PARKINSON'S & DBS: The Ground Realities

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Almost titled it ‘The Grave, Ground Realities’, but as my husband said, some words just shouldn’t be put together……

This is the most important and final addition...probably: it’s for the PATIENT and their families.

That is my hope and my sole raison d'être. I do have an axe to grind, but with no one specific, and I don’t ‘make’ anything from this. (Actually…does a Boston Scientific pen count?? ‘Cos mine’s broke.) In fact, doing this has prevented me from making any money, so I hope that helps in what I said above: It’s for the PATIENT. Why? Because if you don’t know; you can have a voice.

First, let's address all the many, many PD Foundation, Association, Group etc.:


I salute them – all that they do is noble, wonderful and worthy. The peeps that run them are right up there with the angels (but their job is harder...can't just take off when they feel like it). Their fight for YOU is nothing short of pure altruism. Millions volunteer, and they are all both warriors and saints - I applaud every single one of them! But…they have to be, by nature, unbiased. That said, they can 'display what's on offer', but until it's written in stone, they simply can’t afford the ‘luxury’ I have of just blurting out MY opinion. Being me is an advantage in this case. Wow…that’s a nice change!

And, seeing as I’m gonna have to do the loathsome and mention myself, I may as well ‘fes up to my humour and grammar. The afore-mentioned is my ‘steam-release valve’. I always use it when I write. Believe me; I ain’t that funny at home…just ask my husband!  The grammar is deliberate and open rebellion: the Nuns made me take elocution lessons at boarding school – a 10-year old Yank on British soil, geared up in blancmange-coloured, polyester knickerbockers. But they were FUN!....albeit far too alarmed at ‘thrush-outbreaks’, which they put down to violation (from whom, I ask? nearest boys were 15 miles away!), instead of the obvious: polyester…and tonnes of it!  My computer’s’ spelling and grammatical error doohickey only gets used in emailing – not ‘talking’. This infernal machine is the bane of my life. To say we do not get on would be a slight understatement. I have threatened to water-board it, as I can’t find the hammer. 

But getting to the point: it’s just a writing ‘style’ – nothing more. I take the matter at hand with fearful responsibility and gravitas. So, bite me.

To reiterate; I’m a wife and carer for a PD husband. I am also a Peon. For you other-worlders’ outside of the US, a peon is technically the least important person in a corporation – you ‘pee on them’. But I take pride in my lowly status…as a member of LinkedIn, it is gobsmackingly amazing just how many highly-respected ‘Top Dawgs in Neuro-Space’ are talking to me – never met so many CEOs, Neurologists, Neurosurgeons, Neuro-Noggins in my sorry little life. They saw, and have found my posting good. Ain’t trying to toot my own horn – it’s an FYI for YOU. For example: I have no credibility; they have HUGE creds - equals; what I’m saying is verified by them. It’s their collective assurance that has made a few of them (with their unstoppable passion for all things GOOD for the patient), emboldened enough to speak out to me, the peon! Even more impressive (you’ll just have to take my word for this) NONE of them work for Boston Scientific!! To me; that’s pivotal. If I have a hope in hell to reach you, the info’s gotta be pure and untainted.

That said, naturally I will not divulge (even between them) who they are. This paper will comprise more of their words than mine – re-worded, if you follow me….

I digress: Pete (my hubby) was blessed to receive gratis the Boston Scientific’s Vercise with its 25-year battery (IPG), as part of their trialling here in the UK in 2012. The whole thing with PDers coming up to DBS is, there’s neither time nor energy to fully ‘explore’. If you wanna know more about that, see my post ‘The Parkinson’s Paper: DBS? Read this….’

That’s what set me off in the first place. I was intrigued by what was happening at one of the most difficult and exhausting period of our lives. Of course, we’d read up on DBS in Pete’s early PD years; and, probably like you do, we always ‘kept up’ with what’s going on in the wild world of Parkinson’s. But in those quiet hours intermixed with furious activity (PD-related and not), it really hit me – we know nothing. That’s what set a fire under me for the first post. And I thought we knew enough – laughable know! Took me the better part of 18 months to really study this thing. Badgered people endlessly people about it. As I say in the first post; all I got was gathered from the www – no wiki (apologies again, wiki – no offence!). I could (and probably will) be accused of bias. But that is not correct, for what I am displaying here is a righteous predisposition of what I now know to be the realities. You could argue that feelings of gratitude at this ‘gift’’ have gotten the better of me, but you’d be way off base. Unlike most panhandlers in the God-awful days of the Klondike, we really hit pay-dirt…and its solid gold.

