Addressing patient variability and the dynamic nature of pain: The value of customised therapy

September 2018

E D U C AT I O N A L S U P P L E M E N T

Addressing patient variability and the dynamic nature of pain: The value of customised therapy

This educational supplement has been sponsored by Boston Scientific

neuronewsinternational.com

Addressing patient variability and the dynamic nature of pain

In this supplement:

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Inside Boston Scientific Three questions for Vincent Sourdaine

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Coverage made easy Optimised and customised therapy with the Infinion CX

Innovation starts here...

With a series of new products this year and the acquisition of Cosman Medical’s radiofrequency portfolio, Boston Scientific continues to drive forward as a leading provider of meaningful innovation for patients suffering from chronic pain. With over 200,000 patients implanted globablly, patient centric solutions and physician partnerships are integral to the company's continued growth and innovation.

This educational supplement provides a look at the pace of innovation from Boston Scientific Neuromodulation—from the latest products and clinical data to insights from key physicians from across Europe.

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Multiple waveform technology Where are we today?

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A history of firsts The evolution of SCS

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Offering patients and physicians more options to treat chronic pain

IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case. Decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand. Boston Scientific (BSC) does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. 2018 Copyright © Boston Scientific Corporation or its affiliates. All rights reserved.

All rights reserved. Published by BIBA Publishing, London T:+44 (0)207736 8788, publishing@bibamedical.com. The opinions expressed in this supplement are solely those of Boston Scientific and the physicians and may not reflect the views of NeuroNews.

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Three questions for Vincent Sourdaine, Director, Neuromodulation EMEA at Boston Scientific Why did you choose to work in neuromodulation?

Working in neuromodulation is more than a job to me, I have found a real sense of purpose from being in this industry for over 20 years. I am proud of the meaningful innovations we have introduced over the last 13 years to neuromodulation—devices that can transform patients’ lives and the lives of their families.

It is an exciting time to be in neuromodulation, and innovation has moved quickly since the launch of our first SCS system in 2005. When I look at the excitement Neuromodulation is triggering and the incredible pace of innovation we have demonstrated so far, I feel at times like we move with the agility of a small start-up within a well established medical devices company.

Innovation does not come from staying within our comfort zone, it is about taking risks and pushing boundaries. Moreover, collaborating and learning from our trusted physicians and challenging the status quo together provides us with the feedback that allows us to drive innovation forward in the right direction. I very much enjoy being part of this evolving journey in neuromodulation.

NM-563809-AA

Boston Scientific recently acquired Cosman Medical—why do you believe radiofrequency is the right fit for your portfolio?

We still face many challenges within this industry. Awareness around the different therapies available to treat chronic pain remains low and the patient pathway can be very long and tedious, often ending with frustrated patients unable to find the right pain relief for them.

The addition of radiofrequency ablation was a natural extension of our current product portfolio and will help us to provide physicians and patients with more options to address chronic pain across the care continuum with non-opioid therapies.

Cosman Medical has been dedicated to pushing boundaries within radiofrequency since 1952 with a broad range of highquality products. Their dedication to innovation was a perfect fit with us and we are excited to expand our capability to provide innovative solutions to our physicians and patients with spinal cord stimulation (SCS) and radiofrequncy (RF).

Vincent Sourdaine

Addressing patient variability and the dynamic nature of pain

The field of pain management is evolving with new technologies and advancements in both SCS and RF. We are excited to be at the forefront by delivering meaningful innovation that improves patient lives.

What is the future for chronic pain management?

Much has changed over the past few years and the focus has been on different waveforms and their mechanism of action and long-term outcomes. So where do we go from here?

The truth is that every chronic pain patient is unique and pain patterns change over time—patients can benefit from a flexible device that responds to their evolving conditions today and in the future. So our focus and commitment going forward is to continue to invest in clinical research to address this need and in particular, looking at the different ways in which waveforms can be utilised through combination therapy.

We are committed to deliver meaningful innovation and exploring new ways to treat chronic pain patients.

It is an exciting time to be in neuromodulation and innovation has moved quickly...Innovation does not come from staying within our comfort zone, it is about taking risks and pushing boundaries.

