Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received CE Mark Certification in Europe for its HFX iQ™ spinal cord stimulation (SCS) system. The CE marking allows Nevro to market HFX iQ in all countries that recognize this certification.
HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief.*
“We are thrilled to receive the CE Mark Certification for HFX iQ as it marks an important milestone in our strategic path to drive market penetration through our data-backed, AI-powered SCS therapy,” said Kevin Thornal, Nevro’s CEO and president. “Patients in Europe suffering from chronic pain will now have access to personalized pain relief – and will be able to maintain that pain relief over time.”
“HFX iQ represents a transformative advancement in how we approach chronic pain management,” said Dr. Ganesan Baranidharan, anesthesia and pain management consultant at Leeds Teaching Hospital NHS Trust. “By leveraging AI technology and data-driven programming – developed using over 10 years of outcomes and real-world patient data – HFX iQ has the potential to not only help optimize healthcare resources through reduced in-person programming and unnecessary hospital visits, but it also sets new standards for earlier and effective pain management along with patient engagement in spinal cord stimulation.”
HFX iQ is digitally enabled and designed to optimize care by collecting patient data and guiding the patient through a personalized treatment pathway. It provides several key advantages over other SCS systems, including:
- Indication-specific HFX Algorithms™ for back and leg pain, non-surgical refractory back pain, painful diabetic neuropathy, chronic upper limb and neck pain.
- Customized therapy adjustment recommendations informed by patient inputs on the HFX App.
- The only 10 kHz Therapy™ that has CE-marked labeling for all major SCS indications and outcomes beyond pain relief.
“With HFX iQ, we are entering a new era of patient-centered pain management,” said Prof. Faycal El Majdoub, head of Stereotaxy and Functional Neurosurgery at Cologne-Merheim Medical Center. “The technology’s responsiveness to individual pain levels and real-time adaptation to patient needs means empowering patients in their pain relief journey. Patients experience an enhanced quality of life with few interruptions, allowing them to reclaim their lives with confidence and with less dependence on clinical interventions. HFX iQ is truly redefining what is possible for long-term pain relief.”
HFX iQ starts patients on the program most likely to provide pain relief, based on the HFX Algorithm™, which was built from more than 20 million data points and 80,000 implanted patients.1 HFX iQ combines clinical inputs, such as pain relief and pain score, along with Quality of Life (QoL) inputs, such as pain medication and activity level changes, to provide an individualized program setting for each patient.2 HFX iQ has the ability to program both low frequency and Nevro’s proprietary 10 kHz Therapy, which represents the widest range of frequencies of any SCS system on the market.
The Senza HFX iQ system is comprised of the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator and HFX App. With a new Bluetooth®-enabled IPG that is upgradeable and connects directly to the HFX App, each patient can input assessments into their smartphone and then receive programming adjustments in real-time.
In addition to receiving CE marking, HFX iQ received U.S. Food and Drug Administration (FDA) approval in 2022.
Nevro will offer the HFX iQ system in select European countries starting in the first quarter of 2025.