Proclaim Plus: The Next Burst in Chronic Pain Care

Pain and Movement|Oct.26, 2022

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.

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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:

Use bipolar electrosurgery only.
Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.
Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.
Set the electrosurgery device to the lowest possible energy setting.
Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

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

Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.
Implantation of two systems. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components.
Implantation of multiple leads. If multiple leads are implanted, leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation.
High stimulation outputs. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. If unpleasant sensations occur, the device should be turned off immediately.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
Lead movement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) six to eight weeks after implantation of a neurostimulation system. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation.
Patient training. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system.
Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient.

Sterilization and Storage

Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.

Handling and Implementation

Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
Handle the device with care. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.
Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.
Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation.
Exposure to body fluids or saline. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation.
System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Hospitals and Medical Environments

High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.
External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable.

Home and Occupational Environments

Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly.
Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)
Mobile phones. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system.

ADVERSE EFFECTS

In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:

Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure
Stimulation in unwanted places (such as radicular stimulation of the chest wall)
Lead migration, causing changes in stimulation or reduced pain relief
Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space
Cerebrospinal fluid (CSF) leakage
Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
Persistent pain at the electrode or IPG site
Seroma (mass or swelling) at the IPG site
Allergic or rejection response to implant materials
Implant migration or skin erosion around the implant
Battery failure

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