Allen Burton is changing planes at O'Hare Airport and, as anyone who's made the ride along the moving walkway in Terminal 1 knows, George Gershwin is his traveling companion for at least this part of his journey.
The infinite loop of Gershwin’s "Rhapsody in Blue" that aurally connects Concourses B and C is perhaps the perfect musical accompaniment for this conversation.
After all, when "Blue" debuted to the world in 1924, it was revolutionary for an age defined by invention: Jazz. Contemporary reviews hailed it not as one idea, but rather several correlated, combined and contrasting rhythms stirring hardened concertgoers with the sensation of a new voice. Retrospective reviews decades on, including by Leonard Bernstein, hailed a composition that you can cut parts, interchange sections, add new cadenzas — packets of music, tailored to your tastes, if you will — and it’s still "Rhapsody in Blue."
Burton, medical director of Abbott’s neuromodulation business, and his team have orchestrated their own sit-up-and-take-notice piece.
Like "Blue," Proclaim Plus spinal cord stimulation (SCS) with FlexBurst360 builds on the revolutionary advancements offered by BurstDR. Rather than tonic treatment — in SCS, simply speaking it's the idea of a consistent and constant pounding of electrical impulses that can leave a person with an unpleasant tingling — the key and the clue to the BurstDR invention is in its name. Bursts — or packets of electricity, tailored to your needs, if you will again — are coordinated and correlated rhythms of pain relief to multiple sites in the body that can stir hardened feelings from years of living with pain with the sensation of a new possibility: The potential for living without severe pain. Program it how you need, it's still Proclaim Plus, still FlexBurst360, still BurstDR.
For people living with chronic pain, Proclaim Plus is the opening clarinet's signature siren call that something “truly special,” as Burton describes it, is about to wash all over you.
Are we rhapsodizing? Guilty. But you'll see why by the end.
Burton has a flight to catch and we have an overhead bag full of questions to get answered about this new technology before he takes off. Edited for length and clarity.
Abbott: What's driving Proclaim Plus?
Burton: The new software that powers our latest in developments in BurstDR therapy, which we're calling FlexBurst360. That's the important addition.
What's the software's design inspiration?
Our BurstDR stimulation mimics the body's signaling with packets of bursted energy.
Tell us more?
There are stacked charge pulses, one on top of each other. Then there's a passive reset interval. That very special neurophysiologic characteristic makes it resonate in the nervous system.
And that's better than tonic how?
Because those characteristics mimic internal bursted signals, BurstDR provides superior pain relief.
Yeah, that is good. Other benefits?
It's effective therapeutic stimulation at a much lower amplitude than tonic stimulation, which makes it below the sensory threshold, so patients don't feel it. And that's one of the hallmarks of BurstDR stimulation compared to tonic, all the patient needs to feel is pain relief.
So you don't feel Proclaim Plus working. Must feel good to feel good?
In addition to providing pain relief, the signal — because it has these characteristics — also sends signals to other areas in the brain. It's not only relief of their pain. It also activates the pathway that impacts over vigilance to the pain where the person keeps thinking about the chronic pain, ruminating on it. We see relief in these emotional aspects of pain with BurstDR compared to tonic.
How does FlexBurst360 build on that?
All those characteristics of Burst DR stimulation are in FlexBurst360. But now we're able to activate it in the nervous system in multiple locations.
How many locations with BurstDR?
Previously, when a physician would put in a wire called a "lead," most often they use two 8-contact leads which then provide 16 electrical contacts inside the patient’s nervous system. In most of our BurstDR patients, we have only used two of those contacts to deliver the electrical energy to a single targeted location.
And how many now with FlexBurst360?
We can deliver up to six locations of stimulation.
Location, location, location.
So, we're able to focus the burst on those various locations to treat more patients who have multi-site pain.
For example, a patient who not only has low back or leg pain but also has significant pain in their right side of their chest due to trauma there. We can focus stimulation in more than one area.
And they don't feel this work being done throughout their body?
No, because it's programmed below the sensory threshold. They don't feel the stimulation where it's being directed or located. They really don't notice the difference in the programming with the FlexBurst360.
What do they notice?
That they're getting more complete pain relief. We're seeing extremely positive results for FlexBurst360.
Can Proclaim Plus be connected remotely through NeuroSphere Virtual Clinic?
