(BPT) - The pain was so bad, James Smith couldn’t sleep. With what felt like a thousand bees stinging his legs, he spent hours at the computer searching for: “Treatment options for painful diabetic neuropathy (PDN).”
“When I couldn’t sleep, I’d find myself searching online,” said Smith. “I wanted to try something safe to control my pain, and preferably not a drug. Every day I wished I could live my life the way I used to.”
Since his diabetes diagnosis, Smith's numbers were under control, but this was different — the newly developed leg pain made normal activities like walking, gardening, sitting and sleeping almost intolerable. Something had to change. Then, a Facebook ad for a clinical trial led him to HFX for PDN,* a new device to help treat painful diabetic neuropathy.
In July 2021, Nevro became the first company to receive FDA approval of a spinal cord stimulation (SCS) system for the treatment of PDN. The approval of HFX for PDN (which includes all Nevro Senza Systems) followed the successful completion of the randomized clinical trial in which Smith participated. This was the largest-scale study to date by a company establishing evidence for the safety and efficacy of SCS to treat PDN.
“I was not very hopeful when I first enrolled in the clinical trial. I was in so much pain, doing basic things felt impossible,” said Smith. “My doctor told me we’d know soon after my initial test with the technology if I’d be a candidate for the implant. Then I was amazed by how quickly I felt relief. This device changed my life.”
Diabetes and painful diabetic neuropathy
About 10.5% of the U.S. population, or 34.2 million people, have diabetes. While there are many complications associated with the condition, diabetic neuropathy is the most prevalent and chronic complication. PDN most often damages nerves in legs and feet.
Although each person may experience it differently, the symptoms of PDN are often worse at night, and may include:
- Tingling, burning or freezing sensation
- Sharp stabbing, shooting pains or cramps
- Hypersensitivity to touch — even a bedsheet's weight can be painful
- A deep, persistent ache
As reported in an FDA patient panel, people with PDN often have trouble achieving pain relief. Once diagnosed, it is typical to try standard treatment options such as physical therapy, injections, over-the-counter medications and prescription medications including opioids. Opioids are used to manage chronic pain in the U.S., but their addiction potential can lead to long-term dependence and show little evidence of improving function. In academic and medical communities, opioids are referenced as a last resort for treating PDN.
Prior to learning about the new treatment, Smith's chronic pain meant missing out on participating in his daughter’s wedding. Standing and participating in a ceremony may not seem daunting for some, but people living with PDN often miss life’s most precious moments. New options for patients were needed.
New treatment, new day
Nevro’s HFX for PDN provides an alternative to conventional therapies, using Spinal Cord Stimulation (SCS): mild electrical pulses to disrupt pain signals before they reach the brain.
HFX for PDN is currently the only SCS system with an FDA indication to treat PDN. Unlike other systems, its proprietary, high-frequency 10 kHz waveform doesn’t rely on an uncomfortable tingling sensation (known as paresthesia) to override pain. By “tricking” the brain, patients experience pain relief — allowing them to pursue activities they enjoy and live independently.
Rather than long-term therapy and unwanted side effects, HFX for PDN provides an exciting new option through a quick, minimally invasive procedure to implant a small device under the skin near the spine.
For doctors and patients, HFX for PDN provides versatility for optimal chronic pain relief. The HFX system now delivers more versatility, without in-person visits, and patients can access innovative technologies, advanced therapies and patient support through a dedicated HFX Coach.
“Our PDN study showed that HFX and 10 kHz Therapy can help so many people suffering from PDN,” said Dr. Cong Yu of Swedish Pain Services in Seattle. “HFX for PDN can reduce patients’ medication use, likely preventing deterioration of their pain condition.”
To learn more about new treatments for painful diabetic neuropathy, visit HFXForPDN.com.
*HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. HFX for PDN means that a patient has been implanted with a Senza System and programmed to include a frequency of 10 kHz.