Sam Brusco, Associate Editor03.10.23
Nevro, a company developing solutions to treat chronic pain, has begun full U.S. market launch for its HFX iQ spinal cord stimulation (SCS) system following completion of a successful limited market release.
The company began the limited market release after FDA 510(k) clearance late last year.
"This is an exciting time in spinal cord stimulation—better waveforms, more conditions we can treat, and a massive treasure trove of patient data," Dr. Usman Latif, MD, MBA, a Harvard-trained interventional pain specialist who practices at the University of Kansas Medical Center, told the press. "The way forward in this field is precision medicine powered by big data and artificial intelligence. Our limitations are human in nature. What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, 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 program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."
HFX iQ begins patient on the program most likely to offer pain relief, based on the HFX algorithm built from over 20 million datapoints and 80,000 implanted patients. Patients used a Senza, Senza II, or Omnia device offering 10 kHz. HFX iQ combines clinical inputs (pain relief and pain score) along with Quality of Life inputs (pain medication and activity level changes), to offer an individualized program setting.
It provides both low-frequency and the company’s high-frequency 10 kHz therapy. The Senza high-frequency 10 kHz therapy has been validated in clinical and real-world outcomes, and provides AI-driven iQ modes to treat painful diabetic neuropathy and chronic back and leg pain—including non-surgical back pain.
"We are continuing to lead the way with the first big data-backed, AI-powered SCS system that gets smarter over time, learning from patient responses to deliver personalized relief to patients," said D. Keith Grossman, chairman, CEO, and president of Nevro. "With over 10 years of innovation and now over 100,000 patients served, Nevro brings the next big advancement to SCS therapy with HFX iQ, a system that will apply the big data we have collected over the last decade to help patients find pain relief faster, and maintain that relief over time. We believe that what we're doing with HFX iQ is the future of SCS therapy, and keeps Nevro firmly at the forefront of innovation, as we continue to work with our clinicians to bring new technology, new data and new indications to their patients."
The Senza HFX iQ system is made up of 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, patients can input assessments into their smartphone and receive programming adjustments in real time.
The company began the limited market release after FDA 510(k) clearance late last year.
"This is an exciting time in spinal cord stimulation—better waveforms, more conditions we can treat, and a massive treasure trove of patient data," Dr. Usman Latif, MD, MBA, a Harvard-trained interventional pain specialist who practices at the University of Kansas Medical Center, told the press. "The way forward in this field is precision medicine powered by big data and artificial intelligence. Our limitations are human in nature. What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, 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 program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."
HFX iQ begins patient on the program most likely to offer pain relief, based on the HFX algorithm built from over 20 million datapoints and 80,000 implanted patients. Patients used a Senza, Senza II, or Omnia device offering 10 kHz. HFX iQ combines clinical inputs (pain relief and pain score) along with Quality of Life inputs (pain medication and activity level changes), to offer an individualized program setting.
It provides both low-frequency and the company’s high-frequency 10 kHz therapy. The Senza high-frequency 10 kHz therapy has been validated in clinical and real-world outcomes, and provides AI-driven iQ modes to treat painful diabetic neuropathy and chronic back and leg pain—including non-surgical back pain.
"We are continuing to lead the way with the first big data-backed, AI-powered SCS system that gets smarter over time, learning from patient responses to deliver personalized relief to patients," said D. Keith Grossman, chairman, CEO, and president of Nevro. "With over 10 years of innovation and now over 100,000 patients served, Nevro brings the next big advancement to SCS therapy with HFX iQ, a system that will apply the big data we have collected over the last decade to help patients find pain relief faster, and maintain that relief over time. We believe that what we're doing with HFX iQ is the future of SCS therapy, and keeps Nevro firmly at the forefront of innovation, as we continue to work with our clinicians to bring new technology, new data and new indications to their patients."
The Senza HFX iQ system is made up of 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, patients can input assessments into their smartphone and receive programming adjustments in real time.
