In the market for Spinal Cord Stimulation (SCS), companies have been looking at different ways to extend the battery life of an implantable pulse generator (IPG) and minimize the amount of time patients spend recharging a device. One competitor that’s making advances in battery longevity is Abbott Laboratories.
Armed with its own research that showed patients do not like recharging, Abbott launched the recharge-free Proclaim Elite SCS in 2017 with a patient-centric strategy and an eye for capturing share in the US SCS market. Since then, there have been questions about battery life, and whether or not a recharge-free IPG would have to be replaced more frequently than a rechargeable SCS.
To address these concerns, Abbott recently launched the Proclaim XR neurostimulation system, a recharge-free neurostimulation system that uses the Company’s BurstDR waveform coupled with the BoldXR low dosing protocol to extend the IPG battery life without recharging up to 10 years.* Based on findings from the BOLD study (BurstDR micrOdosing stimuLation in De-novo patients), Proclaim XR uses a programming protocol designed to deliver BurstDR stimulation intermittently using the lowest effective dose and low-energy stimulation to achieve pain relief. The Company has been using this protocol in the field to program its Proclaim Elite SCS systems with good results and was confident using data from BOLD study to seek a FDA PMA supplement to change the product labeling to offer an IPG battery life up to 10 years at the lowest dose settings and a five-year battery warranty– the first ever for a recharge-free device according to Abbott.
To find out more about the Proclaim XR, its battery life, and how it’s being received in the market, SmartTRAK interviewed Allen Burton, MD, Abbott’s Divisional Vice President (DVP) and Medical Director, Neuromodulation via Uberconference from his office in Texas. Click on the following video to listen to the full interview. A transcript of the interview is also provided below.
The interview was conducted by Anne Staylor, SmartTRAK's Managing Editor,
Sr. Director of Advanced Technologies. Anne will be representing SmartTRAK at NANS 2020, July 23-26 in Las Vegas, NV. Please Contact Usif you would like a meeting!
SmartTRAK: Doctor Burton, Abbott has launched the Proclaim XR. How has it been received so far?
Allen Burton: I think our Proclaim XR has been very well received by physicians in the pain management community, and we've had many interactions with patients who have really benefited tremendously from this new neuromodulation product.
Maybe you'd just talk a little bit about it and what exactly is resonating with physicians and patients?
AB: What is most exciting is that, this is the first time that the concept of bringing the lowest effective dose into neuromodulation has really been advocated and has really been talked about and discussed widely in the neuromodulation community. So, what that really does for the patient is, it gives them this device called the Proclaim XR that, when it's implanted, controls their symptoms very effectively, but doesn't require any maintenance from the patient. It really provides them with a device that is really, what we call, hassle-free, which is kind of another of saying recharge-free. These patients get this device installed that, at the lowest settings will last them, per the FDA labeling, will last up to 10 years at these low-dose settings.
That has really previously only been seen with devices that require recharging. And with most of the more recent technology, those rechargeable devices have been recharged, in many cases, on a daily basis. So, the idea that the patients can get a device that gives them the latest technology where they don't feel paresthesia, they don't have to adjust the programming, and they don't have to really interact with the device much at all, if at all, is really unprecedented. We've heard many patient anecdotes. We had a patient come to one of the town hall meetings, who was just ecstatic. She just has her life back. She has these two teenage kids, and she can't wait to get back to just a full life, which, in her case, she's very, very active. A lot of outdoor hiking and kind of activities, and she just can't wait to get back to all that. You can just tell, she's so busy that, she really didn't have time to have chronic pain, and that it would have been a very different experience for her to have a device in that she needs to adjust or change the programming frequently, or on a daily basis say, "Oh, hold on, kids. I have to sit down and do my recharging bit." She specifically mentioned that she was excited about those attributes of the device.
Can you say how many patients have been implanted with this device so far?
AB: I can't. But we've seen it in just about every corner of the United States. We've heard positive feedback, positive stories. There's been a lot of activity on LinkedIn and other social media, people who are excited about this therapy. But I won't give any specific.
