Nevro has received US Food and Drug Administration (FDA) approval for its Senza HFX iQ spinal cord stimulation (SCS) system to treat chronic pain.
The Senza HFX iQ SCS system has been developed for addressing the variability in pain from patient to patient and to optimise and maintain long-term pain relief, as well as improved life quality.
It includes the HFX Trial Stimulator, HFX App, HFX iQ Implantable Pulse Generator (IPG), and Charger.
The digitally enabled device will be introduced with algorithms that are specifically developed to treat chronic back and leg pain, along with non-surgical back pain, as well as painful diabetic neuropathy.
It is intended to optimise care by collecting the patients’ data and guiding them through a personalised treatment process.
Senza HFX iQ is claimed to be the first and only SCS system that uses Artificial Intelligence (AI) for optimising and maintaining pain relief using the response of a patient.
Nevro chairman and CEO D Keith Grossman said: “HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalises care.
“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 10 kHz Therapy platform, which has been proven in clinical trials and is further supported by real-world evidence from more than 90,000 implanted patients.”
The company noted that Senza HFX iQ offers several advantages over other SCS systems.
It recommends customised therapy adjustments based on patient inputs on the HFX App, which include pain score, pain relief percentage, change in activity levels, and pain medications.
Senza HFX iQ can directly adjust the pain relief programme on the IPG of a patient, through the HFX App, without requiring a separate manual remote.
The system gathers patient and device data for sharing patient-level outcomes with treating and referring physicians, and also offers a connected, digital environment around a patient’s therapy.
Nevro intends to release the Senza HFX iQ system at limited scale in the US this quarter and has plans to launch across the nation early next year.