Saluda Medical received FDA approval for CAP24, a new surgical lead for its closed-loop Evoke spinal cord stimulation system. Unlike the thin, wire-like leads placed through a needle, a paddle lead is a flat, ribbon-shaped electrode array implanted surgically against the spinal cord, giving more stable, precise contact with the tissue. CAP24 senses the spinal cord's electrical response to stimulation and adjusts the therapy automatically, extending Saluda's closed-loop approach. Paddle leads are the format neurosurgeons and orthopedic surgeons prefer, a group that performs roughly 30% of US spinal cord stimulation procedures and one Saluda had not previously been able to reach. The company plans a phased US launch in the second half of 2026.

New 36-month data from Saluda's EVOKE program continues to show durable outcomes for its closed-loop spinal cord stimulation system. 90% of patients who responded after three months remained responders after three years. The Evoke system is the only platform that reads the spinal cord's own evoked response to stimulation, the ECAP, adjusting stimulation more than 100 times per second to keep therapy on target.