You mentioned FDA labeling. I noticed the PMA supplement called it a rebranding of the Proclaim Elite. How would you say it's different? What's its unique features compared to the Elite?
AB: What we would say is that we've had such positive experience in our last three years since Burst FDA approval with dose settings that have continued, since our initial experience with Burst, almost nine years ago now, clinically, outside of the US and then three years in the US. We've continued to really, scientifically look at our patient outcome, we've continued to do basic neuroscience with that waveform, with the BurstDR waveform, and it's continually led us toward lower and lower amplitudes, and increasing off with the therapy. Because it's a signal that was derived from endogenous neural signaling by Doctor DeRidder, a neuroscientist sort of translated the internal endogenous communication of the nervous system into this BurstDR waveform. Because of that, it has a specific potency that allows us to adjust the amplitude to very low, sub-feeling levels, where the patient doesn't feel the stimulation therapy.
And then, it allows us to add in off time. We had had such a good experience with that over the last several years with increasing off time. And 30 seconds on, 90 seconds off became our standard approach, over the last couple of years out in the field. Because the patients don't feel it turning on and off, it's very simple to institute those kind of programming changes, so all the patient feels is pain relief, and they're quite happy with that.
So, that led us with, again, the guidance of our neuroscientist, to do a clinical study that we called the BOLD protocol. The BOLD protocol was really a dose-finding protocol to find the lowest effective dose. We saw such success when doing this that we internally had this really kind of aha moment, where we felt that the entire industry had not really embraced recharge-free aspects of neurostimulation as a feature that would be as meaningful as we thought it might be. So, we really, in order to fully embrace recharge-free and not just have that added in as another feature, we're going to continually adjust our programming within that Proclaim embodiment. We decided to take our programming data and go back to the FDA, and try to get labeling for a longer life of the battery, and really show the FDA our programming data, and see what they would allow us to do in a promotional way.
The Proclaim XR is, in most aspects, is the Proclaim battery, but what it has is, importantly, is the FDA approval for us to discuss openly and for us actually to offer, now five-year battery warranty on the battery life of the Proclaim XR feature. The FDA has looked at that very critically, and they even allow us to talk about the battery lasting up to 10 years at low-dose settings. So, we're super excited about this. I think doctors have always liked the idea of recharge-free neurostimulation, but there's always been a dark side to that cloud, that has said, "Well, but the battery's going to wear out really quickly, and we're going to end up spending a lot of money and having a lot of repeated surgeries replacing these batteries that ..." And then, fill in the blank. The competitors say at a year, two years, two and a half years, these batteries are all going to get replaced, and it's going to be a huge expense, and the patient's going to have to go through surgery unnecessarily, and so on.
But with the rechargeable cells, you can get up to 10 years longevity with a rechargeable cell. For us to actually be able to have those same life parameters on a device that never needs recharging, we felt that it was really worthwhile for us to take that to the FDA, our new programming data, and show them our preserved efficacy with lower doses, and that allowed us to offer a warranty claim where the other companies now have to say, "Well, okay ..." So, it makes our long-life claims credible, the fact that we're offering a five-year battery life warranty. We felt that the differences in the Proclaim XR system are really in the programming aspects of it. And then, those programming aspects are also in the peripheral and iOS programming system, and capability. How the programming looks and how it guides the patient and the programming to the lowest effective dose, in terms of on it.
The differences are in the programming aspects, are in the low intermittent dose programming aspect. And the embodiment of those are in the software and are in the patient controller, for example, and how the patient controller and the clinician programmer guides the therapy to the lowest effective dosing. That's where the changes largely lie in that, as well as in the branding and the FDA approval to say up to 10 years of battery longevity.
So, if I have a Proclaim Elite already, can you program it to be like the XR? Or do I have to wait to have an XR?
AB: This is a feature that we've always talked about with our devices, and because of our iOS platform, we've been quite excited about upgradability. The features that come in the XR can be upgraded into the existing Proclaim batteries that patients have out there. In fact, we've largely done that. We've had such confidence in our ability to lower, well, their amplitude or intensity of stimulation, as well as increase our off time, because we had been using some of those programming feature sets in the existing Proclaim batteries. So, we have a strong degree of confidence in the Proclaim XR. The Proclaim XR comes with those default settings in it, but patients who have Proclaim Elite batteries in place can be programmed into the BOLD XR protocol.