I wanted a post like ‘PD & DBS for dummies’…..changed my mind on the last word!

Okay. Let’s get to it – the darker, less savoury bit that YOU need to know.

Verbiage translation (yup, comin’ from me……haha)

HIGHLY RESPECTED TOP DAWGS IN NEURO-SPACE:  NS…..just quicker.

IPG: Implantable Pulse Generator, sometimes referred to as “the CAN”, or simply the battery et al in the device in your chest.

BSC: Boston Scientific.

RC: rechargeable battery.

PC: Primary cell. That’s what you guys who have your IPG replaced every 3 or 4 years; you don’t have an RC.

SCS: Spinal Cord Stimulator for treating chronic pain

DBS: Deep Brain Stimulation

PD: Parkinson’s Disease

VERCISE: is the name of the Deep Brain Stimulation device (and all its components that go in your noggin) that is used, and belongs solely to BSC. One recipient inadvertently referred to it as ‘Versace’. Little did she know how right she was!

INCUMBENTS: the word 'Incumbents' refers to: Neuromodulation MedTech Companies in current competition primarily, but not exclusive of: Lobbyists, Hospital departments offering neuromodulation therapies, hospital purchasing departments, Health-care & Insurance Companies, Big Corporate Business, Pharmaceuticals, Politicking, and The Almighty Dollar. 

Basically, all that makes going to work on Wall Street such fun! ....and so very lucrative.'

Disclaimer: Yadda yadda yadda. Blah blah yadda, blah.Yadda my muddas better than yours,yadda yadda. Blah blah yadda, blah.Ya boo sucks. Yadda nah nah-nah nah boo-boo stick your head in dog poo yadda yadda. Blah blah yadda, blah.Yadda yadda spin on it pal,yadda. Blah blah yadda, blah.Ya boo sucks. Blah yadda. Bite me.

Part 1: Implantable Neurostimulator Batteries:  Are they all equal?

No. Not all implantable batteries – IPGs - whether primary cell non-rechargeable or the rechargeable on the market by all the medtech companies are equal. Far from it! 

Back in the day: ‘For the record, BSC was the first one in the industry to have provided 5 year warranty for its zero-volt technology rechargeable battery in addition to its claims of battery life of up to 25 years. Initially both main neuro incumbents offered a 1 year conditional warranty. Over time they followed BSC with commercial warranties offering also 5 years.’  These days, because of the roots of its Neuro technology coming from unique cochlear technology, BSC is streets ahead of the Incumbents regarding many of its devices, including Vercise for Parkinson’s DBS. Their 25-year rechargeable battery coupled with the patient-friendly recharging – honestly, a monkey could do it – no offence, but if you’ve got a different device, you’ll know what I’m talking about!

I must here reiterate what ‘cochlear’ means. In the Oxford Dictionary, it says: ‘Cochlea: The spiral cavity of the inner ear containing the organ of Corti, which produces nerve impulses in response to sound vibrations.’

A cochlear implant is basically a very sophisticated hearing-aid with a surgically implanted electrode and external components. So a sensory neurostimulation system for the cochlea (something as complex as PD) means ‘minutiae’ as in really, really tiny. And that means they can pack a lot more punch into that puppy. I’ll give you the example from my first paper: ‘Think of the old Christmas-tree lights – remember when if one light went out the whole lot went out? More advanced Technology with its roots from cochlear implant developments means that this perilous business no longer happens. If one ‘light’ goes, the rest reconfigure to pick up the slack.’

Knowing now what I at know, it’s one helluva lot more than that, but I could wax lyrical on that for days!

