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Medical Devices / Submissions and Approvals

Saluda Handed CE Mark for Spinal Cord Stimulator

Sept. 17, 2019
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Saluda Medical has received the CE Mark for its Evoke closed-loop spinal cord stimulation (SCS) device, a product that measures the spinal cord’s response to stimulation.

“For the first time we can directly measure each individual patient's neurophysiological response to SCS and use this objective data to guide how we program the system to best treat their individual pain complaint,” said Harold Nijhuis, anesthesiologist and pain management consultant at St. Antonius Hospital, Nieuwegein, The Netherlands.

The company hails the device as the first closed-loop system that can adjust on every pulse to optimize stimulation for individual patients.

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