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Addressing patient variability and the dynamic nature of pain

Coverage made easy: Optimised and customised therapy with the Infinion CXTM Being able to treat multiple targets with one lead though a single insertion needle allows physicians to treat pain effectively with minimal intervention. Speaking to NeuroNews, Dr Jose Paz (Hospital Universitario La Paz, Madrid, Spain) explains how using the Infinion™ CX 16 lead, alongside the ENTRADA™ needle gives him the flexibility and accuracy he needs to treat his patients effectively.

What are your results with Infinion CX? To date, we have implanted 19 patients (38 leads) with the new Infinion CX lead.

The patients implanted have, on average, a sustained pain relief of above 70%.

Furthermore, the trial-toperm rate has been 100% in the patients trialed to date. All patients got an implantable pulse generator (IPG) implanted after the trial, this was probably due the multiple programming options that this system offers.

What is your experience of handling the Infinion CX and the ENTRADA needle?

The capacity to cover three vertebral levels. Most of the leads are implanted between the levels T8–T10, which makes the programming options superior. The lead is able to cover a range from standard (tonic) stimulation— which I think we should still believe in—up to advanced sub-perception programming options, in an anatomical location.

The insertion with the ENTRADA needle is easy and, in my cases, I have found it to be safe: in all of my experiences with this needle I have had no dural

Dr Jose Paz, Hospital Universitario La Paz, Spain

punctures. For both the insertion, and the epidural space entrance, I have found that there have been no more major difficulties than with the normal Tuohy needle.

Furthermore, when peeling away the sheath, the lead does not move from the original position, meaning that relocation is not needed.

Regarding the navigation with the Infinion CX lead, I consider it as very good. In all cases I got the desired location (superior part of T8), with two leads in parallel to the midline and with a separation of 2–3mm between the leads.

Infinion CX lead NM-563803-AA

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What is the main benefit of having 16 contacts in one lead for physicians?

In my opinion, the major benefit is the flexibility you gain when you have the possibility of covering three vertebral levels.

With this coverage, the programming can be customised to the patients’ needs and can also be adapted to the patient as the pathology advances.

I am convinced of the benefits of this lead when I see the results in my patients, and I almost always use it in patients with complex lumbar pain.

Even when the initial limb pain is unilateral, many develop bilateral pain in the future.

What are your thoughts on capturing multiple pain areas, such as back and leg, with only one lead?

This is one of the best benefits of the new lead.

The capacity of covering such long distances while maintaining the precision of tightly-spaced contacts, allow us to work with different pain areas in an independent way, making it possible to stimulate the lumbar area with the upper part of the electrode and legs or feet with the lower part. These areas can also be adjusted by the patient independently.

In my experience, I always use two electrodes to guarantee good paraesthesia stimulation as well as having options for sub-perception stimulation anatomicallyguided.

However, in my opinion, a single lead could perfectly cover a high percentage of the pain area (some time ago I used to implant only one lead in midline).

According to current literature, lead migration happens in 15% of the cases. Do you think the 67mm span of Infinion CX will allow you to recapture the pain area if the lead migrates?

Yes, although the lead migration in my patients is infrequent, when it does occur it is usually no more than three or four contacts, so if the pain area is covered with a tight-space 16 contact lead, it is sure that the stimulation zone can be recaptured without the need of lead relocation.

Has the introduction of Infinion CX shortened the on-table testing time for you (or made it redundant)?

In 90% of the cases I didn’t need to move the lead from their initial position after the on-table testing. The debate as to whether this testing is necessary or not is not trivial. In my experience, with this new electrode, the time needed for on-table testing is no longer than five minutes and it gives us the guarantee of having the pain area covered.

Has the use of Infinion CX changed your practice?

I have changed my practice a little bit, especially when inserting the needle. With the conventional needle, I first insert it to find epidural space and then I open the incision. With this new needle, the anchor is pre-loaded, so I need to open the incision before inserting the needles because I use a bilateral approach.

This minor change had no impact in my patients since conversion percentage in the trial to permanent implant is practically 100%.

Lumina study – Veizi et al., Pain Medicine 2017:

· Long-term outcomes of SCS using 3D Neural Targeting algorithm · Multicenter, open-label observational study

24-month LUMINA data results show highly significant pain relief in 213 patients with the Spectra and the Illumina 3D targeting algorithm in comparison to older generation SCS systems.