Now, you mentioned five-year warranty, and then 10-year battery life. What is the big difference with that?
AB: The big difference in that is, in the BOLD study, which will be presented again at the upcoming ASRA meeting, and then the final dataset of the BOLD study will be presented at NANS, and is in review right now. It's not published yet. But the results of that study show us that about half the patients in the dose finding are programmed onto the lowest settings, and the lowest settings currently are 30 seconds on, and then six minutes of off time. At that setting, we project the battery life to last, really, 10 years, or even longer than 10 years, in many cases, depending on the exact impedance of the lead. So, that's with 50% of the patients. Now, the standard setting, the starting setting, if you will, of the BOLD protocol, is 30 seconds on and 90 seconds off, or one and a half minutes of off time. With that setting, which is, we'll say, the highest dose within that dose finding, the patient's battery life will be, we don't believe it will be 10 years, but again, depending on the lead impedances, it will be between five and 10 years. And in some cases, depending on the exact settings and the lead impedances, and so on, it may be more like six years. In some cases, it will be more like seven or eight years.
It will be within that range, but again, we think that all the patients will see battery life that is really unprecedented in terms of recharge-free neuromodulation systems previously. But we really like that the FDA came out and said that we can use the 10-year claim at the lowest dose settings. And again, we're confident that we saw that in half the patients, so that's why there's a difference between saying that, that when we say 10 years, we always say up to 10 years. We really aren't saying, "Oh, you'll get 10 years with this device." And if you listen closely to the rechargeable competition, they have language that's very similar to that, when they speak about their battery life.
Well, that's what I was going to ask you. I was going to say, I see that on those product information brochures, up to. And even on the rechargeable, I think the highest is, what, 10 years? Isn't it? Or-
AB: I think that's ... Yeah, that's absolutely right. This is the first neuromodulation system that offers a battery life warranty in the market. Other products are warrantied, but they're warrantied for other attributes of the product, like defects in connections, or internal devices, or a part of the chip set, or other aspect leads, and so on. But not for battery life. This is the first device actually to offer a battery life warranty in the space.
That's really important, because I'm sure that's reassuring to people, and certainly, when you have competitors out there trying to say different things about your device, that's something that you can point to, right?
AB: They say, putting your money where your mouth is, right? Or making the claim more believable. Doctors say, "Well, you say it's going to last that long, but how can we be confident, or how can we be reassured?" And there was a lot of internal discussion, as you can imagine, that having a warranty would really reassure patients and physicians that we stand behind the product, and we stand confidently behind those longevity claims.
Part of the reason I'm asking so many questions about the device is because, when I report, I have a product profile, and I have one on the Proclaim Elite, so I wasn't sure if I should just change it to Proclaim XR. Are they going to have Elite as part of the profile? Will it be retired? Or--
AB: In regulatory markets where the Proclaim XR is approved, because FDA approval was obtained for Proclaim XR, that became the only available Proclaim product in the United States, right after FDA approval. But still, in Europe today, for example, or in certain countries where the CE mark hasn't happened yet, the Proclaim Elite is still being sold and utilized until that approval is obtained.
How far away do you think that will be? Do you have any idea in Europe when you'll come out with it?
AB: We anticipate that soon. I'm not going to get more specific.
What about digital initiatives? Last time I talked to you, Doctor Burton, we talked a lot about where Abbott's going. In terms of the Proclaim XR, is it going to be able to allow you to track usage settings, all those things that we talked about? Or is that doing that now? Or where and when will that be available?
