Two-Year Study Shows Nevro’s High-Frequency Neurostimulation Reduces Diabetic Neuropathy Pain by 80%

Nevro’s high-frequency neurostimulation system, after being granted FDA approval as the pioneering spinal cord stimulator to alleviate diabetic neuropathy pain, has received robust validation through an extensive long-term study. This comprehensive investigation, spanning two years and involving over 200 individuals grappling with painful diabetic neuropathy, has been recently published in the esteemed Diabetes Research and Clinical Practice journal, with the company announcing these findings on a recent Wednesday.

During the course of this comprehensive study, 142 participants underwent the implantation of Nevro’s sophisticated high-frequency Senza system. This system, strategically positioned in proximity to the spinal cord, operates at an impressive 10 kHz frequency, generating 10,000 electrical pulses per second within the patient’s nervous system. The core intent of this process is to disrupt the transmission of pain signals en route to the brain. It is important to note that the frequency harnessed by Nevro’s innovation supersedes that of numerous analogous spinal cord stimulators presently available in the market. Furthermore, Nevro asserts that their high-frequency methodology effectively eliminates the often-unpleasant sensations of tingling and buzzing commonly associated with the use of lower-frequency neurostimulation approaches. The Senza system boasts a pioneering rechargeable design and is accompanied by a battery life projection of up to a decade.

Nevro’s data indicates that approximately 25% of individuals diagnosed with diabetes suffer from diabetic neuropathy. This condition materializes through an array of distressing symptoms including numbness, tingling, compromised balance, and a reduced responsiveness to sensory stimuli. The conventional approach to managing these symptoms primarily involves the administration of oral pain-relieving medications. Unfortunately, these interventions frequently yield suboptimal results and, in certain instances, provoke adverse reactions that further exacerbate the already challenging experiences of patients.

At the conclusion of the rigorous 24-month study, recipients of the Senza system witnessed an impressive average reduction in pain levels of nearly 80%. Remarkably, over 90% of the study participants experienced a substantial minimum reduction of 50% in their pain levels following the implantation of this groundbreaking neurostimulation device. Extending beyond the relief of pain, Nevro’s technological advancement markedly improved the overall quality of life of participants in terms of health-related parameters. On the meticulously calibrated EuroQol 5-Dimension 5-Level scale, individuals who received the implants demonstrated an average improvement of 0.146—an enhancement three to five times greater than the specified minimal important distinction for individuals grappling with Type 2 diabetes.

As the study concluded, an estimated two-thirds of the participants displayed statistically significant enhancements in comparison to their baseline neurological performance. A substantial majority of these improvements centered around sensory functions, suggesting that Nevro’s inventive technology has the potential to reinstate protective sensory responses in individuals wrestling with the complexities of painful diabetic neuropathy.

During the two-year investigation, only a minor 3% of the Senza systems necessitated removal due to infection, as officially communicated by the company. Encouragingly, none of these removals were attributed to any malfunction or technical flaws inherent to the device itself. The convergence of these data strongly suggests that Nevro’s high-frequency Senza system establishes itself as a durable, viable solution for individuals burdened by the challenges of painful diabetic neuropathy.

Dr. David Caraway, a prominent medical figure occupying the role of Nevro’s Chief Medical Officer anticipates that these promising results, when coupled with forthcoming studies of a similar nature, will significantly augment the volume of referrals by physicians for Nevro’s pioneering therapy.

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