A global medical device company – Nevro Corp, has been long providing an evidence-based and innovative solution for the cure of chronic pain. And today it had announced the approval of the Senza Omnia Spinal Cord Stimulation (SCS) System by the U.S. Food and Drug Administration (FDA).
The Omnia SCS system, launch in the U.S., is the first and only SCS designed to provide Nevro’s proprietary HF10 therapy along with all other available SCS frequencies.
The Omnia Spinal Cord Stimulation System to relieve chronic pain
This system consists of three new components. The first one is a new programmer that makes it easy for physicians to present a wider range of waveforms throughout the full SCS frequency spectrum, either independently or paired together.
Whereas, the second component of the Omnia system is a redesigned patient remote. This new remote enhances the experience of patients and is smaller and more intuitive for users.
Moreover, it also supports greater programming capacity. That grants the flexibility to expand on the HF10 algorithm by giving physicians the capability to provide additional waveforms. Lastly, the Omnis SCS system comes with an upgradeable and updated implantable pulse generator.
Contrary to non-rechargeable systems, it is designed to last for more than ten years. This system has conditional full-body MRI approval and will be upgradeable to future frequencies and waveforms.
Keith Grossman is CEO and Chairman of Nevro. He said that they are excited to launch Nevro’s next-generation SCS system as they believe it will permit physicians to help more patients with chronic pain.
Grossman stated that the Omnia system was developed on the basis of feedback from the pain community. And has ended with a product that Nevro is exclusively able to provide. HF10 is the most studied therapy presented in the market that physicians have offered to more than 53,000 patients.
Approval by FDA
The Omnia system not only offers HF10 but also provides physicians access to all other SCS frequencies, either separately or paired with HF10. The pairing of waveform across different ranges of frequency enables the dual mechanism of action that no other system can provide.
The goal of Omnia is to provide peace of mind to physicians that when they insert the system, they will have the versatility required to achieve the best possible results for their patients.
Other SCS systems available in the market have a frequency below 1500 Hz. But Omnia provides the widest array of frequencies of any SCS system, that is between 2 and 10,000 Hertz.
Kasra Amirdelfan is Director and M.D. of Medical Research at IPM Medical Group in Walnut Creek, California. He said that approval of Omnia by the FDA to treat chronic reflects what he has seen firsthand in his practice.
Many people suffering from chronic pain require a versatile solution to cure the dynamic, and sometimes progressive nature of pain. Omnia can provide patients the proven advantages of HF10 therapy, with still having access to all other SCS frequencies.
Amirdelfan said that the patient’s response in his practice during the limited evaluation period has been positive. And he is looking forward to providing the Omnia system more broadly in his practice.