I ripped this straight off someone’s site:

The Vercise™ DBS system was designed to help make a difference to both physicians and patients. The intended benefits include:

·         Patient Comfort: The Vercise implantable pulse generator has been designed to have a small footprint of 20 cm²

·         Longevity: The Vercise™ DBS System uses rechargeable battery technology. The stimulator battery is indicated* to provide at least 25 years of service

·         Patient Convenience: The Vercise™ charger and remote control are completely cordless and designed to make charging simple.  The remote control communicates with the stimulator from a distance of 45 cm or less, allowing the patient to view the screen while communicating with the stimulator

·         Reliability: It is intended to reduce surgical interventions via the Vercise™ DBS System's Zero-Volt™ battery technology. This means that the battery can be completely discharged without causing battery failure or damage – even when the patient forgets to recharge.

Both devices are completely cordless and designed to make charging and using the device easy.

The remote control allows the patient to control their stimulation (ON/OFF) and assess the stimulator battery status. The remote control communicates with the stimulator from a distance of 45 cm or less. This enables the patient to view the screen while communicating with the stimulator.

 The charger contains one simple-to-use on/off button. Once the charger is turned on it will begin to beep until it is aligned with the stimulator. The charger can be worn with an adhesive patch or a charging collar. The charging collar is lightweight, adjustable, and available in two sizes.

For any information related to Vercise™ DBS System and its availability please contact:

Vercise.DBS@bsci.com

The Vercise™ Deep Brain Stimulation System is designed to provide comfort, control, and convenience to the clinician’s practice and to patients with Parkinson’s disease.  It is intended to minimize side effects of stimulation by controlling current at each individual contact on the lead (essential capability that enables greater stimulation precision via current steering hence providing greater individualisation of therapy).

The system is designed to offer unique patient benefits including the longest battery life available for DBS therapy and the smallest stimulator footprint*.

* Comparisons based upon data from St Jude Medical Brio Manual, Medtronic Activa RC Manual, Vercise DBS System Manual

·         Video from Spain [3:32 min]: A Patient Testimonial with Vercise™ Deep Brain Stimulation experience

·         Video from the UK [4:57 min]: Life before and after DBS

·         Video from the UK [3:48 min]: Vercise Experience (Implant, Remote Control and Recharging)

The middle one’s ME!! Okay, it all about Pete……….

Okay, if you wanna read the whole thing, here’s the link:

http://www.epda.eu.com/en/parkinsons/medinfo/neurosurgery/vercise-dbs/    

Not even from their own website. Why? Because I don’t want them involved. It is of pivotal importance to me that they have NO SAY in what I write. I’m real careful to keep them outta it – the culpability has to stay solely in my court.

I leave the end of Part 1 to the NS to explain a bit of ‘how we got here’:

‘Cochlear implants were indeed a very challenging development as this was the first "sensory neurostimulation" indication requiring very miniaturized electrodes and customized precise programming capabilities based on neuromodulation principles.

So, it was not so easy for the [Incumbant] companies leading in the cardiac-pacing world to simply take their pacemaker technology and with some tweaking use them also as cochlear implants. However some succeeded in modifying sufficiently to bring spinal cord stimulators and DBS systems to the market, opening the field of neuromodulation to treat chronic pain and movement disorders like PD and Dystonia’

Part 2: The Implantable Battery Competition

Let’s start with a bang, shall we?

 ‘BSC’s decision to enter the new space called neuromodulation by acquiring Advanced Bionics who were just commercializing their cochlear implants at the time, took a couple of years of market and technology assessment including many discussions with neurosurgeons, pain specialists, neurologists, and even hospital purchasing departments, to try to understand what was high on their unmet needs at the time with what they were using (only two [Incumbant] providers’ neurostimulators were on the market at that time). Their (BSC) research revealed their (neurosurgeons, pain specialists, neurologists) needs after years of experience: These were: electrodes that don’t break, precision of stimulation zone, the longevity of the batteries, and the user- friendliness of the externals like the patient remote, and of course the programmers used by the health care professionals to program the stimulators.‘

I think you don’t need me in this…the NS got it!

‘Please do not forget the Docs [Doctors] in this paradigm shift!!!  Everybody points out that companies are happy to sell new devices every 5 years, BUT the Docs also love to implant new devices every few years…. Perhaps something to do with how much revenue and work will they miss if that were to go away…???  The prices for devices offered by the companies are not really segmented by longevity and are in the same general ballpark price range, regardless if they last 5 years or much longer…  Certainly, calculated on a cost per annual basis, the much longer lasting devices are MUCH cheaper than the 5 year devices!  We really need the PATIENTS here to insist on the best device and the highest longevity, nobody else will speak out for your interest for the longest lasting devices!