AB: Yeah, those are great questions, Anne. Our digital health team is making good progress. This device is on, as the Proclaim Elite was, this device is on an Apple iOS platform, which allows it seamlessly to integrate into what our digital health team is working on. So, we think, again, there's not a specific release date, because some of it is in the regulatory process, but we would say within 2020, we will begin to have some of our digital health offerings will begin to come into the marketplace, and there will be a number of different pieces to that, like we've talked about. Some of them will involve the patient being able to engage with their health care team through the iOS platform, through the Apple platform, and through a digital ecosystem. Some of it will be patient tracking of their outcomes. How is the patient doing? And some of it will involve the patient being able to troubleshoot their device, or being able to get in contact with technical support help if needed. And then, there will be other offerings to the device and things like educational modules, or frequently asked questions, or sort of simple things like that.
But all of those are doing very well. The Proclaim XR is very digitally-friendly. Those features are not activated yet. The promise of a digital ecosystem interacting with an implantable device, and being in the Cloud, and the doctor having access to that, and the patient having access to it, we're very capable of all those things right now, but there's a tremendous amount of technical caution and care needed to shepherd those through the exact regulatory process that's needed, mainly for the reasons of cybersecurity and patient confidentiality, HIPAA. I would say HIPAA and cybersecurity are the most critical aspects of that to absolutely get that 100% right. So, we've been in communication with the FDA. I think both our neuromodulation team, digital team, as well as Abbott digital teams have had both public and private meetings with FDA on topics like cybersecurity, and on topics like digital health. Abbott's been rolling out products in the diabetes arena that involve digital health. So yeah, we're on track for 2020 to be a very exciting year for our digital health program within neuromodulation, and it will be exciting. Our devices, it will only enhance the patient-centric nature of our devices. It will just expound on that. It will almost be more futuristic, in a sense. It will just enhance that.
So, the Proclaim XR and all the implanted devices, now, the Elite, are those ready to just be upgraded to take advantage of these digital initiatives, then?
AB: Oh, absolutely. When our digital health programs begin to roll out, the fact that we've had these on an iOS platform will be very important for us as we're moving into this, that patients won't have to get a new device to access those features, that there's an upgradable capability within our devices, so that's engineered in already. These devices are on Bluetooth. Many implantable devices, when a patient has to communicate with the device, they have to put a sensor directly over the skin, or put an adhesive on, or have a hard time, sometimes, pairing or bonding with that internal device. We use the iOS platform so the patients holding an Apple device, and they're communicating with Bluetooth into their device. So, we have a lot of the pieces in place to do this very seamlessly when it happens. But again, it needs to be done with great care, because of the cybersecurity and just the idea of the digital ecosystem, and having patient-implanted devices in the Cloud, and having that happen.
Once that starts happening, we're going to wonder how we worked without it, much like many technological hurdles that have happened around the world. But getting to the point where we're ready to go with that takes a lot of engineering and technical expertise, and a lot of digital expertise, and a lot of care and interaction with the regulatory authorities. So, all that's kind of happening behind the scenes right now, but it's full speed ahead.
Very exciting. You know, you and I, last time, you were really good. We talked a lot about the market, the spinal cord stim market slowing down. And certainly, gaps in innovation, I think, for companies have been part of that. So, in the market, as far as Proclaim XR, do you feel like Abbott is going to be gaining traction, get a competitive edge? Can you give me any kind of idea how well it's doing, or where you think it will go?
AB: I do think that this device has really brought patient centricity back into the discussion, and I think, when we have seen doctors ... qnd we've seen quite a number of doctors who either previously largely used other products, other competitors' products, and have made a move to us to really avail their patients of a more patient-centric approach. And when we've had conversations with those doctors about, why did they make that choice? Or when we've had patients who've had a failing device that has required maintenance, has require frequent adjustments and recharging frequently, and when they've been changed to our device, we've learned a lot from talking to both of those groups. And both of those groups are so excited about the really patient-centric aspect of this device, that it largely just functions with so little input and feedback from the patient, that they're super pleased about it.
And one of the things that maybe is different with this launch than previous, maybe, let's say attempts at this, are that we've really quantified that patient experience more. We've put that really at the center of this. The whole idea that we went back to FDA and got the ability to really openly discuss, how long is this battery going to last? And to get this patient-centric approach, it would be like getting an iPhone, let's say, that never needs recharging. And you'd say, "But I need to know how long it's going to last before I buy in to that. I realize, I won't miss recharging my phone, but I need to know it's going to work." So, in order for us to go back to the FDA, get the ability to get approval for that, be able to say it, warranty it, if you went and bought a phone you didn't have to recharge and they said, "Well, okay, we'll warranty it for at least five years," I'd feel pretty good about that. I'd just get one tomorrow and I’ve heard this conversation echoing what some of those people have told me, patients and doctors.
