When a patient walks into Dr. Jason Yong’s clinic at Brigham & Women‘s Faulkner Hospital complaining of pain, his work has just begun.
“Pain is a common symptom and it’s totally generic,” Yong explained to MassDevice. “The other thing that makes it challenging is that it’s so subjective.”
After Yong exhausts the pharmaceutical possibilities for managing his patient’s pain, he turns to technological options such as implantable neuromodulation systems.
Neuromod devices use electrodes to deliver stimulation directly to a patient’s brain, spinal cord or peripheral nerves, inhibiting pain signals or triggering neural impulses. Although commonly associated with managing pain relief, neuromod systems are used to treat an array of conditions, including Parkinson’s disease, incontinence and vascular disease.
“This is a defining moment in neuroscience: for the first time, we are using the ‘language’ of the nervous system to alter its responses. We can now pinpoint pain signals and deliver personalized therapy,” the medical director for Abbott’s neuromod business, Dr. Allen Burton, said in a statement.
The global market’s appetite for these systems shows no signs of slowing down – it’s expected to grow from $8.4 billion last year to $13.3 billion in 2022, according to Neurotech Reports.
“I’ve been in this space for 14 years and in the first 10 years of my career, we really only saw incremental innovation related to hardware or devices, such as increasing the number of electrodes on leads or adding components such as accelerometers and MRI compability,” Boettiger said. “All these things are interesting and can take the technology forward, but none of them had clinical data to support their use and none of these advancements were specifically designed with the patient in mind.
“It was really more about being competitive in the market in the doctors’ eyes versus actually creating better efficacy long-term for the patients with these devices,” he added.
Abbott, which has a number of FDA-approved neuromod systems on the market, decided to rethink how it went about creating these products.
“We sat down in 2013 and we changed our philosophy of how we were going to develop products and we took really this people-centered, patient-centric philosophy around development,” Boettiger said.
As an example, Boettiger pointed toward rechargeable neuromod systems, which were all the rage in the mid-2000’s.
“People sunk a lot of money into rechargeable devices because everybody thought that the longer the battery lasts in the patient, the better. That was the philosophy, but there was no data to support that,” he said. “That was driven by physicians saying, ‘I don’t want to have to manage patients needing a device replacement, so the longer the battery can conceivably last, the better.'”
After surveying the market and studying outcomes, Abbott discovered that the rechargeable systems were being removed from patients at twice the rate as their non-rechargeable counterparts.
So the company moved to a recharge-free platform for its neuromod systems. Abbott was aiming to develop a system that would require minimal interaction, similar to a cardiac pacemaker.
“We drew the conclusion that these devices are going to be better for patients if we’re not drawing attention to their device every day by having them recharge, by giving them a medical grade patient programmer that they pull out of their purse or they pull it out of their pocket and people are staring at them and trying to figure out what’s wrong with them,” Boettiger said. “What was better for the patient was to receive a system they never had to recharge, that would last for years, and that managed their pain in a way they rarely had to think about.”
From a doctor’s point-of-view
To treat his patients’ pain, Yong uses what he calls a “step-wise approach.” First, he will try pharmaceutical interventions, like non-steroidal anti-inflammatories, even if medicines haven’t helped in the past for a particular patient.
“As we exhaust all these other steps, we may start to think about the implantable devices. We don’t like to implant a device in someone if we can avoid it, so we will exhaust every single step,” he said.
“I think the biggest part of our job is expectation management. So I tell them that, ‘Listen, we’re not going to get you to zero. We’re looking to reduce [the pain] by 50% at least, and make you more functional.’ So that’s our primary objective, is to make you more functional, to get you through this, not to take away your pain, just to reduce it and manage it.”
After a patient has qualified for an implantable device to manage their pain, Yong takes them on a trial run with the system for seven days. More than 80% of people who try neuromodulation experience a reduction of pain worthy of a more permanent implant at his clinic.
“For the patients that we are able to help, they are very happy with it,” he said.
For some patients, the pain relief they experience during the trial run is not enough to justify the risks of the implant procedure.
“You get the patients that are like, ‘I feel 30% better. I want it in,’ and you have to tell them no. That’s a difficult conversation to have with them,” Yong said.
Tackling the opioid crisis
The history of pain management in the U.S. is complicated and nothing has made that more clear than the staggering statistics linked to the opioid crisis. More than 115 people die every day from opioid overdoses, according to the Centers for Disease Control & Prevention.
Both Abbott and Yong see neuromodulation as one way to help get the crisis under control. In January of 2017, Abbott touted data from a 5,400-patient study evaluating daily opioid use following spinal cord stimulation therapy in people with chronic pain. The researchers found that average daily opioid use declined or remained steady in people with a spinal cord stim device. People who had the device removed experienced greater opioid use over time.
“We’re seeing that it’s moving the needle on reducing the overall doses of the opioids on these patients. Not many patients. We do have some patients with the neuromodulation systems, but not many, where they will come completely off. But if you’re able to reduce it quite a bit, then that has a big impact on the epidemic as well,” Yong said. “So, I do see neuromodulation as helping to reduce the overall burden of opioids in society for these people who are these complicated, refractory patients. I’m not saying that this is the answer to the opioid epidemic, but I’m saying it’s part of the answer for part of the problem.”
Ryan Lakin, Divisional VP of R&D with Abbott’s neuromod unit, agreed.
“People living with chronic pain are now more than ever able to resume normal and healthier lives thanks to neuromodulation systems using Apple iOS, Bluetooth connectivity and familiar consumer tech. These non-opioid treatments allow people to better manage their disease and focus on living full lives, pain free,” he said in an emailed statement.
Compared to his early days within the industry, Boettiger predicted that Abbott will continue to rely more heavily on long-term clinical data and the patient perspective to support its product development efforts.
“I think the appetite now is much higher for clinical evidence, not only for clinicians and patients but for payers. For these devices and for this space to be successful long-term, you’re going to have to invest in the clinical research to support the innovation that you’re doing,” he said.
Yong said he also wants to see more rigorous clinical studies for implantable neuromod devices but added that those studies should be independent of the companies creating the products.
“In an ideal world, I think we should be taking the funding out of the device company’s burden and putting it under some other funding source that’s a little bit more objective. I think it’s a problem inherently in research that there is bias based off of what the funding source is,” said Yong, who reported no conflicts of interest with Abbott.
“Right now it’s really tough to get that kind of funding because it’s so expensive to run these trials. Especially when we’re talking about an implantable device. So I don’t think that’s a reasonable or realistic way to do it, but in an ideal world, that’s what we would be doing, is doing a completely unbiased design of these studies,” he said.
It would be helpful to have a registry of all the outcomes associated with implantable neuromod devices, Yong added. Observing patients in his own clinic, he’s seen the tangible relief delivered by updated neuromod systems.
“With some of the newer systems, we’re seeing more robust and durable relief and we think maybe that’s because of what we’ve learned from previous patients,” Yong said. “It’s an exciting time to be in neuromodulation.”