Spinal cord stimulators have grown in popularity over the past several years as patients see benefits in the less-invasive procedure.
Stimulators help patients to treat chronic pain without invasive spine or back surgery, and they can treat a wide range of pain types, as well as pain from different types of conditions or sources.
They can also replace other forms of pain management, such as opioids, which can be addictive.
Here is a timeline of how spinal cord stimulators have advanced in the U.S. since 2023:
2023
January: A long-term study of Saluda Medical’s Evoke spinal cord stimulator found most patients had significant pain reduction and no explants.
February: Therapy development company Aneuvo launched a clinical trial for its ExaStim TSS system, a wirelessly controlled, noninvasive spinal cord stimulator. The ExaStim neurostimulator received FDA breakthrough device designation status.
May: Spinal cord stimulator use was expanded when National Surgical Center Stockton (Calif.) began offering HFX, high-frequency spinal cord stimulation procedures for the treatment of diabetic neuropathy.
Abbott’s spinal cord stimulation devices earned FDA approval to address chronic back pain for patients who aren’t eligible for spine surgery.
August: Medtronic received CE Mark approval for its latest spinal cord stimulator.
Mainstay Medical completed enrollment for its randomized clinical trial for its ReActiv8 restorative neurostimulation device intended to help patients with chronic lower back pain.
September: Onward’s ARC-IM spinal stimulator was implanted in the first human patient.
December: Medical societies representing 95,000 members expressed their “profound objection” to Cigna’s characterization of closed-loop spinal cord stimulation therapy as “experimental, investigational, and/or unproven.” The groups said they believed closed-loop SCS devices should be covered under similar provisions as other SCS devices.
2024
January: John Mansell, MD, a pain management physician, became the first in Wyoming, Colorado, Montana, North Dakota or South Dakota to implant a closed-loop spinal cord stimulator.
February: The FDA approved Boston Scientific’s WaveWriter SCS Systems for treating chronic low back and leg pain in people without prior back surgery.
April: Medtronic earned FDA approval for its Inceptiv closed-loop spinal cord stimulator. The rechargeable spinal cord stimulator is designed for patients with chronic pain, and it is Medtronic’s first closed-loop device.
May: Some spinal cord injury patients saw significant improvement in hand and arm function after using Onward Medical’s Arc-EX spinal cord stimulator. Results of a clinical trial for the Arc-EX therapy reached all primary safety and effectiveness endpoints, and the device showed “significant improvements in upper limb strength, function, and sensation” in patients with chronic tetraplegia due to cervical SCI.
September: Nevro earned FDA approval and began a limited market release of its HFX iQ spinal cord stimulator with HFX AdaptivAI.
October: Allied Market Research forecasts the spinal cord stimulator market is expected to grow to $4.8 billion by 2032.
November: Nevro’s HFX iQ spinal cord stimulator earned the European Union’s CE mark.
December: Onward’s Arc-Ex spinal cord stimulator earned the FDA’s de novo classification and U.S. market authorization.
December: Columbia (S.C.) VA Health Care System performed its first spinal cord stimulation implantation.
2025
January: Onward Medical’s Arc-EX spinal cord stimulator saw its first U.S. sales.
Saluda Medical earned FDA approval for its biomarker-based automated patient programming platform used in spinal cord stimulation. The platform, Eva, is compatible with all commercially implanted Evoke spinal cord stimulator systems.
February: Globus Medical announced plans to acquire Nevro Corp., a spinal cord stimulator company, for $250 million.