The Food and Drug Administration (FDA) has approved the Senza Omnia Spinal Cord Stimulation (SCS) System (Nevro) for the treatment of chronic intractable pain of the trunk and/or limbs.

The Omnia SCS system is the first to deliver Nevro’s proprietary HF10 therapy (continuous stimulation at 10,000 Hz) as well as all other available SCS frequences (between 2 and 10,000 Hz). It is an updated iteration of the Company’s Senza System, which was first approved in 2015.

The Omnia includes a newly designed programmer for physicians, a redesigned patient remote, and an updated and upgradable implantable pulse generator. The system is designed to last for over 10 years and will be upgradable to future waveforms and frequencies. The device can be programmed to provide waveforms independently or paired with HF10, providing dual mechanisms of action. 

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“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,” said Keith Grossman, Chairman and CEO of Nevro. “With Omnia, our goal is to provide physicians the peace of mind that when they implant the system, they will have the versatility needed to achieve the best possible outcomes for their patients.”

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