‘I wonder how long it would have taken the two main incumbents to bother to start offering rechargeable systems since everyone was (and many still are) happy implanting non-rechargeable systems where pain patients (for example), were often asked to not use all the ‘time’ in their implanted device, in an attempt to prolong the battery; thus compromising pain therapy to prolong the life of the implanted non-rechargeable battery, and then simply replacing every couple of years. I discussed with some neurosurgeons the ‘wisdom’ of using the DBS stimulator IPG that was being regularly replaced: - in worst case examples every 6 to 9 months for Dystonia patients with DBS implants because of the high energy consumption and exposing the patient to repeated surgery risks [over, that is the 25-year battery life offered by the Vercise device from BSC].  But everyone thinks short term and for their status quo, it’s a great recurrent billing and revenue for companies to be pushing only non-rechargeable devices that require replacements.’

‘All this knowledge and interactions with the chronic pain patients implanted with the rechargeable SCS systems was of course also incorporated into the Vercise DBS system too. And in my opinion it never ends as continuing improvements are always there if people listen and incorporate the real world experiences back into those improvements.’

Part 3: Patient-First Policy at BSC

This is the most important thing now: for you to SEE what I see! The patient comes first.

One Neuro-Spaceman told me of a 'high-up on the ground' saying: 'At the beginning, the salesman in me was impatient at why it takes so long to bring these new neuro products to market, but understanding in more detail the philosophy and practice of designing and testing the neuromodulation devices that fit the patient needs and not the other way round, provided the balance with stronger belief over time that I would not be bullshitting or selling a dodgy claims. I'd truly be able to look into the eyes of the doctors and the patients and KNOW that my integrity was intact convincing them of that better was possible with the new technology being introduced in the market. Each employee working in the plant was made to understand that they are working on a system that has to be implanted in a patient providing therapy for this long period... imagine it was member of your family, would you want them to go through unnecessary battery replacements now that this smaller and longer lasting rechargeable system was available? 

This is pivotal to getting across the true, unsullied passion of BSC people. I can't even begin to imagine what went through their collective head!

Another Neuro Spaceman said: ‘...in my opinion the issue in the near term has less to do with the pharma lobby (although they have more to do with the delay in patients getting even to the option of neurostimulators, instead of popping pills so their interest is to maintain their maximum budgets there). The main issue in terms of adoption of rechargeable neurostimulators has been to do with two main forces. The two main incumbent companies’ pressures (even if they have both now non-rechargeable and rechargeable batteries -the former being the biggest part of the business, and the latter (in my opinion) being technologically inferior to BSC 25 year battery technology. They have played to delay faster conversion of markets to rechargeable neurostimulator batteries for chronic therapies. It’s the conservative short term thinking healthcare system that only looks one or two years ahead in terms of hospital budgets. The rechargeables are considered to be more expensive up front than non-rechargeable batteries so, when the crazy alliance eventually realized that we were pushing the “inconvenient and painful truth” directly to the patients and patient associations about advantages of rechargeable technology, they [the incumbents], made their whole strategy to position rechargeable as a ‘second tier option’ and they even lobbied  the health systems and guidelines - even to extent of saying that, by default, ‘all patients should get first the cheaper and shorter life non-rechargeable, and only if they come back with empty battery they could be candidate to be implanted with a second surgical operation with rechargeable battery’.

Furthermore (really made my day!), I was told;

‘Finally, YES, you recognized a key element of the design requirements - to always put the PATIENT in the centre of the therapy, and the Doc [Doctors] second in line!

This however, is generally not picked-up enough by the patients….

Part 4: The Painful Truth: the Incumbents

‘forces against meaningful innovation and change are hard to overcome!’

Word (in Neuro-space) has it that BSC might be forced to provide (in the future) shorter life IPG batteries, instead of its life-changing 25-year one for example for neurostimulators. Why? Because of the Incumbents’ practices and tactics to delay the conversion – all of them!

‘As for the issue of challenge of adoption of rechargeable battery and valuing fairly the rechargeable long life batteries, we became the ‘broken record’ in the neuromodulation space, arguing to get a balanced and complete picture of the cost vs total value of this innovative technology, to look hard at the total value - clinical, economical and quality of life for the patients over the years of use; fighting the crazy mentality and continuing reality of implanting non-rechargeable.....even if intellectually majority of stakeholders accepted the superior advantages of smaller and rechargeable IPG systems – particularly for the patients.

Boston was the first one to bring the rechargeable neurostimulators to the market and challenged this status quo and quasi mono/duo-polistic market reality at the time with hardly any meaningful innovations and scarce healthcare resources being used up; with up to 30 to 35% of procedures for SCS and DBS being battery replacements (some hospitals even projected they would only be able to do battery replacements only over time and no new patients but continue to implant non-rechargeable batteries – almost like an addict!), one of the consequences was of many new qualifying patients getting delayed or not getting implanted because of limited budgets used up for battery replacements first.

Sad reality and dogmas in established health systems which consider new technology to be more expensive rather than retiring or decommissioning older and now inferior technologies, or perhaps more the vested interests in the established healthcare systems in US and particularly in Europe that make it so hard to bring and adopt new meaningful innovation faster.’

So indeed...at least within neuromodulation space, fighting the battle with rechargeable 25 year battery life systems against the incumbent forces, who have both cheaper non-rechargeable and rechargeable solutions and, keeping in mind particularly, the non-US and non-European markets with emerging healthcare systems and even more limited healthcare budgets puts BSC Neuro in more challenging position. The global market demands are the reason for offering cheaper solutions. However this decision to have ‘cheaper’ non-rechargeable systems still does not justify the forces blocking or delaying the greater adoption of the 25 year battery life systems in the developed US and European healthcare systems for treating chronic illnesses requiring chronic long lasting therapy without requiring unnecessary battery replacements. Believe me, in the scheme of things, these ‘forces’ simply aren’t interested in the patient first. So BSC will likely introduce the shorter battery life systems but hopefully, in addition to, rather than instead of, the 25 year systems like Vercise.’ Interesting to compare similar battles in the the world of cardiac pacemakers and defibrillators.

‘Let me give you an example, the BSC defibrillators and Heart Failure Devices are among the smallest (and thinnest) implantable devices in the world, AND they generally provide for a 10+ year lifetime (Best primary battery and very low power consuming electronics, which did cost Millions to develop and in fact, BSC makes its own primary batteries in a BSC battery plant in _). Again, putting the patient in the centre of the therapy provided! The competition provides these device with a longevity of about 5 years.’

He went on to say: 'The competition provides these devices with a longevity of about 5 years. You would think that this would give BSC a real boost in market share, but NO, this did not happen. Instead, BSC is now developing the same devices with battery- longevity of 5 years with a smaller battery in a smaller can, hoping that the smaller size will provide for the market share improvement…. Is this the best for the patient? I don’t think so…’

‘…  BSC, as far as I know, will keep the very long lasting DBS implantable neuro-stimulators!!  I just gave this as an example of how important it is for the PATIENTS to speak up and to demand long lasting devices, otherwise the good companies will be forced to change their offerings, if not rewarded for doing the right thing!  That is now happening in the Defibrillator/HF implantable device world, not (yet!) in the DBS neuro-stimulation world…. But everything is market driven and if BSC will not see an advantage in providing very long lasting DBS devices, why would they continue to offer them?  Maybe instead offer something else for the money invested in the cost price of the device, that will resonate more with the Docs??’

This is outrageous, totally unacceptable, and just plain WRONG! It will negate the whole point and proven promise of DBS Vercise' 25-year battery. We all lose if the Incumbents get their way.

Should BSC be 'forced' to include a shorter life non-rechargeable battery, when the 25-year battery is so clearly best for the patient requiring chronic therapy instead of having to undergo unnecessary battery replacement surgery? If so, it's the fault of the health system and the vested interests: short term profitability, Politics, Pharmaceuticals and Incumbants Lobbying. The Almighty Dollar demands. And if BSC don't agree to this ‘future demand’, will it impact their FDA approval? Looks like it's as simple as that!

This is where the rub lies: if we - the patients and families - don't speak out NOW, we have lost any chance in a 'voice'. And we might lose BSC's 25-year battery - that piece of art in motion, which they are constantly finessing, as they do in all things.

So I ask for your voice, for your passion, for your commitment. Speak now, or say goodbye to love!'