Nevro receives US FDA approval for Senza Omnia spinal cord stimulation system


Nevro Omnia


Nevro has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia spinal cord stimulation system to treat chronic pain. The Omnia system is designed to deliver Nevro’s proprietary HF10 therapy in addition to other available spinal cord stimulation frequencies.

The Omnia system is comprised of three new components. The first is a programmer designed to make it easy for physicians to offer a wider array of waveforms across the full spinal cord stimulation frequency spectrum, either separately or paired together.

The second element of the Omnia system is a redesigned patient remote that is smaller and more intuitive for patients to use. The new remote is designed to support greater programming capacity, allowing for the flexibility to expand on the HF10 algorithm by giving physicians the ability to provide additional waveforms. Lastly, the system comes with an updated and upgradeable implantable pulse generator.

“We are excited to launch Nevro’s next-generation spinal cord stimulation system as we believe it will allow physicians to help even more patients,” said Keith Grossman, chairman and CEO of Nevro. “The Omnia system was developed based on feedback from the pain community and has resulted in a product that Nevro is uniquely able to provide. Omnia not only offers HF10, the most studied therapy available in the market that physicians have provided to over 53,000 patients, but it also gives physicians access to all other SCS frequencies, either independently or paired with HF10.”


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