I was diagnosed with a 20 x 30 mm fusiform aneurism in mid January. I had two procedures that were unsuccessful and have been told that my only option is a Pipeline which is not yet approved by the FDA. A compassion use request was made in late January; I was told we should have approval in 2 or 3 weeks. So far I have heard nothing from the manufacturer, the FDA and little from the doctor.
I have now consulted with 4 neurosurgeons; have received conflicting data from them and have also searched the internet which I found very upsetting with more conflicting data. The data I do find is dire. So far the variety of survival rates seems to vary with my chance to make it to the end of the year as low as 10% to a high of 80%.
Last week I learned from a 4th Neuro interventionalist that the device is now no longer available in the US. But it may be available in Argentina or Canada. Also I found that 8 of the 9 members of the FDA neurological devices advisory panel voted unanimously to approve the device on March 18th. But I have no indication how long it will take for the final approval to be given of if it will ever be approved. Can anyone tell me when the device may be available to me via Compassionate use; how long does the FDA typically takes to approve a device; or should I plan on traveling overseas immediately?
I have so many questions and so very few answers. Can anyone help? What would you recommend as a next step? My research is full of conflicting data and I am at a loss as to what is correct?
I would like to try to determine what my chances of success would be by proceeding as soon as possible, or whether to wait until more information is available, or to do nothing and wait for the big surprise. I believe my chances are slim and my situation is dire and urgent but I am just not sure.
If you have had the Pipeline implanted, what have you experienced. What was your recovery time, and any disabilities following the surgery?
Fred, welcome and I hope you can get / find more data...
Have you already corresponded with the manufacturer and FDA; did your neuro submit the compassionate use request?
Who is the manufacturer?
Prayers to you for your success...
I have tried but to no avail.
When I hadn't heard anything after the first three weeks of waiting for the Compassionate Use Request to be approved I called my doctors office and was told he was on vacation. Then called the manufacturer, ev3, and after a bit of being passed around to differnt people was told that my doctor would be meeting with the president of the company and my doctor would be getting back to me. He did and chastized me for bothering ev3; he told me that this process is a very delicate one and that he had to interced on my behalf.
I had also contacted my congressman to see if he could update me on the process. His office responded that FDA had not even received a request. I called for another update last week and am awaiting their response.
I am not sure what the process is and do not want to bollox it all up but the waiting has become quite stressful.
Do you have any recomendations on what is appropriate to do in this situation?
Thank you for your thoughts, prayers and guidance,
I was considered for a pipeline procedure in Toronto Canada but ruled out as a suitable candiddate. This was aprox. 1 year ago and I think it was in the "researching" stage even though they had done some. I'm surprised to hear USA does not have it approoved since us eskimos usually lag behind you guys. Sorry I cannot help you further.
Try accessing the FDA HUD/HDE site... Humanitarian Use Device and Humanitarian Device Exemption... put H060001 in search as it brings up all of the approved devices... the small annual usage devices...In the fda search site put in ev3 Pipeline and it will take you to some data... address of one ends w/NeurologicalDevicePanelUCM247160 which is dated 02/01/11 w/ref to 180 days...The HDE site, on approved devices, has back-up data... interesting to read the quality of the written data of diff manufacturers. My personal research was on off-label stents... then, on Pipeline, because of others in my region/area awaiting status... of interest, the one page compares Pipeline to Neuroform and Enterprise (# H060001 device) and Onyx...
We, as patients, are not provided data in the same manner as clients/customers...
You may have done all this fda research...or had specific staff to contact...tho you could attempt another...there are names/#'s on the fda sites...there are a lot of different sections/units; one to try may be the registrar.com once you are in fda main access...
Wishing you the best...and, keep us informed...
Thank you I have just begun my searching nad already found a lot more information than i ever hoped to see. i will continue to follow your directions and keep you posted. Here is the link to an update on the pipeline trials: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247160.pdf
Chestnut submitted this to the FDA on 2-1-2011 as an update on the progress of the trials. i found it to be quite interesting and somewhat confusing. I hope this helps others.
Thanks for putting in the correct site... w/my limited learning / memory, it takes me much longer to find / access; then remember to type it correctly.
When you have time, go to the HDE site to learn the broad band of HDE devices...the approval process, the limited study data, the small annual usage, etc. I hope it helps others, too...
If you find out if it is finalized in Canada, Fred may want to visit you...
Craig and Pat,
My understanding is the Pipeline is now available in Canada at the University of Toronto and in Argentina.
It still has not been approved in the US for general use. The estimates now isthat it may take another 120 days until it is available in the US.
