Saluda Medical Completes First U.S. Surgical Cases with New CAP24™ Paddle Lead

Saluda Medical, Inc. has announced the completion of the first surgical cases in the United States utilizing its newly FDA-approved Evoke® CAP24™ paddle lead. This development marks the initial delivery of Evoke® physiologic closed-loop therapy in surgical paddle lead procedures within the U.S., broadening the application of this advanced neuromodulation technology.

The landmark procedures were conducted by neurosurgeons at the University of Arkansas for Medical Sciences and the Advanced Surgery Center of Lancaster, Pennsylvania, earlier in July 2026. Paddle leads are a preferred choice for many neurosurgeons and orthopedic spine surgeons, representing approximately 30% of U.S. spinal cord stimulation (SCS) implants. The CAP24™ lead enables closed-loop neuromodulation for these cases, offering patients more consistent and objective therapy by automatically adjusting to neural signals.

"These first CAP24™ cases are an exciting advance for closed-loop therapy," stated Dr. Erika A. Petersen, Professor of Neurosurgery at the University of Arkansas for Medical Sciences. Dr. Steven M. Falowski, Director of Functional Neurosurgery at the Advanced Surgery Center of Lancaster, added that the ability to deliver closed-loop therapy in a paddle procedure "changes what we can offer surgical patients" and represents "an important evolution for SCS."

The CAP24™ lead is designed as the first SCS paddle lead engineered specifically for closed-loop neuromodulation. It senses individual neural signals to support precise, objective therapy adjustments. Saluda Medical's Evoke® system has demonstrated durable outcomes in prospective, randomized clinical trials, with long-term data published in peer-reviewed journals.