Stent manufacturers

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Stent manufacturers

Postby CureIous » Sun Dec 13, 2009 5:02 pm

I'm assuming most the people "in the know" , know what's going on, but happened to converse with an out of town cousin of the wife today, who was here for a project management seminar doohicky as I call them. She was (unaware of my situation) talking to a project manager from Abbot about stents and such. I realize that's not worth the paper it's written on, but considering we have a donation to a certain study via manufacturer (and we all know who, where, and why that works), and I don't know if it's the same one, is there anything I could, or should "kick up the line"?

While I realize it's a tad bit on the premature side, I would feel remiss to not toss out the "get ahead of the curve" carrot either.

I got the guys email but am I wasting my time with that or any thoughts on that? I'm totally open and don't want to waste opportunity when it knocks.... Thanks everyone.

Mark.
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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Nothing ventured...

Postby fiddler » Sun Dec 13, 2009 6:43 pm

I can't imagine it would hurt to send out a feeler... and great things sometimes come from these kinds of things.
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Postby SammyJo » Sun Dec 13, 2009 6:54 pm

I'm sure you are already in contact with CNClear about her efforts with the stent makers.

Safety of stents in the jugulars is another hot item. Abbot has already got a study in progress for Absolute Pro stent in other vascular locations, but they should be in on the upcoming CCSVI trials at Stanford, data as well as contributing funding, so they can do long term tracking of patency, migration, slippage etc. At $10k per stent, CCSVI should hold some facination for them.

I was writing about safety last night on this thread,
http://www.thisisms.com/ftopic-8928-135.html
links to the little bit of research I could find, so post here if you have any more.
Questions for you:
1. What is the FDA Product Code for our type of stents, FGE ?
2. Is this the complete list of self-expanding stents: Luminexx, LifeStent FlexStar, Absolute, S.M.A.R.T. Control, LifeStent FlexStar, Protégé EverFlex.

And Big Thank you for going after this, you are in a unique position!
RRMS '95 SPMS '02 | CCSVI 10/09 | Adult stem cells 2012 | http://www.patientsforstemcells.org/
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Postby Johnson » Sun Dec 13, 2009 6:56 pm

Mark, the only things possibly wasted would be a few minutes in e-mailing the guy, or an opportunity if you don't.

You are a pretty eloquent writer, and your posts are always concise (except the cryptic parts... grin), so go for it. Present your case. Nothing ventured, nothing gained, and all that. Offer the 4 or 5 most important links to CCSVI, and invite his contact for any further questions. Be sure to mention that there is a potential demand for a good 5 million stents to start with.

I am reminded of what Jeff said in the W5 piece, about MS being like a water torture, just a steady drip, drip, drip. Every e-mail written, every time it is talked about anywhere, with anyone, is another drip on the wretched calcification of the status quo.
My name is not really Johnson. MSed up since 1993
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10K per stent?

Postby fiddler » Sun Dec 13, 2009 7:09 pm

SammyJo, if it's $10K per stent, how come we can get the whole procedure (including stents) for about half that in Poland?
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Re: 10K per stent?

Postby Johnson » Sun Dec 13, 2009 8:10 pm

fiddler wrote:SammyJo, if it's $10K per stent, how come we can get the whole procedure (including stents) for about half that in Poland?


Market forces...
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Market forces?

Postby fiddler » Sun Dec 13, 2009 8:30 pm

If the stents come from the same manufacturers, then why would sell them to the clinic in Poland for 1/5 or 1/10 of the price. If it's not the same manufacturers, is the quality of the European ones lower... or is it that in Europe they don't worry so much about liability?
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Re: Market forces?

Postby Johnson » Sun Dec 13, 2009 10:36 pm

fiddler wrote:If the stents come from the same manufacturers, then why would sell them to the clinic in Poland for 1/5 or 1/10 of the price. If it's not the same manufacturers, is the quality of the European ones lower... or is it that in Europe they don't worry so much about liability?
...Ted


I picked up from a communication with Dr. Simka (not mine, maybe Phil?) the name of the stent manufacturer used in the procedure. I remember that the brand of stent was in the mainstream. I would not hope that there would be too many knock-offs out there. I get the sense that Dr. Simka and his team are very serious and competent. I think that I understand that you are going in April. Be sure to satisfy yourself of questions. I seem to be booked for May, but I would not necessarily agree to stents without being satisfied at the quality and safety parameters. Heck, my mechanic asks me if I want the after-market parts or the real deal... I have higher standards for my body.
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We need t interest business in stents!!

Postby fogdweller » Sun Dec 13, 2009 11:33 pm

Ironically, I have been working in the industry side of angioplasty and stents for the last 20 years. This is the first time this has intersected my disease. I feel like maybe I can do something to help.

I think the first thing we need to do is really get industry interested in developing stents for venous stenting. No doubt there are special considerations for stenting veins, and convince them that there is market for them. Once we do they will make it a development project and fund the necessary studies to get FDA approval. All the "biggies" will jump on it ...Boston Scientific, Medtronic, Guidant, St. Josephs, J&J; I am probably insulting someo giant company by leaving them off, but point is that we should use whatever we can to encourage involvement by the companies.

