Nevro, a medtech company based in California, has developed the HFX iQ spinal cord stimulation system, which is intended to treat chronic pain. While spinal cord stimulators can be very useful in controlling certain types of chronic pain, at present, patients must attend with their clinician to obtain adjustments to their stimulator. This is inconvenient for both patient and clinician alike.
Another common difficulty is the need for frequent adjustments. Pain is subjective, and a patient’s needs can vary from day to day, but such frequent changes in spinal cord stimulator settings are not typically possible. To address this, Nevro has created the HFX iQ spinal cord stimulation system, which can suggest adjustments to the patient, and allow them to make the adjustment themselves, to better manage their pain. The system generates its suggestions based on artificial intelligence, whereby the technology learns what works best for each patient as it goes.
See a video about the technology:
Medgadget had the opportunity to speak with Claire Smith, Vice President of Global Strategic Marketing at Nevro, about the technology.
Conn Hastings, Medgadget: Please give us an overview of spinal cord stimulation and the patients who benefit from it.
Claire Smith, Nevro: Spinal cord stimulation (SCS) blocks pain signals from getting to the brain by quieting nerves in the spinal cord. The patient undergoes a temporary, fully reversible trial procedure and if successful, an implantable pulse generator is implanted just below the skin in the patient’s back during a minimally invasive procedure, where leads are then placed in the epidural space of the spine. This approach has been around for decades to alleviate debilitating chronic pain. Common areas of chronic pain that have good evidence for SCS include the trunk, back, and legs.
Nevro’s SCS, HFX, uses very mild imperceptible pulses at a high frequency (10 kHz) to quiet the pain-causing nerves. HFX is the only SCS approved to provide 10 kHz therapy. Unlike other SCS brands, HFX is a paresthesia-independent treatment that relieves pain without the sensation of tingling, pins, and needles. This differentiator is especially important for people living with painful diabetic neuropathy (PDN) who are already experiencing the discomfort of tingling sensations. HFX was FDA approved in May 2015 for the treatment of chronic back and leg pain, including claims of superiority over traditional SCS treatment. It was also the first SCS to be approved to treat PDN in 2021. Late last year, a new iteration of HFX – HFX iQ – was approved, and it’s the only true AI-based spinal cord stimulator that gets smarter over time by learning from patient responses.
Medgadget: How are spinal cord stimulators currently adjusted to better meet patient needs? Why is this suboptimal?
Claire Smith: Currently, if a patient needs their SCS settings changed, they physically go into their physician’s office to have their device manually adjusted. These frequent in-person visits are inconvenient and time consuming for not only the patient but also for their healthcare provider. It’s also important to remember that pain is subjective, and it varies by the day. This makes it difficult to accurately reprogram settings that will work for the patient long-term.
This gap in care is why Nevro dug into the millions of data points gathered from more than 80,000 patients to understand how to optimize pain relief for a specific patient at a specific moment in time, all through the use of big data and patient experience inputs. HFX iQ was designed to reduce unnecessary doctor visits and improve the experience and quality of care that patients receive. We’ve always had a goal of gathering and using data to improve the experiences of patients, so they can get back to living a life without pain, and for providers, so they can get back to doing what they do best – helping more patients.
Medgadget: Please give us an overview of the HFX iQ system and how it works.
Claire Smith: HFX iQ is the only AI-based SCS that gets smarter over time by learning from patients’ responses, to optimize and maintain long-term pain relief. HFX iQ is comprised of a smartphone app, a Nevro HFX implantable pulse generator (IPG), and artificial intelligence (AI) that is combined with Nevro’s vast database to predict pain relief as unique as the person using it. The app will ask about a patient’s pain score, percentage of pain relief, activity level, and medications, so it can recommend settings best equipped to provide maintained, optimized relief. HFX iQ uses AI to sort through millions of data points that Nevro has collected from the past decade to recommend SCS programming solutions most likely to provide pain relief at that moment, for that specific person. We think of it as truly humanized pain relief because the system listens and learns from individual patient inputs.
While all SCS devices can be programmed in a doctor’s office, HFX iQ listens, learns, and applies therapy adjustments from anywhere. Once recommendations are accepted by the patient, HFX iQ directly updates the patient’s device settings in real time, offering patients relief that adapts as pain changes – again, because we know pain is ever-changing. This is truly a critical aspect of pain management that is often overlooked.
Medgadget: How did the idea for the system come about? What inspired you to turn to AI?
Claire Smith: HFX iQ was developed with a single purpose: to enable humanized, smart, pain relief solutions to optimize and maintain pain relief over time. We’ve been collecting data points from our patients for over a decade, knowing that the more we understand about pain relief, the better we can adjust our therapies to better meet patient needs. The challenge we were facing is the fact that millions of data points are a lot to bite off and chew, so we leveraged artificial intelligence to help us sort and learn from our vast pool of big data. It’s been instrumental in helping us utilize the information we have about what works and what doesn’t to help improve patient outcomes.
Medgadget: How has the system performed to date? How have patients found it?
Claire Smith: We’re a data-driven company at our core. It’s what has allowed us to get to where we are today, and it will continue to be a center stone of who we are, and it’s what we use to measure success. We often say “follow the data” because the proof is in the evidence.
In real-world use of HFX iQ, 87% of patients reported moderate to significant improvement in symptoms, 92% of patients preferred using a digital patient interface to adjust their therapy over more frequent programming calls, and 82% of patients were satisfied or very satisfied with using the patient interface to make therapy adjustment. Since HFX iQ’s development, we have continued to monitor and review data in order to understand future updates needed to the algorithm to maximize time to relief and maintain relief over time.
Anecdotally, we’ve heard that iQ is a game changer for patients. Patients feel in control when they use HFX iQ and that they finally have a therapy option that is 100% custom to them. We are extremely proud of the response to HFX iQ so far and are looking forward to further refining the platform as we always seek to continuously improve.
Medgadget: What role do you see AI playing in healthcare in the future? Do you envisage other such technologies where AI can provide tailored responses in real time?
Claire Smith: I believe that artificial intelligence will continue to play a major role in the future of healthcare, but it won’t be a “be all end all” solution. AI allows us to be more efficient, but AI should never replace humans, especially in healthcare. I see it as a support tool for human decision-makers and I think it will remain as such as companies look to leverage it in healthcare innovation. I see a role for it in diagnostics, especially when you think about rare diseases when doctors have less familiarity with conditions that aren’t as well-known and studied. As we learn more about AI and learn how to improve it, I think we’ll continue to see new and improved advances in care. After all, it’s our responsibility as innovators to identify how to improve lives for patients, and if big data can help us get there faster, it’s a win.
Link: Nevro homepage…