Multiwave study – Berg et al., Expert Review of Medical Devices, 2017: 7.17

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Pain Score < 3 2.96

2.94

Baseline 1 Year 2 Years All Patients

PROCO RCT study – Thomson et al., Presented at NANS 2017:

Pulse Width

e litud Amp

Study showed no clinical difference in pain relief using frequencies from 1 kHz to 10 kHz but with correct neural dosing 1 kHz provides excellent pain relief using significantly less energy than higher frequencies.

Neural Dosing

ncy

controlled trial with crossover

60% (N=250) of patients used advanced waveforms and field shapes, either exclusively or in combination with standard rate SCS to achieve optimum pain relief highlighting the value of multiple waveform options.

Used Standard Rate Only 40%

60% Used Advanced Waveforms

WHISPER RCT study – North et al., Presented at NANS 2018:

ue Freq

· Impact of kHz frequency on SCS clinical outcomes. · Multicenter, double-blind randomised

· Real world utilization of multiple waveforms and field shapes · Multicenter, open-label observational study

· Use of multiple waveforms in long-term implanted patients with ·

Addressing patient variability and the dynamic nature of pain

In recent years a large amount of clinical research has been dedicated towards developing our understanding of different waveforms and their applications to improve long-term pain relief.

monotherapy SCS – Evaluating the use of subperception SCS at <1.2 kHz A prospective, multicenter, cross-over, randomized, and controlled study

Patients who are given the choice to use both sub-perception and paraesthesia based spinal cord stimulation (SCS) therapy achieve superior outcomes in comparison to patients who have only one SCS therapeutic option.

MultiWave conversion study – Haider et al., Neuromodulation 2018:

· Spinal Cord Stimulation (SCS) trial outcomes after conversion to a multiple waveform SCS system · A multicenter, open-label, real-world, observational study

50 % of trial failures (N=14) at 10 kHz were converted to >50 % pain relief when trying different waveforms suggesting that providing multiple waveforms during trials may overcome limitations of a single waveform for optimum pain relief. Thus, chronic pain’s variable nature across patients and over time lends itself to multiple waveform therapy.

50%

of trial failures

50% pain relief

This latest set of data shows us that customization and correct neural targeting are vital for long-term pain management. Different patients and pain types may respond differently to these waveforms and patients may need various waveforms throughout their lifetime to optimise their pain relief. While monotherapy may lead to tolerance over time, multiple waveform options in one device may help to sustain efficacy over a longer term.

In addition, neural targeting improves long-term pain coverage and with the correct neural dosing, sub-perception stimulation can provide pain relief and effective energy consumption of the SCS system.

What is clear from the body of evidence available today is that customized therapy with multiple waveforms is essential for providing sustained efficacy for each individual patient, today and in the future.

Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.

NM-563810-AA 2018 Copyright © Boston Scientific Corporation or its affiliates. All rights reserved.

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Addressing patient variability and the dynamic nature of pain

Illumina 3D programming system

Smaller. Thinner. Contoured Design.

The first system to account for the 3D environment of the lead in the spine for optimal stimulation and pain relief.

Precision NoviTM, our first primary cell, non-rechargeable IPG, with MICC and Illumina 3D capacity, is launched

Coverage, Flexibility and Advanced control

24-month LUMINA data results are released

Precision Spectra™ SCS System is launched to provide pain relief to a broader spectrum of patients. The first 32 contact, Illumina 3D platform

LUMINA is the first SCS study to show highly significant pain relief in 213 patients and excellent outcomes in long term pain relief for axial back pain only patients

2012

Coverage made easy with a 16 contact lead for seamless coverage over three vertebral levels through a single insertion needle.

Spectra Wavewriter™ – Multiple Therapies Combined waveforms for personalised therapy. The only SCS system offering proprietary combination therapy, waveform automation and unique sub-perception algorithms.

2018

2015

2005 Precision control in SCS

Infinion CX – The first and only 16-contact percutaneous lead

2019

2016 More options in one device

Acquisition of Cosman Medical

The Precision Plus™ Spinal Cord Stimulator System, the first rechargeable platform with unique current steering technology (MICC), is available to patients.

