European Market Now Gains Access to Omnia™ Spinal Cord Stimulation Platform Following CE Mark Certification

Nevro Corp. has secured CE mark approval for its Senza® Omnia™ Spinal Cord Stimulation system, marking a significant expansion of the company’s neuromodulation portfolio across Europe. The certification validates the next-generation platform’s readiness for addressing chronic pain management through advanced therapeutic options.

The Omnia Platform: A Comprehensive Redesign

The Senza Omnia system represents a complete architectural overhaul of Nevro’s spinal cord stimulation offerings. Rather than incremental improvements, Omnia introduces a fundamentally redesigned ecosystem comprising four key components working in concert.

The new programmer enables physicians to access a significantly broader therapeutic spectrum, supporting waveform combinations that weren’t previously possible. This flexibility extends to frequency modulation, with capabilities spanning from 2 Hz to 10,000 Hz—substantially exceeding the typical market ceiling of 1,200 Hz found in competing platforms.

Patient usability received equal emphasis in the design cycle. The redesigned remote provides enhanced intuitive controls while supporting expanded programming parameters. The slimmer charger incorporates an improved interface, reducing friction in daily patient management. The rechargeable implantable pulse generator maintains functionality for over a decade regardless of stimulation intensity, includes full-body MRI conditional approval, and offers future upgrade pathways for emerging waveform technologies.

Beyond HF10: Therapeutic Versatility as Core Strategy

Nevro’s proprietary HF10® therapy maintains its position as the cornerstone offering, with clinical evidence spanning 55,000+ patients worldwide. However, Omnia’s architecture enables physicians to deploy HF10 independently or paired with complementary waveform types—traditional paresthesia-based stimulation, subthreshold 1 kHz protocols, or burst modulation patterns.

This pairing capability addresses a previously identified clinical gap. Dr. Werner Braunsdorf, Chief Physician of Neurosurgery and Spine Surgery at Magdeburg Hospital, notes that while HF10 therapy has demonstrated strong efficacy in clinical settings, the ability to combine it with alternative waveforms provides unprecedented treatment flexibility. Similarly, Dr. Ganesan Baranidharan from Leeds Hospital NHS Trust anticipates deploying Omnia to expand therapeutic options for his patient population once deployment timelines permit.

Clinical Foundation and Market Positioning

Across six peer-reviewed studies, HF10 therapy has enabled ≥65% of patients to reduce or eliminate opioid dependency—a particularly significant outcome given the ongoing clinical need for non-pharmacologic chronic pain interventions. The Senza line now encompasses the original Senza platform, Senza II, and the newly approved Senza Omnia, all exclusively delivering Nevro’s HF10 technology.

The frequency range advancement—extending to 10,000 Hz from the previous competitive limitation of 1,200 Hz—provides clinicians with granular control over neuromodulation parameters. Combined with waveform pairing capabilities, Omnia delivers the highest configuration density currently available in the spinal cord stimulation market, allowing individualized therapeutic optimization for complex chronic pain presentations.

The European expansion follows the platform’s successful introduction in the U.S. market, establishing global availability for this advanced treatment modality.