FDA Approves New Implantable Device to Treat Pain From Diabetic Nerve Damage
The FDA approved Proclaim XR, a new implantable spinal cord stimulation device, as a treatment for pain from diabetes-related nerve damage, which affects 1 in 3 people with diabetes.
On Jan. 26, Abbott announced that the FDA approved its spinal cord stimulation system (SCS), Proclaim XR, as a treatment for pain from diabetic neuropathy, or diabetes-related nerve damage.
SCS systems, sometimes referred to as neurostimulators, are fully implantable devices (implanted through an outpatient surgical procedure) that deliver small vibrations or stimulations to the spine. This works to stop pain signals before they reach the brain, reducing the painful symptoms of neuropathy.
Diabetic peripheral neuropathy (DPN), a complication that affects approximately 1 in 3 people with diabetes, happens when high glucose levels damage nerves in the extremities (the hands, legs, or feet.) Many people describe the symptoms of DPN as numbness, tingling, or burning sensations that start at the toes or fingers and move upward. This initial sensation may develop from mild to severe pain.
People with diabetes who have DPN are at greater risk of amputation as they may experience wounds that do not heal. This is especially true for those who have peripheral arterial disease, an infection of the legs, or foot ulcers that go unnoticed.
Treatments for DPN have previously focused on managing glucose levels and improving time in range. Medications are also available to address painful DPN. However, these medications often cannot be used long-term and may come with several, unpleasant side effects. Neurostimulators are an alternative option for painful DPN with hopefully longer-lasting pain relief and fewer side effects.
In recent years, advancements in SCS technology have led to the approval of several neurostimulators in addition to Proclaim XR, including implantable devices from Medtronic and Nevro, and a non-invasive device developed by DyAnsys.
Clinical studies showed that Proclaim XR helped limit the psychological impact of chronic pain, and using the device led to significant improvements in participants’ physical, mental, and emotional function.
Proclaim XR was initially approved by the FDA in 2019 as a treatment for chronic pain. The new indication now allows people with painful DPN to access the device, which is available now. Those who are experiencing pain from DPN should talk with their healthcare provider about a referral to a spine surgeon or pain management specialist, who can implant the neurostimulator.
“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," said Pedro Malha, vice president, neuromodulation at Abbott, in the company’s latest press release.
Once the device has been implanted, the user and their healthcare provider can connect to it through the NeuroSphere Virtual Clinic. NeuroSphere, which is available on iOS smartphones through the App store, allows users to communicate with their healthcare provider to make treatment adjustments, without the need for a visit to the specialist.
For more about neurostimulators and treatments for diabetic neuropathy, see: