2-Year Data Supports Nevro Spinal Cord Stimulation for Diabetic Neuropathy

Nevro has released publication of 24-month data from its 216-patient SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), which according to the chronic pain treatment firm is the largest RCT to evaluate spinal cord stimulation (SCS) to treat PDN.
 
The SENZA-PDN RCT trial published 24-month data assessed long-term efficacy of high-frequency 10 kHz SCS to treat refractory PDN. The data revealed patient receiving a high-frequency 10kHz implant and conventional medical management (CMM) compared to CMM alone had “durable pain relief” and “significant improvements” in HRQoL (health-related quality of life) and sleep at 24 months after implantation.
 
The data showed that most participants also had neurological symptom improvements, including motor, sensory, and reflex functions. The long-term data support 10 kHz SCS as a safe, effective therapy for PDN with durable quality of life improvements.
 
“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,” lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, told the press. “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.”
 
At 24 months, 10 kHz SCS reduced pain by an average 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. 65.7% of implanted patients showed “clinically meaningful” improvements over study baseline in sensory, motor, or reflex function without worsening in any category.
 
HRQoL improved with 10 kHz SCS, based on the EuroQol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire. Treatment with 10 kHz SCS significantly reduced pain interference with sleep in the group of all implanted patients over 24 months, shown by a 65.5% decrease in the average PSQ-3 score, from 6.5 at preimplantation to 1.9 at 24 months.
 
“We’re encouraged by the latest data demonstrating the long-term efficacy of Nevro HFX to treat the millions of people suffering from PDN worldwide,” said Dr. David Caraway, Nevro’s chief medical officer. “Compared to previous studies evaluating traditional low-frequency systems for these patients, high-frequency 10 kHz SCS demonstrated greater pain reduction and higher responder rates over time.5 As we continue gathering data, we expect these results to be used in physician referral decisions and continue to support market access for high-frequency SCS for PDN patients.”