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Boston Scientific marketing release: DBS Vercise system for PD


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#1 am0665

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Posted 01 October 2012 - 07:24 PM

Hello Dr. Okun,

In the wake of previous cautious development news from Advanced Bionics and Intellect Medical, looks like Boston Scientific has received European approval for patient trials, and a first PD patient has now been implanted with the Vercise system.
http://phx.corporate...9325&highlight=

Would you at the NPF know enough about this capability to comment on it ... beyond the superficial information that resulted so far from St. Jude's Libra and Brio efforts?

More specifically:
- given the vague quote by the Wuerzburg team in Germany on "precisely target stimulation based on patient needs", would you know how much better field shaping is available with this system than with the quadripolar + axi-symmetric Medtronic DBS lead? I note that neurologist Dr. Jens Volkmann is the same one who commented in Lancet on your St. Jude Libra study report
- given previous papers by the Intellect Medical team on measuring parameters of the electrical field directly in the tissue (instead of in the IPG), how much thereof was achieved in this first implementation?
- even if more accurate 3-dimensional field targeting were now available, would you, or an average post-DBS neurologist, know enough about the location of neural tracts in the STN to be able to successfully program a trade-off in primary PD motor symptoms (e.g. freezing, tremor, etc), and at the same time stay away from side effects on speech or vision?

Thank you.

#2 Dr. Okun

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Posted 04 October 2012 - 05:37 AM

Thanks for the question. I will tell you what I know.

More specifically:

- given the vague quote by the Wuerzburg team in Germany on "precisely target stimulation based on patient needs", would you know how much better field shaping is available with this system than with the quadripolar + axi-symmetric Medtronic DBS lead? I note that neurologist Dr. Jens Volkmann is the same one who commented in Lancet on your St. Jude Libra study report

** Volkmann is a very experienced neurologist. The system has twice the number of lead contacts and they can be programmed independently to provide multiple nodes of stimulation. Also, they can reach targets above targets, so you could stimulate in two places for example.

- given previous papers by the Intellect Medical team on measuring parameters of the electrical field directly in the tissue (instead of in the IPG), how much thereof was achieved in this first implementation?

**I am not sure of the answer to above as we need more data to be released.

- even if more accurate 3-dimensional field targeting were now available, would you, or an average post-DBS neurologist, know enough about the location of neural tracts in the STN to be able to successfully program a trade-off in primary PD motor symptoms (e.g. freezing, tremor, etc), and at the same time stay away from side effects on speech or vision?

**It will need to go into trial to answer that question. Another way to look at it is that 90% of patients may not need advanced programming, but having a system like this could theoretically help 10% who get into trouble and they could be referred to more experienced centers for programming.

Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#3 am0665

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Posted 24 December 2013 - 11:48 PM

Hello Dr. Okun,

1. since your last comment on this topic, you may be aware of the clinical trials by the groups of Timmermann and Volkmann in Germany, and of the new clinical trial at by Starr at UCSF and Vitek and U.Minn.  Would you know of something concrete that transpired after the much promoted BS events at the Sydney Mov Dis Conf in June 2013?

2. maybe an even more important issue that a PD DBS neurologist should be able to address:  is there enough known about the neural bundle locations in the STN, that more accurate electric field placement and parameter selection can be correlated to individual positive - negative effects on PD symptoms ... as per the question posed on 1.oct.2012?

Thank you.



#4 Dr. Okun

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Posted 26 December 2013 - 08:02 AM

Yes, our group and many others are now part of a recruiting clinical trial for this new Boston Scientific device.  The hope is that more directed electrical current and more specific programming will maximize benefit and minimize side effects.  More data is needed on this system.


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips


#5 am0665

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Posted 27 December 2013 - 01:37 PM

Yes, one sees recruiting of PD patients for the BS Vercise implants in the US.

But the unanswered issue in the mind of a new candidate could be:

What were the advantage of this device over Medtronic, beyond longer battery life? The marketing promotion talks about 8 field sources with independent programming. My question to you is about its application in a production mode: would a run of the mill programming nurse or neurologist have the knowledge and insurance-covered time to take advantage of the finer axisymmetric distribution (still no circumferential steering). Nowadays I hear of very few programmers even trying multi-polar settings, interleaving, or constant current mode on the Medtronic Activa.

 

An extract from a new article by Prof Marwan Hariz: Deep brain stimulation: new techniques. Parkinsonism and Related Disorders 20S1 (2014) S192–S196:

"... A newly developed DBS device from Boston Scientific, called “Vercise” ... has recently received European CE approval. This rechargeable device allows delivery of a multiple source constant current with possibility to allocate completely different stimulation parameters independently to each of the eight contacts on the same lead. This would result in an electric field that can theoretically be tailored to the stimulated brain structure, by applying various amplitudes, frequencies and pulse widths to different electrode contacts in the target area. Additionally, this device allows stimulation with pulse widths below what is available with the other established brands of DBS in use today, i.e., below 60 ms. Two multicentre trials with the Vercise device are underway in patients with PD: one aims to evaluate if the therapeutic window of the stimulation can be increased by using shorter pulse widths than the classical 60 ms [8,9]; the other trial will investigate if the flexibilities in variation of stimulation parameters at different electrode contacts allowed by this device would improve outcome while decreasing side effects [10].... An important drawback of this system is that the electrodes are not MRI-compatible. Also, as with interleaving, the fact remains that the current delivered will still encompass
the tissue around the whole circumference of the electrode contact, without possibility for true field shaping and true selective directional steering..."



#6 Dr. Okun

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Posted 28 December 2013 - 09:19 AM

You are correct.  As new technology emerges it is not clear that all centers will have the expertise to manage the new features.  Dr. Hariz's article is correct.

 

One frustrating thing for patients will be waiting to see how the device does during trial and whether it gains FDA approval.  Whether these features will be helpful for some patients or not remains unknown, but the thought is that they likely will be.


Michael S. Okun, M.D.
Author of the Amazon Bestseller Parkinson's Treatment: 10 Secrets to a Happier Life
National Medical Director | NPF
UF Center for Movement Disorders & Neurorestoration
Read More about Dr. Okun at: http://movementdisor...hael-s-okun-md/
or Visit Parkinson's Disease treatment and research blogs at:
NPF's What's Hot in Parkinson's disease
or his parkinsonsecrets.com blog for treatment tips





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