FDA approved vein stent

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

FDA approved vein stent

Postby AlmostClever » Sun Aug 22, 2010 4:59 pm

robbed this from CCSVI Locater....

http://ccsvi-ms.ning.com/profiles/blogs ... -manleyfda

Sounds like the stent always applies an outward expansive force to keep it from migrating, i thinks...

Any docs using this yet?
If you can't explain it simply, you don't understand it well enough. - Al Einstein
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Postby AlmostClever » Sun Aug 22, 2010 5:12 pm

more from Boston Scientific on this stent:

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Venous Endoprosthesis is indicated for improving central venous luminal diameter following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract. Unsuccessful angioplasty is defined as residual stenosis ≥ 30& for a vein ≤ 10mm in diameter or ≥ 50& for a vein > 10 mm in diameter, a tear which interrupts the integrity of the intima or lumen, abrupt lesion site occlusion, or refractory spasm. The vessels that can be treated with the Wallstent Venous Endoprosthesis are the innominate and subclavian veins, ranging from 8.0 mm to 15 mm in diameter.

Does this change the rules?
If you can't explain it simply, you don't understand it well enough. - Al Einstein
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Postby garyak » Sun Aug 22, 2010 5:28 pm

This had to come and am glad the timing is what it is.
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Postby AlmostClever » Sun Aug 22, 2010 5:49 pm

awesome video of expanding stent...really cool!

http://www.youtube.com/watch?v=D8bx99ZA-eU
If you can't explain it simply, you don't understand it well enough. - Al Einstein
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Postby AlmostClever » Sun Aug 22, 2010 7:35 pm

So I've been in touch with an IR doing the procedure and asked him about this.

He said they are very familiar with these stents and that there are even newer stebts with even greater radial pressure.

However, they are not indicated for the jugular veins so their use is "off label" like all other stents used in the IJV.

He also reminded me that stent placement is rare anyways.

On a Sunday night, too! These guys are awesome!!!

A/C
If you can't explain it simply, you don't understand it well enough. - Al Einstein
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Postby frodo » Mon Aug 23, 2010 12:36 am

Has anybody contacted the company Stentys? Do they know about CCSVI?
They could be a powerful allied.
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Postby slappy » Mon Aug 23, 2010 8:59 pm

Hi, I mentioned in a different forum, that industry needs to be partnered with to develop the products. The physicians can only do so much with the tools they have. Then industry needs to lobby CMS, a division of the Federal Government, to approve reimbursement for this product. Once a DRG code gets assigned to this procedure, the hospitals will advocate it. Why? Because they can make money.

BSC is a good place to start but they're hurting financially. A start up needs to take the risk and raise VC money to kick start the industry side.
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Postby kirch86 » Mon Aug 23, 2010 9:30 pm

I would imagine that the stent manufacturing company would want to wait and see what comes of ccsvi. They don't want to have a bunch of money wrapped up in development and manufacturing of these stents if the liberation procedure isn't accepted for treatment of ccsvi. Just my 2 cents from a business perspective.
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Postby slappy » Mon Aug 23, 2010 9:41 pm

I completely understand that philosophy from a big company. Which is why you need a start up to take the risk. It's what they do. The big dogs don't cone into these new spaces early.

Stents are not the only solution either.
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Postby marcstck » Mon Aug 23, 2010 10:36 pm

This particular stent has been in use for over 15 years. This recent FDA approval was only for two very specific veins at the subclavian level.

Wallstents are made of stainless steel, meaning that any patient getting them would not be able to undergo MRI studies after implantation, not a good thing for people with CNS problems.

When placed in hemodialysis patients, the patency rate of the stent is pretty miserable, about half of them failing within one year…

http://radiology.rsna.org/content/204/2/343.short
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Postby slappy » Tue Aug 24, 2010 12:54 am

Yes. I agree. More work needs to be done to improve stent patency rates, compatibility and deliverability if to be used in the jugular or azygos veins. I also don't think stents are the only solution. The make up of the stenosis is unknown. I don't believe it is typical atherosclerosis found in arteries. It may be fibrotic in origin. The pathology of the stenosis needs to be understood prior to putting a solution together. Big companies are not going to take this on. Physicians will use existing products off label until a start up takes a crack at this.
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