Saluda Medical Achieves First-of-Its-Kind U.S. Cases Using CAP24 Paddle Lead

Saluda Medical has announced the first US surgical procedures using its newly FDA-approved Evoke CAP24 paddle lead, bringing physiologic closed-loop neuromodulation to spinal cord stimulation procedures involving paddle leads.

The initial procedures were performed in July at the University of Arkansas for Medical Sciences and Advanced Surgery Center of Lancaster in Pennsylvania. The cases marked the first use of Evoke closed-loop therapy with a surgical paddle lead in the United States.

CAP24 is designed to extend closed-loop neuromodulation to paddle lead procedures, which account for around 30 per cent of SCS implantations in the US. 

The lead is intended to detect neural signals from individual patients and support more precise adjustment of stimulation.

Unlike conventional approaches that rely mainly on programmed settings, closed-loop neuromodulation uses physiological feedback to help regulate therapy. 

The CAP24 paddle lead is specifically designed to work with the Evoke system and provide real-time information during treatment.

The technology is intended for patients receiving spinal cord stimulation for chronic neurological conditions. Saluda Medical said the Evoke system is supported by prospective, randomised clinical evidence reporting sustained outcomes through 36 months.

The introduction of CAP24 expands the range of surgical options available with Evoke therapy and provides a new pathway for clinicians who prefer paddle lead implantation for selected patients requiring spinal cord stimulation.