Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system.
The company will initiate a limited release of Senza HFX iQ in the USA this quarter, with a broad US market launch planned for early 2023. In addition to this US FDA approval for HFX iQ, Nevro has submitted the technology for approval in Europe too.
Nevro claims that Senza HFX iQ is the “first and only” artificial intelligence (AI)-based SCS system that learns from patients, and was developed to address the variability in pain from patient to patient, as well as helping patients optimise and maintain long-term pain relief and improved quality of life.
The system is comprised of the HFX iQ implantable pulse generator (IPG), HFX trial stimulator, charger and HFX app, and will launch with algorithms specifically for treating chronic back and leg pain, including non-surgical back pain (NSBP) and painful diabetic neuropathy (PDN).
In a press release, the company notes that Senza HFX iQ is digitally enabled and designed to optimise care by collecting patient data and guiding the patient through a customised treatment pathway—providing several key advantages over other SCS systems, including:
- Patients start on the programme most likely to provide pain relief, based on the HFX algorithm, which was built from more than 20 million datapoints and 80,000 implanted patients
- Recommends customised therapy adjustments informed by patient inputs on the HFX app, including % pain relief, pain score, change in activity levels and change in pain medications
- Directly adjusts the pain relief programme on the patient’s IPG from the HFX app on their smartphone, without the need for a separate manual remote
- Captures patient and device data to enable sharing of patient-level outcomes with treating and referring physicians
- Provides a connected, digital environment around a patient’s therapy that will allow for future updates to the HFX algorithm, as well as new features and capabilities for patients and providers.
“HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalises care,” said D Keith Grossman, chairman and CEO of Nevro. “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 programmes 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 programme changes. HFX iQ utilises our superior high-frequency 10kHz therapy platform, which has been proven in clinical trials and is further supported by real-world evidence from more than 90,000 implanted patients. With HFX iQ, our goal is to provide physicians and patients the personalisation needed to achieve and maintain the best possible long-term outcomes. We believe HFX iQ represents the future of SCS therapy.”