Yes, NeuroSphere does work through Proclaim Plus. Remote programming is able to be accomplished with traditional BurstDR stimulation and also with FlexBurst360 using the Proclaim Plus platform.
What's the energy usage like?
This was a key feature from our early work: How to fractionate the signal so that we could apply it in multiple areas without sacrificing device longevity and without placing too much energy in the nervous system.
Good. How does that "fractionating" work?
Traditionally, we've delivered these little packets of burst energy at 500 hertz. They're delivered 40 times a second, so at 40 hertz. What we've done is neurophysiologic work with people looking at delivering to four places — four locations — we fractionate to 10 hertz.
And what we've seen is that the importance is the burst signal is really in the 500 hertz packets. We can deliver them at different frequencies — down to that 10 hertz example — without sacrificing the therapeutic attributes of a burst signal.
And it's still effective throughout the body?
Yes. We're seeing preservation of the effect of burst even as it spreads across the nervous system in multiple locations.
So, it's like …
A lawn sprinkler. The output of a lawn sprinkler is fixed. But instead of it being in just one location, it's spread over four or six locations.
The waveform itself putting out the same amount of water, but it's "sprinkling" over different areas of the nervous system, providing pain relief in more locations.
For people thirsting for a solution, that sounds great.
I think it's truly special.
Of course. You and your team made it. What's the evidence say?
Meta analysis has been favorable about BurstDR stimulation.
What is meta-analysis?
First, you need to know that Level 1 evidence in medicine is an evidence-based, positive, randomized-controlled trial.
And BurstDR has that?
We've had 20 randomized controlled trials, 5 of which are high enough quality to be included in a meta-analysis.
And so, the meta-analysis says …
This recent meta-analysis — which is a review of all of the highest quality randomized control trials that have been done with a therapy that then synthesizes that evidence — showed that Burst DR is superior to tonic stimulation.
BurstDR is the only waveform in neurostimulation that’s had this kind of meta-analytic rating, which is basically Level 1A evidence rating for Burst DR stimulation, which puts it in a category of one in terms of evidence.
Does Abbott run those meta-analyses?
They're done independently by definition.
Sounds intense.
We are taking a very effective, highly evidence based Burst DR stimulation and making it even better, in more locations. We are the leading waveform in the SCS space, without a doubt.
So, a person in the U.S. looking for this kind of relief today: Can they get it?
Yes. Proclaim Plus has full Food and Drug Administration approval and has been rolled out commercially in the U.S. We’ve been doing implants now for around a month.
Sounds exciting.
We're starting to hear a lot of favorability and excitement. It's going really well in the U.S.
Outside the U.S.?
Not yet available. That will be on a different timetable.
Thanks for your time. The future sounds very promising for people living with pain.
It is. And for people who have stimulators in for a long period of time, who have progression of their pain or new pain develops over time, we also believe that this could be programmed to cover new areas of pain as well depending on the lead location. Multi-site pain relief today and in the future.
IMPORTANT SAFETY INFORMATION
SPINAL CORD STIMULATION (SCS)
PRESCRIPTION AND SAFETY INFORMATION
Read this section to gather important prescription and safety information.
INTENDED USE
This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.
INDICATIONS FOR USE
This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
CONTRAINDICATIONS
This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
MRI SAFETY INFORMATION
Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/MRI-ready.
WARNINGS
The following warnings apply to this neurostimulation system.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.
During implant procedures, if electrosurgery devices must be used, take the following actions:
Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.
Other active implanted devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system.
Interference with other devices. Some of this system’s electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Avoid placing equipment components directly over other electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected.
Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.
Explosive and flammable gases. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The operation of these devices could cause them to ignite, causing severe burns, injury, or death.
Keep the device dry. Programmer and controller devices are not waterproof. Keep them dry to avoid damage. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Device components. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient.
Device modification. Equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service
Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (i.e., jailbroken).
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.
Product materials. Neurostimulation systems have materials that come in contact or may come in contact with tissue. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted.
PRECAUTIONS
The following precautions apply to this neurostimulation system.
General Precautions
Sterilization and Storage
Handling and Implementation
Hospitals and Medical Environments
Home and Occupational Environments
ADVERSE EFFECTS
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:
Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.
The website you have requested also may not be optimized for your specific screen size.
FOLLOW ABBOTT