Saluda Medical (ASX: SLD) has announced the full U.S. commercial release of the FDA-approved CAP24 Surgical Paddle Lead making it available to neurosurgery and orthopedic spine practices in selected centers across the U.S.
CAP24 is the first and only FDA-approved surgical paddle lead purpose-built for physiologic, dose-controlled closed-loop therapy. It enables the company’s Evoke System to measure each patient’s unique neural response and adapt stimulation with every pulse. Its low-profile, anatomically contoured design supports stable placement and broad coverage.
In a statement, Erika Petersen, MD, professor of neurosurgery at the University of Arkansas for Medical Sciences, commented, “CAP24 is the first surgical paddle lead designed to support dose-controlled therapy. By providing real-time physiologic feedback, it allows stimulation to be adjusted as neural responses change, helping maintain consistent therapy delivery and a more predictable treatment experience.”
Mike Mathias, CEO of Saluda, remarked, “EvokeTM Therapy has changed what patients and treating physicians can expect from SCS. Until recently, it has only been available through percutaneous leads. The full commercial release of CAP24 expands access to our one-of-a-kind therapy for patients who require a paddle lead. This marks an important step towards making physiologic, dose-controlled closed-loop therapy available to all appropriate patients.”
