Approximately one-third of all diabetes patients develop diabetic peripheral neuropathy, in which nerves damaged by high blood sugar levels lead to discomfort ranging from numbness to excruciating pain. It’s typically treated with medication, though those drugs have been proven to stop short of fully relieving pain.
Medtronic, however, claims to have found a more comprehensive treatment for the condition, and, with the FDA’s newly bestowed approval, it’ll soon be available to the estimated 800,000 U.S. patients experiencing moderate to severe pain from diabetic neuropathy for whom standard treatments haven’t been successful.
The new approach revolves around Medtronic’s neurostimulation technology, in which small devices are implanted in the epidural space between the vertebral canal and the spinal cord. Once in place, the devices emit electrical pulses to intercept and block pain signals in the nervous system before they can reach the brain.
The Intellis and Vanta spinal cord stimulators have already been cleared to lessen chronic pain caused by a variety of conditions, and those indications now include the treatment of painful diabetic neuropathy.
The FDA approval was awarded based on studies that compared the therapeutic effects of the neurostimulation implants to drug-based treatments alone.
On average, 70% of diabetic neuropathy patients who received the implant experienced pain relief, compared to just 6% of the other group. Additionally, those implanted with the device said that pain relief amounted to a reduction of about 53% in their average pain levels, while the patients treated only with standard drug regimens reported no overall reductions in their pain.
In the long term, Medtronic’s spinal cord stimulators proved not only to have a high use rate—with 80% of those in one of the studies’ test group continuing to use the device after five years—but also to result in an improved quality of life for patients with painful diabetic neuropathy.
With the regulator’s approval, those patients in the U.S. can now be treated with either the Intellis or the Vanta neurostimulators. The former is rechargeable and the latter recharge-free, and both are designed to be personalized to each patient’s pain relief needs.
The expanded indication comes shortly after Vanta received its initial approval to treat chronic pain last June and several years after Intellis’ own 2017 approval.
Medtronic claims that the non-rechargeable Vanta device massively improves on previous spinal cord stimulators’ offerings. The system can last up to 11 years before requiring a surgical replacement—10% longer than previous models—and is about 20% smaller than its predecessors.
Plus, in study results presented this month, the company found that patients who used the Vanta device equipped with Medtronic’s lower-power Differential Target Multiplexed therapy experienced an average 4.2-point drop in back pain levels and a 5-point drop in leg pain after just three months of treatment, after starting at levels between 7 and 8 on a 10-point pain scale.