Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

Nevro’s spinal cord stimulation (SCS) device system is the first and only AI-based SCS system that “learns from patients,” says Nevro. (Photo: Nevro Corp)

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain.

According to Nevro, the Senza HFX iQ is the first and only artificial intelligence (AI)-based SCS system that “learns from patients.”

It delivers personalized care through its digital capabilities and collection of patient data, which together help guide the patient through a customized treatment pathway.

So far, the system is equipped with algorithms to treat chronic back and leg pain, including cases of nonsurgical back pain and painful diabetic neuropathy.

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“HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care,” said D. Keith Grossman, chairman and CEO of Nevro, in a company press release.

“Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world. HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.”

The Senza HFX iQ system contains a HFX iQ Pulse Generator (IPG) that is implanted into the patient, a trial stimulator device to test the effects of neurostimulation for about a week before implantation, a charger and the HFX app that is installed onto the user’s smartphone.

The spinal cord stimulation device uses the company’s high-frequency 10 kHz Therapy platform, which has been evaluated in clinical trials and is further supported by real-world evidence from more than 90,000 implanted patients and with more than 20 million data points.

The AI-based system makes automatic recommended adjustments to the customized treatment plan based on patient inputs on the HFX app. These inputs include percent pain relief, pain score, change in activity levels and change in pain medications. The pain relief program is directly adjusted on an individual’s IPG from the HFX app without requiring a separate manual remote.

The captured patient and device data can be directly shared with healthcare providers. Nevro said this provides a connected, digital environment around a patient’s therapy that allows for future updates to the HFX algorithm and can introduce new features and capabilities for patients and providers.

“With HFX iQ, our goal is to provide physicians and patients the personalization needed to achieve and maintain the best possible long-term outcomes. We believe HFX iQ represents the future of SCS therapy,” said Grossman.

Nevro will be initiating a limited US rollout by the end of the year with expansion plans across the country next year. It is also pursuing a CE mark approval of the spinal cord stimulator in Europe.