Lynchburg Reporter

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.

Original source can be found here.