New Flow Diverting Stint?

Does anyone have any information regarding a "Flow Diverting Stint"? I understand that this has not been approved by the FDA, but there are trials going on in the US. My doctor thinks this may be the best thing for my dissecting aneurysm, which involves the entire artery. The only other option is bypass surgery, and he thinks I run a 20% chance of stroke, or potential cutting off blood flow to part of the brain.



Hello from Everett…if I remembered your city/state correctly…I am new to this site; not to aneurysm(s) and stents. Try the 'net search of “flow-diverting stent” that will bring up data; one which may relate to your interest is ISIS Project 3966; I just glanced quickly and did not check details or FDA site. That data can be exhausting… there are now 3 (known by me) stents for cerebral arteries of FDA approval. Learning how to access it was exhausting in itself to me. Recently, I have been interested in sharing results w/others who have cerebral stent implants. If anyone wants the FDA product approval numbers of those 3, let me know.

I have had a stent for approx. 2 years. It is checked once a year and am told all if fine. If it was me, I would opt for the stent even though it isn’t recognized by the FDA. After all we are survivors and I feel we are here to help others now and in the future. Maybe testing these things on us will help someone else down the road. Hope all goes well with you.

Carol, thank you for your input.
Was your stent implanted when your coiling was done, or related to an angioplasty, or under the study of the Flow-Diverting that Chris asked about?
My reason/ interest in securing info on stents relates to those behind me/us. There is so much data that can be available to our peers sooner than much of it is. In time, I will reasearch more on the Flow-Diverting.
Thanks for your input.

My stent is the Neuroform and Enterprise microdelivery stent used to help with the coiling. It was inserted through the femural artery. As the stent was released, it opened up until it fit the inner wall of the blood vessel thus forming a bridge across the neck of the aneurysm. Coils were placed into the aneurysm sac. Blood continues to flow normally in the artery, but is directed away from the aneurysm. See, I really don’t know which one it is so I am just giving you the info I have. It’s very good hearing from you. I have so many questions that I feel others in my position may have the answers to. Later…

There’s so much for us all to learn/share; I attempt to provide resources for each to read, interpret, ask their mds. The Neuroform2 was FDA approved for use with a wideneck aneurysm to help hold the coil implants from retracting into the parent artery. The Neuroform3 is some version; as I understand, it remains under the same FDA approval number H020002. Put that # in ‘search’ for the sites w/info; the FDA site will bring you to its HUD/HDE data (Humanitarian Use Device and Humanitarian Device Exemption) that relates to approval of annual low volume use devices. It was a tremendous challenge for me to find/learn. If you go to the FDA site with the #, it will show a different manufacturer’s name which is a subsidiary of the marketing parent company. Did you receive the patient information booklet and card-to-carry? None of us have all the answers, we may have much the same, and diff experiences from location, size, ruptured/unruptured, and much more. I hope providing resource data will help others, like this little bit of FDA data. If I have a typo or interpreted wrong, you’ll be able to find out from the FDA site, asking your md, etc.

Pat: thanks for replying and hello from Renton!!! We’re almost neighbors! I too am new to this site as a friend of mine made a donation in my name. My aneurysm burst 3 years ago and have just been trying to “get back to normal”. I started getting “headaches” in June so back to the doctor I went. This is when I learned of the Flow Diverting Stent. I’m not too keen on having brain surgery and would prefer to postpone until after I retire (maybe 7 years down the road) so when my md told me about this stent I was really excited. I’ll try searching again to see if I can get more info. Do you have to have angiograms or MRIs? Have angios made you sick? Whenever I have an angio I get sick for at least 8 hours…one way to loose weight I guess and they can’t seem to help me with it.

So can doctors use a stent that is not approved by the FDA? My doctor said they are using it in Europe and South Africa…hmmmmm, maybe a trip to Europe!!

Yes, we are almost neighbors; we have a local support group that meets the last Wednesday (tonight) of 10 months; the other two adjusted for holidays. I go to few, bsed on weather, traffic, distance…and, downtown Seattle; exhaustng to me.

You are blessed with your recovery to return to work.

I have no memory of the angios…the last was 5 years ago. Far too long a story; have had two CTAs. To my knowledge, no MRI; however, recently someone mentioned an MRI consent form related to my records. I was really really ill after angios…

The pt info booklets/card-to-carry on the FDA “approved” stents reference MRI’s and expect the new one likely could…based on its available data…questions for the md…
More below…to help keep separtated data…

I am so aware stents (devices) may be “off-label” ; i.e. FDA approved and used in a devised manner… Supposedly when a device is used off-label it is reviewd by an IRB…I stumble here…on the “I” Review Board… which is presumably a local group that reviews/determines the benefit of off-label items and whatever else. It is common knowledge drugs are “off-label” and it is not common in media coverage/websites on devices.