Tomorrow I am meeting with another Neurointerventionalist to try to assess the odds of waiting for availablity here or trying to get into the que in Canada, or just waiting. An article written by a Doc at Schands in Gainsville FL said fusiform anuriusms do not normally need to be operated on unless they start to bleed or grow quickly. I have MRI's that show there was no anuerism in September of 2008 but it is now 20 x 30 mm. I am also trying to determine if that is quick growing or not. Perhaps I will find out tomorrow.
Yhank you both for all of your support.
Do you have any idea why you were ruled out of the trials?
Do youhave any idea wha I would have to do to be treated in Canada since I am an american citizen?
Who was the doctor you saw in Toronto? Would you please share his contact information with me?
Thank you, I already been referrered to Dr. Peter Nelson at NYU. He was a participating doctor on the pipeline trials and has requested the Compassionat use for me back in January. So far I am waiting; and confused by conflicitng data and information available. Just don't know what to do; wait for the FDA approval or head off to Canada, or do nothing.
Do you know if either Drs. Barrows or Oglivy have experience with the pipline? I can contact them to see if they may be able to get the approval more quickly.
I believe it was the location that ruled me out. Something to do with it being hard to get to. This did not make sense to me since they frequently coil it but I am not a Dr.
Unfortunately I am unable to remember the Dr's name but if I remember correctly it was St. Michael's hospital which I believe is affiliated with U of T. They do have a web site with department listings. I am not sure I would be comfortable with a procedure in Argentina.
I have no idea how an American Citizen get Cdn. health care. Us Cdns figured out pretty quick that if we want American health care and are wallet is big enough then it is not that hard. I would have to think if your wallet is big enough the same would hold true for you. I do not know this for sure. I would anticipate the procedure to be very expensive - perhaps 100s of thousands of dollars. Again - I honestly don't know.
Sorry I cannot provide you any further information and good luck in your search
Perhapy it was one of these fellows? now that Pipeline is approved there one of these Neuro Doc's at University of Toronto Hospital will help you. I am not sure which of them may be doing Pipeline but here they are: Karel Terbrugge, Robert Wallinsky and Timo Krings. i know the device has been developed only for the carotid arteries so the pnly problem you faced a year ago may be that you anuerism is located in a different area. Now that it is approved there it may be worth your while to follow up on it again.
I was recently discussing the capabilities of different Neuro suregeons and have not been able to determine how they are ranked.
However there is a website that comments about the capabiliites and the quality of different hospitals. I beleive that other may find this to be useful and a good way for people to learn which hospitals have made a name for themselves in different areas of medical expertise. I found a semi annual rating that US News and World report does that was enlighting. here is the link to the latest survey ranking hospital for Neuro surgery: http://health.usnews.com/best-hospitals/search?hospital_name=Hospital+name&specialty_id=IHQNEUR&service_offered=All&city=City&state=&zip=ZIP+Code
None of the above. At any rate I chased the possibility and was eliminated as being suitable for what I think were sound medical reasons. I think the exact reason was they were simply not comfortable getting the device to the location. This is a little hard for me to understand since they have since attempted a stent and it seems they are similiar devices but perhaps the pipeline is "stiffer" or something.
Fred...I am such a slow thinker/comprehender...What symptoms prompted your 2008 MRI?
The limited I know about fusiforms (know just one younger person) is the limtied available data...I am curious as to what symptoms initiated your MRI in 2008???
The worst headache I had ever experienced caused me to go to the ER, they did the MRI then: didn't see anything; gave me a shot of something that numbed me a little and took away the nauseous feeling amd sent me on my way.
I normally never had headaches at all. Whenever I did just an asprin or tylenol and a nights rest and they would be gone. Since January, when the double vision started, I now have one long, continious, chronic headache and a stiff neck.
Hope this helps,
More questions...you note you have had two procedures....
My curiosity goes up...i.e. what do your neuros know about the potential benefits of the new device that would be so advanced from what has already been tried?
The location is large and a juncture; coiling would not work well since they have to sacrifice one of the vertebral auteries. The second attempt was to insert two balloons; one long one between the vertebral and basal and the other to block the other vertebral. Fill the resulting void with onyx and then remove the balloons. A tight seal could not be made and therefore could not safley inject the onyx.
The benefit of the pipeline is they do not have to have a perfect seal and will be able to insert it between the vertebral and basal arteries, forming a open channell. which will eventualy embolize form into a closed channell and with the other vertebral blocked (somehow, I am not sure) the pressure in the anuerism will be reduced substantiallty. When then device thrombus is comple the hopes are that the anuerism will eventually shrink and relieve the pressure in the area. Which another 'hopefully', will allow the return of normal vision and ease the headache and stiff neck.
Hopefully this makes the PED able to be understood a little better.
Hi Fred, only the BEST Dr's are used in medical trials, another friend who had the pipeline in Feb 10 was done by Dr Nelson. You are in the hands of the best of the best.....no worries whatsoever!