Nevro has earned CE mark certification in Europe for its HFX iQ spinal cord stimulation (SCS) system to treat chronic pain.

According to the company, HFX iQ is the first, only SCS system with artificial intelligence (AI) tech that merges high-frequency (10kHz) therapy built on landmark evidence that uses ongoing could data to deliver personalized pain relief.

The HFX iQ SCS received U.S. Food and Drug Administration (FDA) approval in 2022. Following limited market release, it was fully launched in the U.S. in March 2023.

Nevro said the HFX iQ system will debut in select European countries beginning in the first quarter of 2025.

“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.”

More about the Senza HFX iQ SCS

The system is comprised of the HFX iQ implantable pulse generator (IPG), HFX trial simulator, and HFX app. The Bluetooth-enabled IPG is upgradeable and connects to the HFX app so patients can input assessments into their smartphone and receive programming adjustments in real-time.

It features indication-specific HFX algorithms for back and leg pain, non-surgical refractory back pain, painful diabetic neuropathy, chronic upper limb and neck pain.

Patients are started on the program most likely to offer pain relief based on the HFX algorithm. This algorithm was built from over 20 million data points and 80,000 implanted patients, according to Nevro. 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.

“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.”