There is now a new way to treat painful diabetic neuropathy, with a novel technology that sends electrical pulses into the lower spinal cord to make the pain go away, but without causing any tingling or other side effects.
Northern California-based medical device company Nevro Corp. has developed high-frequency spinal cord stimulation technology that could revolutionize treatment of painful
DPN is one of the more challenging diabetes complications to address, as traditional treatments struggle to target the right areas on the body and remain effective over time.
Nevro announced on July 19, 2021, that the Food and Drug Administration (FDA) had cleared its system called Senza (aka “HFX”) for use with PDN, about seven months after the company submitted it to regulators. This comes after Nevro presented new data at the American Diabetes Association’s 81st Scientific Sessions in June, from research they described as the largest-ever randomized clinical study assessing spinal cord stimulation for diabetes neuropathy.
This technology is now the first and only FDA-approved, drug-free, implantable device to effectively treat this type of chronic pain.
What this means is that for some PWDs, the crippling pain could finally stop. They could finally once again feel sensations that are important to keeping them safe, like stepping on a pebble, or the wet tiles in a shower, or being able to use car pedals without fear of getting into an accident due to the lack of sensation in the lower limbs.
By Nevro’s own estimates based on published literature it cites, there are approximately 4 million PWDs living with painful diabetic neuropathy in the United States.
In a nutshell, DPN is damage to the peripheral nervous system, the vast communication network that sends signals between the central nervous system (the brain and spinal cord) and all other parts of the body, according to the
Peripheral nerves serve to send sensory information to the central nervous system, such as a message that your feet are cold, or pain to let you know injury is occurring. They also carry signals that tell your muscles to contract and to help control everything from our hearts and blood vessels to digestion, urination, sexual function, bones, and immune system.
With DPN, these signals are disrupted and people experience shooting pains and uncomfortable sensations in their lower limbs called paresthesias, such as numbness, tingling, burning, or prickling.
Traditional treatments include anti-seizure drugs like Pregabalin (brand name Lyrica) and Gabapentin (Gralise, Neurontin). In 2017, the American Diabetes Association (ADA) issued a position statement discouraging the use of opioids to treat nerve pain, while recommending two specific medications — Lyrica and duloxetine (Cymbalta) — despite the potential side effects like weight gain, sleepiness, and lack of focus. Alternative treatments include ointments containing antioxidents and nutrients to treat neuropathy pain.
But all of those options have drawbacks, like side effects and general ineffectivity.
There are some newer devices that use electrical impulses to help prevent pain signals from reaching the brain, notably a mobile device called Quell. But unlike spinal cord stimulation, that tech targets nerve endings where the pain is experienced, so it’s not particularly useful if you’re experiencing neuropathy pain in more than one place.
That’s where Nevro’s promise comes into the picture.
While conventional spinal cord stimulators have been around for decades, Nevro’s innovative core technology known as “HFX” uses a higher frequency: 10 kHz. This has been available in the United States since 2015 and internationally for a decade, but it’s never before been labeled to specifically treat PDN.
The Senza system uses this high-frequency proprietary waveform that’s designed to give you wide-reaching paresthesia-free pain relief, irrespective of your body position.
It’s a small square device that’s implanted into your body, near the lower part of your spine. It transmits mild electrical pulses to the spinal cord as needed, for pain that might be felt in the legs, feet, toes, or arms. Those pulses calm the nerves and reduce pain signals to the brain.
You’d go to a doctor’s office or the hospital for a small surgical procedure in which the unit and its thin flexible wires are placed beneath the skin next to your spine. It comes with a remote control unit that lets you control and adjust the spinal cord stimulation levels as needed for the pain. Nevro says that “16 contacts provide the broadest possible coverage and allow a range of programming options.”
The HFX device has a battery that lasts up to 10 years, while the handheld receiver used to start the pulses generally needs recharging every day or so.
Studies show that the system is safe and also doesn’t interfere with one’s normal sensory perception, cognitive abilities, or motor functions. It can also be easily removed if it isn’t working or isn’t needed any longer.
“No traditional, low-frequency spinal cord stimulation treatments have demonstrated such positive results in treating neuropathy patients,” said Nevro CEO and President D. Keith Grossman. “We believe there’s a significant opportunity to expand this innovative treatment option to patients who are unable to find relief with currently available pharmacologic options.”
Dr. Erika Petersen, director of the Section of Functional and Restorative Neurosurgery at University of Arkansas Medical School in Little Rock, gave a presentation at #ADA2021 on the latest research around this Nevro neuropathy treatment.
“10 kHz spinal cord stimulation shows a durable impact on pain maintained to 12 months,” she said.
Overall, those using the Nevro tech during a 12-month period experienced swift improvements in their lower limb pain and how that interfered with their daily routines and sleep quality.
The study included 216 patients placed in either high-frequency spinal cord stimulation plus standard medical management, or standard medical management alone. Those in the clinical trial needed to have diabetes-related neuropathy for at least a year, a certain level of lower limb pain, and a current A1C level of 10 percent or higher.
Per the study, success was determined to be at least a 50 percent reduction in neuropathy pain. By that definition, Nevro’s technology worked well. Outcomes in the study looked at changes in pain, neurological function, and quality of life.
Remarkably, the study data showed that 82 percent of participants saw a reduction in painful neuropathy symptoms after the first 6 months of use.
The study “demonstrated clear, sustained benefits… in regard to lower limb pain, pain interference with daily living, sleep quality, and activity. Additionally, patients receiving spinal cord stimulation appear to have improvements of neurological function during examinations.”
This added to
In a telling statistic, patients had the chance to crossover from one arm of the study after 6 months, and 82 percent chose to use the Nevro tech. But no one opted to go from the implant to conventional meds.
Dr. Lisa Brooks, principal clinical research scientist at Nevro, says that many PWDs stop using neuropathy pain medications like Lyrica or Neurontin for a variety of reasons. Commonly, it’s because the meds stop working as effectively or the patients would rather deal with the pain than side effects like swelling, sleepiness, fogginess, and even depression in certain instances.
Brooks told DiabetesMine that their clinical trial participants often reported incredible relief for the first time after using the Nevro technology.
“Patients would come back to their physician and report that they could feel their feet again,” she said. “They’d say things like they could feel the wet tiles in the shower again, or ‘I stepped on a sharp Lego and could feel that.’ ‘My feet feel normal,’ they’d say, and they haven’t felt that way in years.”
Nevro told DiabetesMine in early July that it planned to launch the technology as soon as it gets FDA clearance.
The says it has been negotiating with insurance companies to work out coverage specifics of this new application of spinal cord stimulation for DPN.
According to marketing director Meredith Vornholt, Medicare and private insurance companies generally do cover spinal cord stimulation very well. The out-of-pocket cost can be significant at $7,000 to 10,000, but with insurance coverage, copays are much lower. Often, there may be a 20 percent coinsurance according to some estimates.
To learn more about possibly starting on this new HFX for PDN treatment, visit Nevro’s website, where you can answer some basic questions and submit your contact information to explore eligibility.