US-based medical device company Nevro has received CE mark approval to market its HFX iQ spinal cord stimulation (SCS) system in European countries.
The AI-powered SCS system combines high-frequency (10 kHz) therapy, evidence that uses ongoing cloud data insights to deliver personalised pain relief.
HFX iQ is digitally enabled and designed to optimise care by collecting patient data and guiding the patient through a personalised treatment pathway.
Nevro said the HFX iQ system provides several key advantages over other SCS systems.
It enables indication-specific HFX Algorithms for back and leg pain, non-surgical refractory back pain, painful diabetic neuropathy, chronic upper limb, and neck pain.
The system provides customised therapy adjustment recommendations informed by patient inputs on the HFX App.
Also, it is the only 10 kHz Therapy with CE-marked labelling for all major SCS indications and outcomes beyond pain relief, said the company.
Nevro CEO and president Kevin Thornal said: “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.
“Patients in Europe suffering from chronic pain will now have access to personalised pain relief – and will be able to maintain that pain relief over time.”
HFX iQ provides patients with pain relief, building on its HFX Algorithm, which was built from more than 20 million data points and 80,000 implanted patients.
It combines certain clinical inputs and Quality of Life (QoL) inputs to provide a personalised programme setting for each patient.
The clinical inputs include pain relief and pain score, and QoL inputs include pain medication and activity level changes.
Also, HFX iQ can programme both low frequency and Nevro’s unique 10kHz Therapy, the widest range of frequencies of any SCS system on the market.
Nevro’s Senza HFX iQ system comprises the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator and HFX App.
It features a new Bluetooth-enabled IPG that is updated and connected directly to the HFX App, allowing each patient can input assessments and receive adjustments in real-time.
Cologne-Merheim Medical Centre stereotaxy and functional neurosurgery head Faycal El Majdoub said: “With HFX iQ, we are entering a new era of patient-centred pain management.
“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.”
