Saluda Medical Wins FDA Approval for CAP24 Paddle Lead in U.S.
FDA clears Saluda’s CAP24 paddle lead, opening a new surgical channel in the U.S.
The U.S. Food and Drug Administration (FDA) has approved Saluda Medical’s (ASX: SLD) CAP24 surgical paddle lead for marketing and sale in the U.S., dated 30 June 2026. The clearance opens a direct channel to neurosurgeons and orthopedic surgeons, the customer segment that generally prefers surgically implanted paddle leads and accounts for approximately 30% of all SCS implants in the U.S.
This represents a meaningful expansion of Saluda’s addressable market beyond its current percutaneous lead-focused customer base. CAP24 enables use of the Evoke System with EVA Sensing Technology in surgical paddle lead procedures, extending the Company’s physiologic closed-loop, ECAP-based therapy to a new procedural setting.
The device is described as the “first and only SCS paddle lead purpose-built to deliver Evoke’s physiologic closed-loop neuromodulation,” distinguishing it from traditional paddle leads originally designed for open-loop stimulation.
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What the approval unlocks for Saluda’s addressable market
Paddle leads are an alternative to percutaneous leads. They are surgically implanted and generally preferred by neurosurgeons and orthopedic surgeons when performing a spinal cord stimulation (SCS) procedure. With the FDA approval, Saluda can now engage a customer segment it could not previously serve through its percutaneous-focused offering.
The strategic benefit is twofold. The addition of a paddle lead is expected to enhance productivity within Saluda’s existing U.S. commercial organisation by enabling engagement with these surgeons, while expanding procedural coverage within existing accounts.
| Detail | What It Is | Investor Significance |
|---|---|---|
| New addressable segment | Surgeon-preferred paddle procedures, ~30% of U.S. SCS implants | Material expansion beyond the current percutaneous-focused base |
| Surgeon types targeted | Neurosurgeons and orthopedic surgeons | Access to a customer group previously outside Saluda’s reach |
| Channel benefit | Expanded procedural coverage within existing accounts | Enhanced productivity of the existing U.S. commercial organisation |
Barry Regan, Chief Executive Officer, Saluda Medical
“The FDA approval of the CAP24 surgical paddle lead marks an important milestone for Saluda Medical. CAP24 was engineered from the ground up to bring closed-loop therapy to surgical paddle lead procedures, enabling surgeons and clinicians to more fully leverage the benefits of the Evoke System and EVA Sensing Technology in these cases.”
Understanding closed-loop neuromodulation and the CAP24 design
Spinal cord stimulation is a therapy used to manage chronic intractable pain of the trunk and limbs. This includes pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Evoke System delivers SCS therapy intended to treat chronic neuropathic pain.
Closed-loop neuromodulation works differently to traditional open-loop stimulation. The system senses and measures evoked compound action potentials (ECAPs), the neural signals produced when stimulation is delivered, and automatically adjusts therapy to each patient’s physiology. Traditional open-loop systems deliver a fixed level of stimulation without that real-time feedback.
For investors, the distinction matters because differentiated, evidence-backed technology supports premium positioning and durable clinical adoption.
CAP24’s technical features include:
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A unique 24-electrode, three-column configuration
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A low-profile, anatomically contoured design for stable, precise placement
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Broad lateral and longitudinal coverage supporting consistent ECAP sensing
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Engineering from the ground up for closed-loop therapy, rather than an adapted open-loop design
Erika Petersen, MD, Professor of Neurosurgery, University of Arkansas for Medical Sciences (UAMS)
“The CAP24 paddle was clearly designed with closed-loop therapy in mind. Its anatomical design, stability, and integration with the Evoke System and EVA Sensing Technology allow surgeons to deliver objective, physiology-based neuromodulation in a surgical paddle lead, which is an important advancement for spinal cord stimulation.”
Clinical evidence behind the Evoke System
The Evoke System is supported by prospective, randomised clinical evidence demonstrating durable outcomes through 36 months. The peer-reviewed publication record of the EVOKE randomised controlled trial provides the clinical foundation that may support surgeon confidence as Saluda enters the new channel.
The three publication milestones are:
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12-month results published in The Lancet Neurology
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24-month results published in JAMA Neurology
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36-month sustained pain relief data published in Regional Anesthesia and Pain Medicine
This body of peer-reviewed evidence, extending through three years of follow-up, underpins the clinical case for adoption among surgeons evaluating the platform.
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Phased U.S. launch and what comes next
Saluda plans a phased U.S. launch beginning in the second half of calendar 2026, with broader commercial rollout commencing later in calendar 2026 as surgeon training and field inventory scale.
Investors should note the measured commercial framing. The Company expects a gradual contribution to revenue as the surgical channel develops. No revenue figures were disclosed, and management has not indicated an immediate or large uplift.
The launch leverages Saluda’s existing U.S. commercial organisation rather than requiring a new build-out, with the paddle lead expected to enhance the productivity of teams already engaging customers in the field.
Taken together, an expanded SCS portfolio combined with access to surgeon-preferred procedures positions Saluda to pursue a broader U.S. growth profile as the surgical channel matures.
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