Nevro, a firm based in Silicon Valley, won FDA approval for its Senza Omnia spinal cord neurostimulation system for chronic pain management. The device can deliver traditional spinal cord stimulation at frequencies below 1.5 kHz, along with Nevro’s proprietary HF10 stimulation that goes up to 10 kHz. Both low and high frequency therapies can even be provided at the same time.
The Senza Omnia can operate at frequencies between 2 and 10,000 Hertz, a range unheard of in a spinal cord stimulator. It is a rechargeable device and is guaranteed to maintain functionality for at least ten years, regardless of the stimulation regimen that ends up working best for the patient.
It is also MRI-conditional, meaning that patients will be able to safely receive MRI scans, as long as certain precautions are taken.
The Senza Omnia appears to be an improved version of the company’s original Senza that introduced high frequency spinal cord stimulation for pain control. The Omnia features a new physician programmer that should be easier to operate, a new patient remote control that has been slimmed down and made more intuitive, as well as the implant being more amenable to future upgrades with newly developed waveforms or frequencies.
Here’s the Chairman and CEO of Nevro introducing the Omnia:
Flashbacks: Nevro Senza High Frequency Spinal Cord Stimulator Gets Green Light by FDA; Nevro Senza Spinal Cord Stimulator Cleared in EU, Australia for 3T MRI Use; Nevro Senza High Frequency Neurostimulator Going on Trial in U.S.
Product page: Senza Omnia