Nevro, a Silicon Valley-based company, announced that it has received CE mark approval for its Senza Omnia Spinal Cord Stimulation (SCS) system for management of chronic pain. The device was FDA approved for chronic pain in November 2019.
Nevro touts its device as the first and only that is designed to deliver all frequencies from 2 to 10,000 Hz, compared to the 1-1,200 Hz range provided by traditional SCS. The Senza Omnia can also simultaneously deliver both low and high frequencies to different parts of the spinal cord.
The system consists of an implantable pulse generator, the Omnia programmer, and a remote for patient control. The pulse generator battery lasts ten years regardless of stimulation profile used by the patient. The device also has conditional full body MRI approval.
“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 D. Keith Grossman, CEO of Nevro, in a statement. “This next-generation SCS system has been developed in close consultation with customers and is designed to provide a comprehensive solution to manage chronic pain. Omnia’s versatility means that patients now have access to a full range of SCS solutions and physicians can have the peace of mind that when they implant the system, they will have the capabilities needed to achieve the best possible outcomes for their patients.”