#Saluda Medical #SCS therapy #CAP24 lead

Saluda Medical's CAP24 Surgical Paddle Lead Approved by FDA

Saluda Medical, Inc. has reached a significant milestone with the recent approval of its CAP24 paddle lead by the U.S. Food and Drug Administration (FDA). This groundbreaking device expands the medical company's portfolio in the fast-evolving field of spinal cord stimulation (SCS) therapy, especially for patients suffering from chronic neurological conditions. With this approval, Saluda enters a new phase of growth, opening avenues to both neurosurgeons and orthopedic surgeons who rely on paddle leads for SCS procedures.

What is the CAP24 Paddle Lead?

The CAP24 paddle lead is not an ordinary medical device. It is the first specialized SCS paddle lead engineered specifically for closed-loop neuromodulation therapies. This innovative technology allows for real-time assessment of a patient's unique neural signals, fine-tuning the therapy accordingly. Unlike traditional paddle leads, which were designed for open-loop stimulation, the CAP24 offers a responsive, tailored approach to pain management.

Key features of the CAP24 paddle lead include:

• - 24-Electrode Configuration: It employs a unique three-column design that is capable of sensing evoked compound action potentials (ECAPs).
• - Integration with Evoke System: The paddle lead is compatible with Saluda's Evoke System, which leverages advanced EVA Sensing Technology to adjust stimulation based on real-time physiological feedback.
• - Anatomical Design: The low-profile design ensures stable and precise placement, enhancing both patient comfort and treatment efficacy.

Market Impact and Launch Plans

Saluda plans to initiate a phased rollout of the CAP24 paddle lead in the U.S. starting in the second half of 2026. This strategic launch will include comprehensive surgeon training and scaling up of field inventory, ensuring that clinicians are well-prepared to utilize this innovative technology. By targeting neurosurgeons and orthopedic surgeons—who constitute approximately 30% of all SCS procedures—the company aims to significantly broaden its market reach and reinforce its competitive standing in the industry.