But the other aspect of this is that they're sharing a lot of these stories, now, on either social media, or directly with other family members, or patients who have rechargeable devices are asking about it, they're sending us messages through social media. There seems to be a lot more interaction. It seemed that, with other products, or other technological advances that we've seen, we've interacted more with doctors. And I think, because this is so patient-centric and so meaningful to patients, I think maybe the patients are getting more involved in the choice, and maybe they're being a little bit more vocal about it through some of these social media opportunities. So that may be bigger than previous iterations, and just the three, or whether you include the fourth company, us all trying to grab each other's market share, this may push outside of those boundaries because we're having more patients involved in the conversation, and they're pushing conversation into different venues where it hasn't been before.
I know we don't have much time left. I know that they presented four-month BOLD study results at INS and you said the next iteration's coming at ASRA and then at NANS. Is there any other research that you're working on on the Proclaim XR, micro-dosing, habituation, any other studies or registries, or anything I should be aware of?
AB: Yes. There's a study called the TRIUMPH study. It's a two-year outcome study that has several hundred patients in it, and it's a long-term, really a registry study on the use of Burst DR. The TRIUMPH has a sub-study in it, now, where patients have been programmed into the BOLD's protocol to get more long-term data, and those results will be probably available at the WIT meeting, which will be in Rome. But there will be a bigger cohort of longer-term BOLD results that'll be presented. So yeah, we have a natural cadence, we started with a study called the BOSS study, which was a low-dose study in Germany, then the BOLD study followed that. Now, we're going to program a larger set over a longer term in TRIUMPH, in a prospective study. All of our studies going forward, there will be another study called REALITY that'll have like 2,000 patients in it, followed for five years. And all of the Burst patients in that will be programmed in the BOLD protocol. We will continue, over time, to have more and more studies, and longer-term follow ups, and bigger cohorts of patients programmed into this mode as we go forward.
So, REALITY, when does that start?
AB: REALITY's already started. And what the current enrollments are in REALITY, but maybe let's say out of 1,000, maybe it's 10% enrolled already, something like that. So, it's cooking.
I talked to Keith a while back about some RF ablation technology. Is Abbott still on track for that in 2019? Or how far away do you think that will be? Do you have any idea?
AB: The RF Generator will be in 2020, it won't be in 2019. I can confidently say that. And I'm not going to give you the date on that, but it's going to be super exciting. We're making good progress, and we're excited about the RF space. We have a small clinical study going on in RF. We'll be doing more clinical studies as the new device comes out, and we're really excited about that therapy. The real RF studies that we're planning are going to be done with the new Generator, so they're going to be a companion with that. That will be-
I see. So, the one that you're studying right now doesn't have the new generator, or it does?
AB: No, what we're looking at right now are just some basic outcomes. The study we're looking at now is just a data gathering. It's a little bit of a retrospective chart review on some basic RF procedures, and just looking at some basic RF outcome data. The more exciting studies will be companion with the new box, when the new RF Generator comes out next year.
Anything else? What's next in terms of innovation for Abbott? Anything else you can share?
AB: No. I mean, gosh, I think that's enough right now. I mean, digital-
Yeah. You do have a lot going on.
AB: The new RF Generator in 2020. I think we're going to see more excitement as Proclaim XR gets approved in other countries. And I think having this lowest effective dose neuromodulation therapy with Proclaim XR really taking global footprint in 2020, I think, will be just super exciting to see what we can do with that.
All right. Well, thank you so much for your time.
AB: You, too. Thanks.
*Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. NOTE: In neurostimulation therapy, ‘dose’ refers to the delivery of a quantity of energy to tissue. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. Refer to the IFU for additional information. Hassle-free means recharge-free.