Abbott Laboratories, a multinational medical devices firm based near Chicago, has announced that the U.S. Food and Drug Administration (FDA) has approved its spinal cord stimulation (SCS) system for treating diabetic peripheral neuropathy (DPN), a painful condition that, by some estimates, affects roughly half of people with diabetes in the United States.
Spinal cord stimulation has been around since the late 1960s, and the science behind it has evolved as new battery technology has come along and the number of conditions in which SCS can be utilized has increased. SCS has been used for Parkinson’s disease, angina, pain relief, increasing blood flow, and other applications. The new Abbott device, which is known as the Proclaim XR SCS System, was approved for the treatment of chronic pain in 2019, but the new FDA ruling now enables physicians to prescribe it specifically for DPN, which normally manifests itself as uncomfortable sensations (throbbing, burning, numbness, and so on) in the feet and hands.
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The Proclaim XR SCS System
Several prescription drugs (such as pregabalin, gabapentin, and various antidepressants), are available to treat diabetic nerve pain, but not everyone responds to them, and some experience disagreeable side effects. Proclaim XR, the company says, provides an alternative to the use of drugs in the treatment of DPN. The device, they state, is distinguished from other SCS systems by, first, its battery capabilities. Other systems, the company says, need repeated battery charging sessions, but Proclaim XR uses a battery that can last as long as 10 years when used at low-dose settings. Second, Abbott says its technology differs from traditional neurostimulation by employing what the company calls “BurstDR stimulation,” which “works by mimicking natural patterns found in the brain — modifying pain signals and changing the way your body perceives pain,” as Abbott puts it.
Abbott offers prospective users a trial period during which they can evaluate the effectiveness of the technology before undergoing an implantation. The trial period can be a few days or a few weeks. Patient assessments include such issues as real pain relief, a greater ability to perform daily activities, and sleep improvement. A pain reduction of 50% is generally considered adequate success.
Once patients choose to proceed with implantation, their physician usually refers them to a pain management specialist or a spine surgeon. Placing the leads is a procedure that uses general anesthesia and, like any such surgical procedure, does have its risks. Implanting the device takes one to two hours, and once it’s implanted, patients will have the ability to control their therapy through an Apple software technology called the NeuroSphere Patient Controller App, which is used on Apple iPhones. Users in the United States also have access to Abbott’s Virtual Clinic, a remote patient care technology that lets patients communicate with physicians to make sure the settings are correct and even to receive new settings remotely if they’re required.
Spinal cord implantation can be costly, but Abbott says both the trial period and the actual implantation are normally covered by most major insurance plans, Medicare, and workers’ compensation programs. As the company puts it, “You will need to work with your doctor’s office and insurance company to determine your coverage.”
Want to learn more about neuropathy? Read “Coping With Painful Neuropathy,” “Diabetic Neuropathy,” and “Controlling Neuropathic Pain.”
