FDA Approves Proclaim XR Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy

This article was originally published on NeurologyLive.com.

The FDA has approved the Proclaim XR spinal cord stimulation (SCS) system for the treatment of painful diabetic peripheral neuropathy (DPN), according to an announcement from Abbott.¹ The company noted the system offers alternative options for those patients receiving other medications.

Jason E Pope, MD, DABPM, FIPP

The system was previously approved in 2019 for the treatment of chronic pain. After a minimally invasive trial and the device implantation, patients can then control their therapy via an Apple device. Abbott also noted in its announcement that individuals who receive therapy from the Proclaim XR SCS system will have access to the company’s NeuroSphere Virtual Clinic, a connected care app that allows for patient-physician communication and remote treatment adjustments via cellular or Wi-Fi connection.

Notably, the list of available disease-modifying therapeutics for DPN is blank. With only symptomatic and behavioral avenues for disease management, there is great need for more treatment approaches to improve patient care.² Additionally, the population of individuals with diabetes is large—an estimated 34 million people in the United States—and approximately 50% of adults with diabetes develop peripheral neuropathy, often leading to symptoms including pain and numbness in the extremities.^3,4

Jason E Pope, MD, DABPM, FIPP, president of Evolve Restorative Center in Santa Rosa, California, said in a statement,¹ "Diabetic peripheral neuropathy has long plagued people affected by type 1 and type 2 diabetes, often adding another area of disease management on top of their ongoing monitoring of their glucose levels to manage this challenging disease. Abbott's Proclaim XR spinal cord stimulation system provides patients with painful diabetic peripheral neuropathy the opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles."

In a prospective open-label trial (NCT01162993) conducted by Maastricht University Medical Center, in Maastricht, the Netherlands, trial stimulation was successful in 77% of the SCS patients after they were randomly assigned to SCS in combination with the best medical treatment (BMT) (n = 22) or to BMT only (n = 14).⁵ Treatment success, defined as at least 50% pain relief during daytime or nighttime or a response of "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 6 months, was observed in 59% of the SCS group and in 7% of the BMT group (P <.01).

Daytime pain relief and nighttime pain relief were reported by 41% and 36% of the SCS group, and 0% and 7% of the BMT group, respectively (P <.05). Likewise, pain and sleep were noted as "(very) much improved" by 55% and 36% of the SCS group, whereas the BMT group reported no changes in either, respectively (pain, P <.001; sleep, P <.05). The study authors concluded that, “Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.”

In another multicenter trial that also randomly assigned patients with DPN (n = 60) in a 2:1 ratio to SCS with BMT or BMT alone, the average visual analogue scale (VAS) score for pain intensity was 73 in the SCS group and 67 in the BMT group at baseline. After 6 months, the average VAS score was reduced to 31 in the SCS group (P <.001) and remained at 67 (P = .97) in the control group.⁶

"As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily. 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," Pedro Malha, the vice president of neuromodulation at Abbott, said in a statement.¹

REFERENCES
1. FDA Approves Abbott's Spinal Cord Stimulation for People Living with Painful Diabetic Peripheral Neuropathy. News release. Abbott. January 26, 2023. Accessed January 26, 2023. https://prnmedia.prnewswire.com/news-releases/fda-approves-abbotts-spinal-cord-stimulation-for-people-living-with-painful-diabetic-peripheral-neuropathy-301731127.html
2. Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Current Diabetes Reports.2019;19(10):86. doi:10.1007/s11892-019-1212-8
3. Cernea S, Raz I. Management of diabetic neuropathy. Metabolism. 2021;123:154867. doi:10.1016/j.metabol.2021.154867
4. Feldman EL, Callaghan BC, Pop-Busui R, et al. Diabetic neuropathy. Nat Rev Dis Primers. 2019;5(1):42. doi:10.1038/s41572-019-0097-9
5. Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016-24. doi:10.2337/dc14-0684?
6. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial. Pain. 2014;155(11):2426-31. doi:10.1016/j.pain.2014.08.031