Nevro, a US-based medical device maker focused on chronic pain treatment, has received the US Food and Drug Administration (FDA) approval for its Senza HFX iQ spinal cord stimulation (SCS) system.
The Senza HFX iQ system comprises the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, Charger and HFX App.
It will run based on algorithms created explicitly for treating chronic back and leg pain, including non-surgical back pain and painful diabetic neuropathy.
Senza HFX iQ is a digitally-enabled device, designed to optimise care by collecting patient data and guiding the patient through a customised treatment pathway.
Nevro said that the device had been developed to address the variability in pain from patient to patient and to help them optimise and maintain long-term pain relief.
Senza HFX iQ is the first and only SCS system that leverages Artificial Intelligence (AI) to optimise and maintain pain relief using patient’s response, said the company.
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 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 with the personalisation needed to achieve and maintain the best possible long-term outcomes. We believe HFX iQ represents the future of SCS therapy.”
Senza HFX iQ is said to offer several advantages over other SCS systems, including the HFX Algorithm that was built on more than 20 million data points and 80,000 implanted patients.
The system recommends customised therapy adjustments based on patient inputs on the HFX App, including pain relief percentage, pain score, change in activity and medications.
It can directly adjust the pain relief programme on the patient’s IPG, through the HFX App, without requiring a separate manual remote.
Senza HFX iQ gathers patient and device data to share patient-level outcomes with treating and referring physicians and offers a connected, digital environment.
Furthermore, the company intends to release Senza HFX iQ at a limited scale in the US this quarter, with a nationwide market launch planned for early 2023.