I strongly suggest you call your nuero and ask

  1. if FDA approved , do they have a “pt info booklet” available ?
  2. if in trial, for the written data on it to be provided early for you to research and make an informed decision to participate… in a trial.
  3. if in trial, how long in process, and if any known #'s so far… i.e. how close to meeting the needs of attempting to get the FDA approval
  4. Is the anticipated annual small volume putting it into the FDAs HUD/HDE process?
  5. if it is a “stent”…is it implanted thru the arteries (non-invasive process) to a location in the arteries…or is surgery required like a clip?
  6. anything else you can think of to ask… and, you may have many more questions after reading any available data the neuro may provide to you…

This triggered my thoughts; and, remembered I saw my neuro 08/04 who never mentioned this flow-diverting device… I just left a message on his office #… May be ironic if we have the same neuro, or in same clinic…

Ask your neuro ahead of time every imaginable question…
Much of the treatment overseas, the intiial trials…are provided by our corporations! and, many of those we know, are subsidiaries of a parent in Switzerland, etc…
Like what I mentioned on partent marketing company of a subsidiary that goes thru the FDA process…it is such an easy way to confuse us…

Let me know more… and, when we can plan to meet…and, if you have gone to the local group or plan / want to,…the data on contact/ # is on the BAF site…

Can you let me know when the local group meets, and where?

I really need to be back with my neuro and ask more questions. I was pretty out of it when he came to talk to me after the angio. My doctor is Dr. Louis Kim with Harborview. That is where they took me when the aneurysm burst. I was lucky, as the medics figured it was either an aneurysm or a stroke, so they took me directly to Harborview, instead of Valley General in Renton. They have been wonderful…even though it is a scary place!!
Thanks, Chris

You were blessed to be taken in immediately. Dr. Kim made a presentation at one of our initial support group meetings; and, think he was Beth’s neuro. Beth Dillard has been our group leader for about a year; her tel # is 425-■■■■■■■■; and, she is alwas so helpful. If I recall correctly, Dr. Kim was also her neuro. Beth will better explain the address/location than me…I rely on my gps. Beth generally sends out an early email on the meeting; a follow-up reminder, and/or to explain if a change in the presenters, etc; the next one should be 09/29. There are several garages at Harborview so it can get confusing to some of us!
If you know/remember the name of the artery(ies) treated, look at the circle of Willis on arteries. The 'net has a lot more info on which lobes the artieres feed and more and more.
Look forward to meeting you one of these days…

Hi Christie, I have 4 pipeline embolizatation devices in my internal carotid artery that had a 10mm X 31mm dissecting aneurysm. This is the newest stent out and many trials in South America and Europe. Search Chestnut Medical and pipeline embolization device, in 2012 most aneurysms will be fixed with these new stents! Had the surgery at Mayo Clinic 12/29/10, 1 of 2 places doing trials. I missed the trials but my surgeon went to the FDA for compassionate use approval as it was my only hope. 100% successful! Any questions you can email me @ ■■■■■■■■■■■■■■■■■■■■



I think Rick is right. Your doctor might be referring to the Pipeline embolization stent. My doctor discussed this option with me but he didn’t think I should wait until it was approved. So we went ahead with a more traditional stent and he said if it needs to be redone down the line he would use the pipeline. (After actually doing the procedure with the traditional stent, he’s more optomistic that this may be a permanent solution. So I’m keeping my fingers crossed) Anyway, h e said it was submitted to the FDA for expedited approval and he thought it would be approved in 4 - 6months and that was back in July 2010. My understanding of the pipeline is that it’s expected to be a more permanent solution but my doctor did mention that there were problems only with people who had “giant aneurysms” having more strokes from the procedure but for smaller aneurysms it was very promising.

Thanks so much for the info. I have been in contact with Rick (thanks Rick for all the input). It sounds like if I get to the point that I really need the stent before it is approved, there is an avenue to do this. I’ve talked again to my neurologist and was told it was probably another 6 months. So, I’m counting on May of 2011. If anyone hears anything differently, please let me know!!

Thank you all so much—it is just so nice to know I’m not alone with the mess in my head!!!


Dear Christie,

I also have a large anuerism; the request for a compassionate use of the Pipeline Embolism Device was submitted back in January. Approval was just granted and I am now scheduled for the procedure on April 14th at NYU in New York City.

There is a very interesting article that Chestnut submitted on February 1st to the FDA as a follow up to their initial application for approval . The article was originally a confidential document but the FDA has blacked out all of the names of the people and have made it availble on their website. The document is about 60 pages long but there is a table toward the end of the document that has a number of statistics that you may find to be quite comforting.

Also the FDA advisory board voted unamiously to approve the device in mid March. Typically final approval usually follows this by 3 to 4 months. Therefore the device should be generally available to anyone in the US this summer.



Hi Fred

Sending prayers and good thoughts your way. I had my aneurysm coiled and stented in August 2010. Had my 6 month follow up and everything looks great and I feel perfectly fine. Hope this helps to keep you optomistic


Dear Joanne,

I am so happy to hear that you are perfectly healthy now. Thank you so very much for your response.

Everyone's thoughts and prayers are working. They have been doing a lot to keep me optomistic and they are also working on the FDA.

I just received fantastic news, the FDA approval has come through and am now scheduled for the Pipeline to be implanted on the 14th of this month up at NYU in New York City.




Thanks so much for the information. Is there a website where I can get all the info?

My thoughts and prayers are with you on April 14th....please let me know how it goes. I'd like to hear about the procedure and what it entailed (I'm a detail kind of person and like to know before hand what to expect).

Thanks again for responding. My thoughts are with you.


Hi, I am just collating info for later. I am trying for the best possible procedure to fix these annies. I hope you can shed some light on stents or are they better than just coiling.