For 20 years, competition in spinal cord stimulation centered on waveforms. Increasingly, the differentiator is whether the system can sense and respond to the spinal cord itself.
That shift became more consequential this summer. Saluda Medical received FDA approval for its CAP24 surgical paddle lead, extending its physiologic closed-loop therapy into a segment that had previously been inaccessible to the company. The first U.S. procedures followed on July 10 and July 14 in Arkansas and Pennsylvania.
The significance is bigger than another lead entering the market. Saluda can now bring its closed-loop technology into a surgical channel representing roughly 30% of U.S. SCS implants.
The spinal cord stimulation market reached approximately $3.34B in 2025 and is projected to approach $6.5B by 2030, representing a CAGR of roughly 14%.
Most of that market belongs to four companies: Medtronic, Abbott, Boston Scientific, and Nevro, which Globus Medical acquired for $250M in early 2025. Together, they account for approximately 75% of global SCS sales.
Saluda has raised about $664M across eight funding rounds and added another $150M through its ASX listing in late 2025. At the center of its strategy is Evoke, a closed-loop SCS system that measures evoked compound action potentials, or ECAPs, and adjusts stimulation in real time to hold the dose inside the therapeutic window.
The clinical evidence is central to the company’s position. In the double-blind EVOKE randomized controlled trial, closed-loop stimulation maintained neural activation within the therapeutic window 95.2% of the time, compared with 47.9% for open-loop stimulation. Superiority was demonstrated at 12 months in The Lancet Neurology and at two years in JAMA Neurology, with follow-up out to 36 months.
Until CAP24, Evoke was limited to percutaneous leads. That meant Saluda could address roughly 70% of U.S. SCS implants while having no product for the approximately 30% performed using surgically placed paddle leads.
CAP24 changes the addressable market, but it does not guarantee market share. It simply gives Saluda something strategically important: the ability to compete across both major lead categories.
That matters in an oligopoly where product breadth, physician familiarity, hospital relationships, and switching costs reinforce incumbent positions.
Saluda did not invent a better waveform; it changed what the device optimizes for.
With conventional open-loop stimulation, a fixed output can become less consistent as movement and posture change the distance between the lead and spinal cord. Closed-loop technology instead measures the neural response and adjusts stimulation in real time.
Saluda no longer owns that territory alone. Medtronic received FDA approval for Inceptiv in April 2024, bringing its own ECAP-sensing closed-loop system to market. Inceptiv is also the only closed-loop SCS cleared for full-body 3T MRI.
Medtronic’s entry both validates the closed-loop premise and raises the competitive bar. Saluda cannot match Medtronic’s scale or distribution, while Medtronic cannot point to the same long-term blinded randomized evidence supporting its closed-loop system.
The question is whether Saluda’s evidence base, expanded product portfolio, and access to capital are enough to take share in a category dominated by much larger competitors.
Boston Scientific and Abbott are the obvious companies to watch. Neither currently offers a physiologic closed-loop, ECAP-sensing SCS system comparable to Evoke or Inceptiv. If sensing continues to become a defining competitive feature, that capability gap becomes increasingly difficult to ignore.
CAP24 adoption will provide another important signal. Paddle leads went from an inaccessible segment for Saluda to an addressable market representing approximately 30% of U.S. implants. How quickly those procedures contribute to implant volume and revenue will show whether completing the product portfolio materially changes the company’s trajectory.
The larger story is what happens to SCS itself. If closed-loop systems can strengthen confidence in the consistency and efficacy of stimulation, the opportunity is not simply to redistribute a $3.34B market among the incumbents and Saluda Medical. It is to help expand the market they are competing to capture.
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