Nevro Corporation announced today that it has now initiated the full US market launch of its HFX iQ spinal cord stimulation (SCS) system, following the completion of a successful limited market release.
“This is an exciting time in spinal cord stimulation—better waveforms, more conditions we can treat, and a massive treasure trove of patient data,” said Usman Latif (University of Kansas Medical Center, Kansas City, USA). “The way forward in this field is precision medicine powered by big data and artificial intelligence [AI].”
HFX iQ starts patients on the programme most likely to provide pain relief, based on Nevro’s HFX algorithm, which was built from more than 20 million datapoints and 80,000 implanted patients. It combines clinical inputs, such as pain relief and pain score, along with quality-of-life inputs like pain medication and activity level changes to provide an individualised programme setting for each patient.
According to a Nevro press release, the system offers both low frequency and the company’s proprietary high-frequency 10kHz therapy, which represents “the widest range of frequencies of any SCS system on the market”. The company’s Senza high-frequency 10kHz therapy has been validated in both clinical and real-world outcomes, and offers unique, AI-driven iQ modes specifically for treating painful diabetic neuropathy (PDN), and chronic back and leg pain, including non-surgical back pain (NSBP).
“Our limitations are human in nature,” Latif continued. “What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programmes worked and what did not, and bring the power of all that knowledge into the palm of our patient’s hand—with them 24/7, monitoring them, and offering them the best programme for their exact situation with a tap on the screen? HFX iQ is the future of medicine, where expanded data hold the promise of new capabilities and improved care.”
The Senza HFX iQ system is comprised of the HFX iQ implantable pulse generator (IPG), HFX trial stimulator, and HFX app. With a new Bluetooth-enabled IPG that is upgradeable and connects directly to the HFX app, each patient can input assessments into their smartphone and then receive programming adjustments in real time, the release adds.
In addition to this approval for Senza HFX iQ, Nevro has also submitted for approval in Europe and Australia.