MINNEAPOLIS, Minn., July 1, 2026
Saluda Medical has achieved a major regulatory milestone with the U.S. Food and Drug Administration (FDA) approval of its CAP24™ Surgical Paddle Lead, expanding the capabilities of its Evoke® System with EVA™ Sensing Technology for the treatment of chronic intractable pain. The approval enables Saluda to commercialize the innovative surgical paddle lead across the United States and significantly broadens its presence in the growing spinal cord stimulation (SCS) market by allowing the company to address the neurosurgery and orthopedic surgery segments, which account for nearly 30% of all spinal cord stimulation implant procedures in the country. Designed exclusively for physiologic closed-loop neuromodulation, the CAP24™ Surgical Paddle Lead introduces a new generation of intelligent spinal cord stimulation capable of automatically adjusting therapy according to each patient’s real-time neural responses. The approval strengthens Saluda’s commercial growth strategy while advancing precision neuromodulation technology for patients suffering from chronic neurological pain conditions.
FDA Approval Expands Closed-Loop Neuromodulation Technology
The newly approved CAP24™ Surgical Paddle Lead represents the first and only spinal cord stimulation paddle lead specifically engineered for closed-loop neuromodulation using Evoked Compound Action Potential (ECAP) sensing technology. Unlike conventional paddle leads originally developed for open-loop stimulation systems, CAP24 was purpose-built to work seamlessly with the Evoke® System and EVA™ Sensing Technology, enabling continuous monitoring of neural responses and automatic adjustment of stimulation levels based on individual patient physiology. The device features an advanced 24-electrode, three-column design with a low-profile anatomical structure that supports stable placement, broad spinal cord coverage, and consistent ECAP signal acquisition.
By providing objective, physiology-driven therapy rather than fixed stimulation settings, the technology is designed to improve treatment precision, reduce clinician programming burden, and deliver more consistent long-term pain relief. The FDA approval also allows Saluda to expand its commercial reach beyond physicians performing percutaneous lead procedures to include neurosurgeons and orthopedic surgeons, significantly increasing the company’s addressable market.
Clinical Evidence Demonstrates Durable Pain Relief
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The CAP24™ Surgical Paddle Lead builds upon the proven clinical performance of the Evoke® System, which remains the only spinal cord stimulation platform supported by prospective, randomized, double-blind clinical trial evidence comparing closed-loop and open-loop neuromodulation. The landmark EVOKE clinical trial demonstrated superior pain relief with closed-loop therapy while maintaining durable outcomes through 36 months of follow-up.
Published in leading peer-reviewed medical journals, including The Lancet Neurology, JAMA Neurology, and Regional Anesthesia and Pain Medicine, the study established that continuous ECAP-guided stimulation enables objective therapy optimization while maintaining consistent neural activation over time. The approval of CAP24 extends these clinically validated benefits to patients receiving surgical paddle lead implantation, providing physicians with greater flexibility in selecting spinal cord stimulation procedures while preserving the advantages of real-time physiologic dose control.
Commercial Launch Supports Future Growth Strategy
Following FDA approval, Saluda Medical plans to begin a phased commercial launch across the United States during the second half of 2026, followed by broader market expansion as physician training programs and clinical inventory continue to grow. The company expects the addition of CAP24™ to strengthen productivity across its existing U.S. commercial organization by expanding procedural coverage within current hospital accounts while creating new opportunities among surgical specialists. As demand continues to increase for personalized, data-driven pain management solutions, Saluda believes its closed-loop neuromodulation platform is uniquely positioned to transform spinal cord stimulation therapy through objective, physiology-based treatment optimization.
By combining innovative device engineering with strong clinical evidence and regulatory approval, the company continues advancing its mission of improving long-term outcomes for patients living with chronic neuropathic pain while strengthening its leadership position in the rapidly evolving neuromodulation market.
Source: Saluda Medical press release
