The CAP24 lead represents a shift in spinal cord stimulation hardware, as it is the first device specifically engineered to integrate with Saluda’s Evoke System and its proprietary EVA Sensing Technology. While traditional paddle leads were originally developed for open-loop systems, the CAP24 utilizes a 24-electrode, three-column configuration to sense evoked compound action potentials (ECAPs). This allows the device to adjust stimulation automatically based on a patient’s unique neural signals.
In section Releases
Saluda Medical Gains FDA Clearance for CAP24 Neuromodulation Paddle Lead
The U.S. Food and Drug Administration has cleared Saluda Medical’s CAP24 surgical paddle lead, a move that grants the company entry into the orthopedic and neurosurgical markets. This approval allows the firm to extend its closed-loop neuromodulation technology to surgeons who favor paddle-based spinal cord stimulation procedures over percutaneous methods.
By capturing this segment of the market, Saluda aims to reach the neurosurgeons and orthopedic specialists who currently perform roughly 30% of all spinal cord stimulation implants in the United States. CEO Barry Regan noted that the development allows for a broader application of closed-loop therapy, which has demonstrated durable pain relief results in clinical trials spanning up to 36 months. The company intends to initiate a phased rollout of the new lead in the second half of 2026, scaling its field inventory and surgeon training programs as it seeks to integrate the technology into existing commercial accounts.
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