Nevro (NYSE:NVRO) announced today that it has received CE mark approval for the Senza Omnia spinal cord stimulation (SCS) system.
The system won FDA approval in November 2019. It is is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy, as well as other available SCS frequencies, according to the company.
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 company.
“Following a successful launch in the United States late last year, we are excited to now have approval for the Senza Omnia SCS system in Europe,” said Nevro president & CEO D. Keith Grossman in a news release. “As conditions in the marketplace allow, we will be introducing Omnia to physicians throughout Europe.”