Saluda Medical made its Cap24 surgical paddle lead commercially available across the U.S., giving neurosurgeons and orthopedic spine surgeons who implant paddle leads access to closed-loop spinal cord stimulation.
Saluda Medical announced the full commercial rollout following FDA approval of the device earlier this year. The company said the Cap24 is the first and only FDA-approved surgical paddle lead built for physiologic, dose-controlled closed-loop therapy, according to an Oct. 6 news release.
Paddle leads, which are placed surgically rather than percutaneously, make up about 30% of U.S. spinal cord stimulation implants, according to the company. Closed-loop therapy has until now been tied to percutaneous leads.
Paired with the company’s Evoke System, Saluda said the Cap24 measures each patient’s neural response to stimulation and adjusts the dose with every pulse, which is designed to keep therapy consistent as patients move and the spinal cord shifts position.
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