Spinal cord stimulation system for chronic pain gets FDA approvalJanuary 6, 2020
The US FDA has granted approval for Senza Omnia Spinal Cord Stimulation (SCS) System.
The system is meant for the treatment of chronic intractable pain of the trunk and limbs.
Omnia delivers the widest range of frequencies of any SCS system, between 2 and 10,000 hertz.
In addition to HF10, the system offers the most waveforms in a single product and can be programmed to provide waveforms independently or paired with HF10.
The pairing of waveforms across frequency ranges enables dual mechanisms of action that no other system can offer, Nevro said.
The system is comprised of three new components. The first is a new programmer that will make it easy for physicians to offer a wider 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 enhances their experience.
The new remote supports greater programming capacity, allowing for the flexibility to expand on the HF10 algorithm by giving physicians the ability to provide additional waveforms.
The system comes with an updated and upgradeable implantable pulse generator.