BLOOMINGTON, Minn., October 6, 2026
Saluda Medical, a commercial-stage medical device company focused on neuromodulation for chronic neurological conditions, has announced the full U.S. commercial release of its CAP24™ Surgical Paddle Lead following FDA approval earlier this year. The device is now broadly available to neurosurgery and orthopedic spine practices across the United States, expanding access to Saluda’s closed-loop, dose-controlled neuromodulation therapy for patients requiring a surgical paddle lead.
CAP24 Expands Access to Closed-Loop Neuromodulation
CAP24 is described by Saluda Medical as the first and only FDA-approved surgical paddle lead purpose-built for physiologic, dose-controlled closed-loop therapy. The lead enables the company’s Evoke® System to measure each patient’s unique neural response and automatically adapt stimulation with every pulse. Its low-profile and anatomically contoured design is intended to support stable placement while providing broad stimulation coverage. The full commercial release follows a successful limited market launch at selected U.S. medical centers. During that initial release, physicians provided positive feedback regarding the device’s performance and integration into clinical practice. Saluda is now making CAP24 available more broadly to neurosurgery and orthopedic spine practices nationwide. The expansion is significant because the surgical segment represents approximately 30% of U.S. spinal cord stimulation (SCS) implants. Until the availability of CAP24, Saluda’s Evoke Therapy had been delivered through percutaneous leads, limiting access for patients who require a paddle lead approach.
Evoke System Uses Real-Time Neural Feedback
The CAP24 Surgical Paddle Lead is designed to deliver Evoke Therapy, Saluda Medical’s closed-loop spinal cord stimulation technology. Unlike conventional open-loop approaches, the platform senses and measures neural responses to stimulation and uses this physiological information to adjust therapy in real time. This dose-control approach is intended to help maintain consistent stimulation as a patient’s neural response changes. According to Saluda, CAP24 provides real-time physiological feedback that allows stimulation to be adjusted as neural responses change, potentially supporting a more consistent and predictable treatment experience. The technology is supported by clinical evidence from the EVOKE study, which evaluated closed-loop versus open-loop spinal cord stimulation for chronic pain. Saluda reports that more than 90% of patients who responded at three months remained responders at 36 months, highlighting the durability of treatment response observed in the study.
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Saluda Broadens U.S. Patient Access
The nationwide commercial release represents an important step in Saluda Medical’s effort to make physiologic, dose-controlled closed-loop therapy available to a broader group of patients with chronic pain. The company’s Evoke System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. Saluda’s broader neuromodulation platform is designed to reduce the burden on patients and clinicians by using real-time neurophysiological feedback to optimize spinal cord stimulation therapy. Clinical evidence from the EVOKE program has included 12-month results published in The Lancet Neurology, 24-month results published in JAMA Neurology, and 36-month data published in Regional Anesthesia and Pain Medicine. With CAP24 now commercially available across the United States, Saluda Medical is expanding the reach of its closed-loop technology into the surgical paddle lead segment. The launch provides neurosurgeons and orthopedic spine specialists with access to a FDA-approved paddle lead designed specifically for closed-loop, physiologic dose control, marking another development in the evolution of personalized spinal cord stimulation for chronic pain management.
Source: Saluda Medical press release
