The Food and Drug Administration (FDA) has approved Medtronic’s Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for the treatment of pain associated with diabetic peripheral neuropathy (DPN).
These implantable spinal cord stimulation (SCS) devices were cleared based on data from a randomized controlled trial published in the journal Diabetes Care in 2014. The study included 36 patients with painful DPN who were not responding to conventional therapy. Patients were randomly assigned to receive SCS in combination with best medical treatment (BMT; n=22) or BMT alone (n=14).
Results showed that over a 6-month period, daytime pain relief was reported in 41% of patients in the SCS group and 0% of patients in the BMT group (P >.05), while nighttime pain relief was observed in 36% of patients receiving SCS and 7% receiving BMT (P >.05). In the SCS group, pain and sleep were “very much improved” in 55% and 36% of patients, respectively; no changes were noted in the BMT group for these endpoints.
The Company also included data from several independent studies to support SCS use in DPN patients.
In 2020, the FDA issued a letter to health care providers concerning the use of SCS devices. The Agency’s recommendations included a reminder that a stimulation trial should be performed to confirm satisfactory pain relief before permanent SCS implantation takes place.
- Medtronic announces FDA approval of spinal cord stimulation therapy for treating chronic pain resulting from diabetic peripheral neuropathy. News release. Medtronic. Accessed January 24, 2022. https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems/vanta-pc-neurostimulator.html
- Slangen, R. Schaper, N.C. Faber, C.G. Joosten, E.A. Dirksen, C.D. van Dongen, R.T. et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 2014 Nov;37(11):3016-24. doi:10.2337/dc14-0684.