I am going to start working on a presentation that I can start using to spark interest. In the meantime, I encourage anyone with any contact such as that mentioned in this topic to use it to see what interest they can spark. i.e. lots of money to be made in stenting veins, especially other than CSVI since that is not yet a proven use for the device and insurance companies may not pay for it.
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Postby Johnson » Sun Dec 13, 2009 11:39 pm

That sounds brilliant, fogdweller.
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Postby CureIous » Mon Dec 14, 2009 12:21 am

SammyJo wrote:I'm sure you are already in contact with CNClear about her efforts with the stent makers.
Negative

Safety of stents in the jugulars is another hot item. Abbot has already got a study in progress for Absolute Pro stent in other vascular locations, but they should be in on the upcoming CCSVI trials at Stanford, data as well as contributing funding, so they can do long term tracking of patency, migration, slippage etc. At $10k per stent, CCSVI should hold some facination for them.
Yeah that's what I wasn't sure about if they were the ones doing Stnfrd already. Didn't want to jump in the pool when it's full already

I was writing about safety last night on this thread,
http://www.thisisms.com/ftopic-8928-135.html
links to the little bit of research I could find, so post here if you have any more.
Questions for you:
1. What is the FDA Product Code for our type of stents, FGE ?
2. Is this the complete list of self-expanding stents: Luminexx, LifeStent FlexStar, Absolute, S.M.A.R.T. Control, LifeStent FlexStar, Protégé EverFlex.

And Big Thank you for going after this, you are in a unique position!


Far as your stent questions I haven't the foggiest notion or even where to find it. Thanks for the response maybe I'll just shoot him an email and see if he can find anything out, heck maybe just ask Dr. D, I doubt he's without stent contacts tho lol. :)

mark
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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Re: We need t interest business in stents!!

Postby CureIous » Mon Dec 14, 2009 12:23 am

fogdweller wrote:Ironically, I have been working in the industry side of angioplasty and stents for the last 20 years. This is the first time this has intersected my disease. I feel like maybe I can do something to help.

I think the first thing we need to do is really get industry interested in developing stents for venous stenting. No doubt there are special considerations for stenting veins, and convince them that there is market for them. Once we do they will make it a development project and fund the necessary studies to get FDA approval. All the "biggies" will jump on it ...Boston Scientific, Medtronic, Guidant, St. Josephs, J&J; I am probably insulting someo giant company by leaving them off, but point is that we should use whatever we can to encourage involvement by the companies.

I am going to start working on a presentation that I can start using to spark interest. In the meantime, I encourage anyone with any contact such as that mentioned in this topic to use it to see what interest they can spark. i.e. lots of money to be made in stenting veins, especially other than CSVI since that is not yet a proven use for the device and insurance companies may not pay for it.


Hey we got people on here that work for UT companies too lol. By the time we're done, we'll pretty much have fingers in all the pies. lol. That and 1.95 will getcha a Starbucks...
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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Re: Market forces?

Postby ScutFarkus » Mon Dec 14, 2009 12:26 am

fiddler wrote:If the stents come from the same manufacturers, then why would sell them to the clinic in Poland for 1/5 or 1/10 of the price. If it's not the same manufacturers, is the quality of the European ones lower... or is it that in Europe they don't worry so much about liability?


I suspect the actual manufacturing cost of the stents is quite small, and the price they charge is intended to recoup their research, development, testing, and marketing investments, which are likely substantial. There are probably additional costs for getting through the legal hurdles in each country to be able to sell them. I get the impression that FDA approval costs a bundle. So the manufacturers probably charge what each market will bear, and just try to be ahead overall. It's similar to the way software companies often have different prices in different countries, and all those prices are a whole lot more than the cost of the CDs it ships on.

So a lower price for the stents in Poland doesn't necessarily mean those stents are different. That said, it seems like something worth checking.

/Scut
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Postby ErikaSlovakia » Mon Dec 14, 2009 1:15 am

Hi, there!
I do not know how important it is, but "name" of my stent is Genesis.
I do not know if Dr. Ludyga always uses the same.
My was 8x29 mm. I do not feel my stent. Even the first night I was sleeping mostly on the left side - my stent is on the left side.
I do not know the cost of this type of stent.
Dr. Ludyga is talking and showing the stent on the video:
http://www.tvs.pl/tv/video,na_wage_zdrowia,5244.html
Well, I am sorry but he speaks polish.
Erika
Aug. 7, 09 Doppler Ultras. in Poland, left Jugul. valve problem, RRMS since 1996, now SPMS,
- Nov.3,09: one stent in the left jug. vein in Katowice, Poland, LDN, never on DMDs
- Jan. 19, 11: control venography in Katowice - negative but I feel worse
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Stents or Angioplasty ?

Postby MarkW » Mon Dec 14, 2009 7:27 am

I observe that North Americans always talk about stents being inserted to treat CCSVI. The European data I have seen indicates that angioplasty is the treatment used most often. Personally I intend to have angioplasty and only consider a stent if the vein closes in the future or will not dilate with angioplasty. Has angioplasty been used in the US ?

My assessment is that angioplasty is lower risk than stenting so it will be easier to find doctors to perform the procedure.
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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