This article was submitted by ALPS’ industry partner Nevro.
Recently approved by the FDA with a specific indication for Painful Diabetic Neuropathy, Nevro HFX Spinal Cord Stimulation has been shown to provide people implanted with the device significant pain relief, and for most, a reduction in numbness, tingling, burning and cold sensations.
Spinal cord stimulation (SCS) involves a minimally invasive surgically implanted device that deliver mild electrical pulses to modulate chronic pain pathways. Nevro’s high-frequency 10 kHz Therapy has demonstrated superior pain relief for chronic back and leg pain, and the SENZA PDN RCT showed substantial pain relief for patients with Painful Diabetic Neuropathy (PDN).1,2
Real PDN patient experiences replicate pain relief and improved quality of life results
Jack, HFX patient since 2020: Jack has a passion for car racing and spent much of his life at the track watching his sons race and following NASCAR, IndyCar, and Formula 1. That is, until painful diabetic neuropathy got in the way.
Before Nevro HFX, the pain in his feet made it difficult for Jack to get around the track or even to sleep at night. Jack discovered HFX from a pamphlet found at his pain physician’s office.
Jack was implanted with HFX in January 2020. “I experienced immediate pain relief. I loved that I didn’t have to wait months to find out whether it worked like I did with pain medications,” said Jack. Today, he has 90% less pain and no longer needs to take opioids.
Bill, implanted 2021: “It was like somebody was rubbing coarse sandpaper over my toes whenever anything touched them,” said Bill about the painful diabetic neuropathy he suffered with for 10 years. Before Nevro HFX, Bill would wake up with horrible pain in his back, side and feet that took hours to get over. Fighting a losing battle with pain and managing his symptoms was frustrating and exhausting.
In August 2021, Bill’s pain physician started him on an HFX trial. The following month, Bill had the implant procedure. HFX has brought him about 60% pain relief overall. His mid-back is almost 98% better, his feet are 70% better, and his lower back is 50% improved; “I do experience occasional flare-ups, but the pain is relatively manageable at this point,” said Bill. Today, he can walk farther and cook in the kitchen longer and he has also recently started using an elliptical machine for exercise.
More than 80,000 people worldwide have found long-term pain relief with the Nevro HFX. In July 2021, Nevro’s high-frequency, 10 kHz Therapy received FDA approval for an expanded indication to treat painful diabetic neuropathy. Physicians choose HFX because it’s a safe and clinically proven treatment option that provides relief for more than 80% of people3.
HFX is covered by all major commercial insurance plans including Medicare.
To find a pain physician or neurosurgeon in your area, visit HFXforPDN.com/find-a-physician.
About Painful Diabetic Neuropathy (PDN)
The World Health Organization estimates 422 million adults with diabetes worldwide and prevalence (8.5%) that has nearly doubled over four decades.4 Diabetes may cause systemic damage with profound impact on health-related quality of life and is potentially life-threatening. Diabetic neuropathy is a common complication presenting as pain and other dysesthesias, including numbness, burning, or tingling. Approximately 20% of patients with diabetes will develop PDN, a progressive, potentially debilitating chronic neuropathic pain condition.5 In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that become refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.6,7
- Petersen, E, et. al. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in A Randomized Clinical Trial. JAMA Neurology, April 2021.
- Kapural, L, et. al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery 2016;79:667-677.
- Kapural L, et al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month Results from a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. Published 09 2016
- World Health Organization. (2016). Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
- Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain.2002;18(6):350-354.
- CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain.2002;18(6):350-354.
- Trinity Partners Market Research 2017.