Nevro Corp announces it has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia Spinal Cord Stimulation (SCS) System to help treat chronic pain.
The Omnia system is reportedly the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy in addition to all other available SCS frequencies, according to the company. It is comprised of three new components.
The first is a new programmer that will make it easy for physicians to offer a wide array of waveforms across the full SCS frequency spectrum, either separately or paired together. The second element of the system is a redesigned patient remote that is smaller and more intuitive for patients to use and supports 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.
The Omnia system is designed to last over ten years no matter what stimulation profile is used, has conditional full body MRI approval and will be upgradeable to future waveforms and frequencies, according to a news release from the Redwood City, Calif-based company.
“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,” says 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, but it also gives physicians access to all other SCS frequencies, either independently or paired with HF10.”
[Source(s): Nevro Corp, PR Newswire]