MultiWave™ Technology offers the flexibility of multiple waveforms, within a single device, for a customized SCS therapy.

Radiofrequency ablation is integrated into the Boston Scientific pain portfolio providing more therapy options to pain patients.

Wireless Patient accessories

More than just MRI

PVD labelling

The first wireless remote control and charger for ease of use and patient comfort.

Precision Montage™ receives CE Mark offering safe access to full-body MRI combined with Illumina 3D programming and Multiwave Technology.

Treatment of neuropathic pain patients associated to peripheral neuropathy is discussed with Boston Scientific IPGs.

Multilumen lead design For an easily steerable lead and reduced lead fracture.

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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France.

NM-563810-AA 2018 Copyright © Boston Scientific Corporation or its affiliates. All rights reserved.

Since acquiring Cosman Medical in August 2016, Boston Scientific has become one of the only medical device companies to offer multiple therapy options across the pain care continuum with both spinal cord stimulation and radiofrequency ablation.

Radiofrequency ablation has more than a 50-year track record of reducing or eliminating pain in patients with chronic pain. During the procedure, heat generated by radiofrequency is applied to targeted nerves that are causing pain.

This heat creates a lesion and disables the nerve's ability to continue to transmit pain signals, reducing or eliminating pain.

Many patients who undergo a radiofrequency ablation procedure can experience pain relief for six to 12 months. The therapy is inexpensive compared to many other chronic pain treatment options such as surgery or opioids.

Dr Jan-Willem Kallewaard (Rijnstate Ziekenhuis, Arnhem, the Netherlands) spoke to NeuroNews about the application of radiofrequency ablation and its use in the treatment of chronic pain.

Addressing patient variability and the dynamic nature of pain

Offering patients and physicians more options to treat chronic pain

Dr Jan-Willem Kallewaard Rijnstate Ziekenhuis, the Netherlands

What is the key to successful radiofrequency ablation for chronic pain patients?

The key to the successful use of radiofrequency ablation is good patient selection and good technique. When we select the right patients for the right treatment and treat them according to the guidelines, radiofrequency ablation therapy has a bright future. However, when and if, we continue treating and selecting the wrong patients, radiofrequency ablation could become obsolete.

I have found that patients with mechanical low back and neck pain (facet and sacroiliac joints) and knee pain often respond best to radiofrequency ablation.

Are there lesser known applications of radiofrequency ablation that have shown positive outcomes for your patients?

I have seen positive outcomes using radiofrequency ablation on the genicular nerves for the treatment of chronic knee pain.

Pulsed radiofrequency is also a good option for treating dorsal root ganglions (in chronic radicular pain).

In addition, trigeminal radiofrequency is a very

good option for the treatment of trigeminal neuralgia in patients over the age of 60 years.

The Cosman G4 generator allows me to carry out all these types of procedures.

In my experience, this generator brings easy handling, a clear and easy-to-read screen, the ability to treat four lesions at a time; multiple options with standard radiofrequency, pulsed radiofrequency, dual lesion etc. It also provides plenty of power.

How does a physician go about prescribing radiofrequency ablation? Is radiofrequency ablation a stepping stone to a more longterm treatment, such as spinal cord stimulation?

Radiofrequency ablation would

Cosman G4 radiofrequency generator

typically be prescribed earlier in the chronic pain treatment pathway.

Sometimes a patient that responds well to radiofrequency ablation will also respond well to spinal cord stimulation but this depends on the nature of their pain. In patients with neuropathic pain it is possible that, if they receive pain relief from radiofrequency ablation, they may also benefit from spinal cord stimulation.

Where do you see the future of radiofrequency ablation for the treatment of chronic pain leading?

When we use the right indication and technique, there is a bright future for radiofrequency ablation with very positive outcomes for patients.

It may be possible for radiofrequency ablation to be used more commonly and widely to treat chronic pain, but only when we are able to increase the amount of evidence available for these newer applications. That is why working together in this field is mandatory; we must partner with companies, such as Boston Scientific, to improve the evidence and further expand the therapy. Having one company offer multiple therapy options across the care continuum can help bring therapies like radiofrequency ablation and spinal cord stimulation to more physicians and more patients.

We must build and learn together to help other pain physicians across the world to adapt the algorithm and technique.

NM-563802-AA

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