The Food and Drug Administration (FDA) has approved the Proclaim™ XR spinal cord stimulation (SCS) system for the treatment of painful diabetic peripheral neuropathy.
The Proclaim XR SCS system consists of an implantable pulse generator that delivers electrical pulses through leads to nerves along the spinal cord. It was originally approved in 2019 for the treatment of chronic pain.
Clinical studies have shown that SCS treatment in patients with painful diabetic peripheral neuropathy (PDPN) can lead to significant reduction in pain and improved quality of life. When compared with conventional medical treatment alone, the addition of SCS reduced pain more effectively in patients with PDPN in the lower limbs.
Prior to implanting the SCS, a stimulation trial should be performed on a patient to confirm satisfactory pain relief. Patients who successfully complete the trial and undergo implantation of the Proclaim XR SCS device can then control their therapy using an Apple device. The system also pairs with Abbott’s NeuroSphere™ Virtual Clinic, allowing individuals to communicate with a clinician via a secure in-app video chat and receive remote programming adjustments.
Commenting on the expanded approval, Pedro Malha, vice president, neuromodulation, Abbott, said: “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.”
FDA approves Abbott’s spinal cord stimulation for people living with painful diabetic peripheral neuropathy. News release. January 26, 2023. https://www.prnewswire.com/news-releases/fda-approves-abbotts-spinal-cord-stimulation-for-people-living-with-painful-diabetic-peripheral-neuropathy-301731127.html