PENS: Treating Diabetic Nerve Damage Without Surgery or Implants
A new device cleared by the FDA called a percutaneous electrical nerve field stimulator – or PENS, for short – can reduce nerve pain without the need for surgery.
Diabetic neuropathy is a serious complication of diabetes that occurs when high glucose levels damage the nerves in the extremities, such as the hands, legs, and feet. This can lead to varying levels of pain, ranging from a mild tingling or numbness to severe, stabbing pains.
Previously, treatments were limited to pain medications, which sometimes had unpleasant side effects. A newer technology called a spinal cord stimulator or neurostimulator, a type of implantable device, is another treatment option with fewer side effects and longer-lasting relief than pain medications. Neurostimulators work by generating small electrical impulses that block the body’s pain signals from reaching the brain. While the devices do not treat the underlying cause of neuropathy, they can lead to significant pain relief for many with the condition. The FDA has cleared several spinal cord stimulators in recent years, including devices by Abbott, Medtronic, and Nevro.
Up until now, spinal cord stimulators had to be implanted under the skin, which requires a visit to the clinic for an outpatient surgical procedure. As it's considered a minor surgery, neurostimulators carry certain risks and may not be appropriate for every person. But a new device called First Relief, developed by the biotechnology company DyAnsys, offers a less invasive approach.
First Relief was cleared by the FDA in July 2022 as a treatment for pain caused by diabetes-related nerve damage. Unlike other spinal cord stimulators, this “neurostimulator” sits on the skin just behind the ear and does not require surgical implantation. The device features three small, acupuncture-like needles that reach just under the skin, which put out small electrical impulses over several days. The FDA has cleared the device for several multi-day treatments for up to eight weeks.
In a clinical trial of First Relief, 63 participants with diabetes-related nerve pain reported significant reductions in pain. This pain reduction lasted through the 90-day follow-up after the trial, demonstrating that the device could have long-lasting effects on pain relief. The participants also reported improvements in sleep and overall mood.
The bottom line
Spinal cord stimulators offer the opportunity for significant pain relief and improvements to quality of life for people living with diabetes-related nerve pain, without many of the unwanted side effects from medications. With First Relief, people now have an additional option that does not require surgery.
Learn more about neuropathy and spinal cord stimulation here: