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Saluda Medical Performs First U.S. Procedures With CAP24 Paddle Lead

Saluda Medical Performs First U.S. Procedures With CAP24 Paddle Lead

Surgeons in Arkansas and Pennsylvania have completed the first U.S. implantations of the CAP24 paddle lead, marking the debut of closed-loop neuromodulation for patients requiring this specific surgical hardware. The procedure, cleared by the FDA, allows Saluda Medical to expand its Evoke therapy into the paddle-based spinal cord stimulation market.

Dr. Erika A. Petersen of the University of Arkansas for Medical Sciences performed the initial procedure on July 10, followed by Dr. Steven M. Falowski at the Advanced Surgery Center of Lancaster on July 14. These operations represent a shift in spinal cord stimulation, as paddle leads account for roughly 30% of all implants in the United States but previously lacked access to Saluda’s physiologic, ECAP-based closed-loop technology.

Unlike traditional open-loop devices that deliver stimulation regardless of real-time patient response, the CAP24 system senses neural signals to calibrate therapy automatically. According to Mike Mathias, Saluda’s Chief Commercial Officer, the integration of this technology into paddle-lead procedures bridges a gap in the surgical channel. Clinical data supporting the Evoke platform, including randomized studies published in Regional Anesthesia and Pain Medicine, indicates that this physiologic approach provides durable pain relief for patients suffering from chronic neurological conditions.

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