Nevro (NYSE:NVRO) said today that it won FDA approval for and launched its Senza Omnia spinal cord stimulation system.
The Senza Omnia is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy, as well as other available SCS frequencies, Nevro said in a news release.
Redwood City, Calif.–based Nevro’s Omnia system is designed to last over 10 years and has conditional full-body MRI approval with upgrades to be made available for future waveforms and frequencies.
The system consists of a new programmer designed to enable physicians to offer a wider range of waveforms, a redesigned patient remote with increased intuitiveness and an updated and upgradeable implantable pulse generator.
Omnia delivers between two and 10,000 hertz, while most SCS systems are limited to a frequency below 1,500 hertz, according to the release.
Nevro expects Omnia to win European approval in the first half of 2020 and Australian approval in the latter part of next year.
“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,” Nevro chairman & CEO Keith Grossman said in the release. “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. 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.”
“The FDA approval of Omnia to treat chronic pain reflects what I’ve seen firsthand in my practice: many people suffering from chronic pain need a versatile solution to treat the dynamic, and sometimes progressive, nature of pain,” added IPM Medical Group (California) director of medical research Dr. Kasra Amirdelfan. “With Omnia, we can now offer patients the proven advantages of HF10 therapy while still having access to all other SCS frequencies. The patient response in my practice during the recent limited evaluation period has been positive and I look forward to providing the Omnia system more broadly in my practice.”
