![]() No other SCS treatment for PDN has exhibited the potentially disease-modifying effects demonstrated by Nevro HFX™ in improving neurological function. ![]() A majority of these neurological improvements were in sensory function, which may have implications in restoring protective sensation. At 24 months, 65.7% of implanted patients exhibited clinically meaningful improvements over study baseline in sensory, motor, or reflex function without worsening in any category. Investigators assessed neurological function versus study baseline in all implanted patients.In the 10 kHz SCS recipients, the proportion with a DN4 score <4 increased significantly from 3.9% at preimplantation to 48.9% at 24 months. A DN4 score ≥4 is consistent with clinically confirmed PDN.At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief.The SENZA-PDN RCT 24-month data demonstrated the following benefits of 10 kHz SCS Therapy: "These results further validate not only the efficacy of high-frequency 10 kHz SCS for pain relief, but also show profound improvements in quality of life, sleep, and neurological function." Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. "The 24-month data from the SENZA-PDN RCT show us high-frequency SCS is a viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time," said lead Principal Investigator Dr. The long-term data further supports that 10 kHz SCS is a safe and highly effective therapy for PDN, as well as a therapy that demonstrates durable quality of life improvements. The data show that patients who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM), compared to CMM alone, experienced durable pain relief and significant improvements in both HRQoL and sleep at 24 months post-implantation.įurthermore, most participants experienced neurological symptom improvements, including those in motor, sensory, and reflex function. Published 24-month data from the SENZA-PDN RCT evaluated the long-term efficacy of high-frequency 10 kHz SCS to treat refractory PDN. 3 As a result, people with PDN suffer significantly-reduced health-related quality of life (HRQoL), impaired functionality, and other comorbidities like sleep disorders, depression, and anxiety. 2 Patients typically manage this complication with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects for patients. These symptoms include numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli. PDN symptoms can have a significant impact on quality of life. Globally, the number of people with diabetes has quadrupled in the last two decades 1, and PDN is one of its most common complications, affecting up to 25 percent of all people with diabetes.
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