Saluda Medical Inc - SLD receives FDA approval for CAP24 surgical paddle lead
Saluda Medical Inc (SLD) has received approval from the U.S. Food and Drug Administration (FDA) for its CAP24 surgical paddle lead, a component of its Evoke® Spinal Cord Stimulation (SCS) System. The CAP24 surgical paddle lead is designed to work in conjunction with the Evoke® System, which was previously approved by the FDA for chronic intractable pain treatment, including conditions such as failed back surgery syndrome, intractable low back pain, and leg pain.
The Evoke® System is the first and only SCS system capable of instantaneously reading, recording, and responding to evoked compound action potentials (ECAPs)—the nerves’ response to stimulation—to provide precise, continually optimized therapy. The system adjusts therapy more than 100 times per second, maintaining optimal pain inhibition and capturing millions of data points per day for clinical insights.
The approval of the CAP24 surgical paddle lead expands Saluda Medical’s product portfolio and supports the broader commercialization of the Evoke® System. The company plans to implement controlled, limited release of Evoke® System in the second half of 2022 among select trial sites before initiating a full commercial release in 2023.
The Evoke® System has demonstrated superior pain relief and clinically meaningful improvements in patient-reported outcomes, including physical and emotional functioning, sleep quality, and health-related quality of life, based on the results of the EVOKE Study, a double-blind randomized controlled trial. The system’s closed-loop technology has been shown to maintain spinal cord activation within the therapeutic window 95.2% of the time, compared to 47.9% with open-loop SCS.
The approval of the CAP24 surgical paddle lead reflects Saluda Medical’s ongoing commitment to advancing neuromodulation technologies and addressing unmet needs in the treatment of chronic pain. The company’s research and development efforts have been supported by strong partnerships with the clinical community and a focus on patient-centric innovation.
