Bloomington, Minnesota, USA | July 16, 2026

Saluda Medical announced that the U.S. Food and Drug Administration (FDA) has approved its CAP24™ surgical paddle lead, enabling the device to be marketed and sold in the United States. The approval expands the company’s spinal cord stimulation (SCS) portfolio by allowing the Evoke® System with EVA™ Sensing Technology to be used in surgical paddle lead procedures, significantly broadening Saluda’s addressable market among neurosurgeons and orthopedic surgeons.

Expanding Access to Closed-Loop Neuromodulation

The CAP24 is the first spinal cord stimulation paddle lead specifically engineered for physiologic closed-loop neuromodulation rather than traditional open-loop stimulation. Designed with a low-profile, anatomically contoured structure and a 24-electrode, three-column configuration, the device continuously senses evoked compound action potentials (ECAPs) and automatically adjusts stimulation based on each patient’s neural responses, enabling more personalized and consistent therapy delivery.

Commercial Launch Planned for Late 2026

Saluda plans a phased U.S. commercial launch beginning in the second half of 2026, followed by broader commercialization as surgeon training and inventory expansion progress. The company expects the new paddle lead to enhance productivity within its existing commercial organization by increasing engagement with neurosurgeons and orthopedic surgeons, who perform approximately 30% of spinal cord stimulation implant procedures in the United States.

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Clinical Evidence Supports Long-Term Outcomes

The CAP24 paddle lead integrates with the Evoke System, which is supported by prospective, randomized clinical evidence demonstrating durable pain relief through 36 months. The EVOKE clinical trial previously showed superior long-term outcomes for closed-loop spinal cord stimulation compared with conventional open-loop therapy, reinforcing the role of physiology-guided neuromodulation in the management of chronic neuropathic pain.

Source: Saluda Medical, press release