate with physicians, ensure proper settings and functionality, and receive new treatment settings/adjustments remotely, as needed.”

SCS reduces pain, studies show

Research from Chinese investigators published by Neuromodulation studied the performance of SCS in 19 patients with DPN.[]

The authors wrote that “compared with the traditional treatment of DPN, SCS has the advantages of electrical stimulation, including significant analgesia, lower limb blood flow improvement, and improved limb (toe) preservation rate.”

"The VAS pain score is reduced by 50% or higher. This relief is noteworthy."

Zhou, et al., Neuromodulation

Further research published in Neuromodulation on the long-term effects of SCS found that the technology significantly reduced pain in patients with DPN over a course of 8–10 years.[] Investigators found that “for > 50% of patients, the pain reduction was > 30%, which is considered clinically meaningful.”

"SCS can remain an effective treatment in the long term to reduce pain intensity in a subcohort of patients with [painful DPN] who still had an SCS device implanted after 8 years."

Zuidema, et al., Neuromodulation

Previously approved

The Proclaim XR SCS system was previously approved by the FDA to treat chronic pain in 2019, according to a report published by Medical Device Network.[] The approval of the system specifically for DPN is considered a potential breakthrough for patients with DPN as it recognizes the system’s efficacy for this indication.

As there are no disease-modifying treatments available for DPN, symptom management is of paramount importance. Clinicians may want to suggest that patients with DPN consider trying this system to provide relief for their condition.

What this means for you

The Proclaim XR SCS system’s approval for the indication of DPN is noteworthy as it recognizes the system’s efficacy for this specific complication of diabetes. As treatments for DPN target symptom management, this system may be worthy of your consideration to recommend to patients with DPN who seek relief from its chronic pain. Research indicates such systems may significantly improve their well-being and quality of life.

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