Introduction-Extensure info please

[labfish]

I am currently scheduled for Extensure surgery on July 20th via minimally invasive procedure on L3-L4 and L4-L5. I can't find anything about this particular "spacer" or ADR. I will be meeting the surgeon for the first time this Thurs., July 12th. He is extremely well recommended. Former Spinal Surgery director for the Navy in Newport News, well recommended by OR staff, etc. I have the feeling he is a very advanced surgeon who is now in private practice and operating 3 days a week. It has taken 5 months to go through the process of finally getting a date. Supposedly, I will only be off work 2-4 weeks. I'm going to try for 6 though.

Has anyone had any experience with minimally invasive or heard anything about Extensure? It is made by Nuvasive who also make minimally invasive instruments.

I have bunches of questions for this surgeon and I understand he will take all the time in world to answer them. They even inform you in their packet that you may have to wait a while when you finally are scheduled to meet with the dr., because the patient ahead of them may have many questions also and that you will get your chance and have as much time as you need. No rushing on to the next patient.

Any information will be greatly appreciated. I will update my signature and info when I get a chance. I just discovered this site today.

Thanks for any info.

Labfish
"BAD BACK" more details to follow
post steroid injections, PT, etc.

[Ouch!]

Labfish,

Welcome to the forum.

I have not heard of Extensure surgery before. Please update us on what this is and what you found out on your doctor visit today.

Jane

[Harrison]

Yo Labbie, thanks for finding us. This seems like a new device for many of us; so, I looked into it a little bit. Here’s a good overview of the companies making lumbar spacers; let me know if you want the full text article:

Interspinous Process Devices in the Lumbar Spine. Journal of Spinal Disorders & Techniques. 20(3):255-261, May 2007.

Bono, Christopher M. MD ; Vaccaro, Alexander R. MD
A growing number of interspinous process devices have been introduced to the lumbar spine implant market. Implant designs vary from static spacers to dynamized devices. Furthermore, they are composed of a range of different materials including bone allograft, titanium, polyetheretherketone, and elastomeric compounds. The common link between them is the mechanical goal of distracting the spinous processes to affect the intervertebral relationship. In contrast, the purported clinical goals are more variable, ranging from treatment of degenerative spinal stenosis, discogenic low back pain, facet syndrome, disk herniations, and instability. Though some clinical data exist for some of these devices, defining the indications for these minimally invasive procedures will be crucial. Indications should emerge from thoughtful consideration of data from randomized controlled studies.

From the Nuvasive financial news press release:

http://www.freshnews.com/news/biotec....html?NuVasive

ExtenSure - an interspinous dynamic stabilization and fusion system allowing decompression through a more natural restoration of the spinal anatomy. ExtenSure's primary indication is for lumbar spinal stenosis.

From the FDA:

http://www.fda.gov/cdrh/510k/sumdec05.html

DEVICE: NUVASIVE COROENT EXTENSURE SYSTEM
NUVASIVE, INC. 510(k) NO: K052210(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE CT. SE DECISION MADE: 12-DEC-05
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA

I looked at the Nuvasive web site, but I am too stupid to be able to find the information that should/maybe on that site. Please let us know what secrets are unveiled….

By the way, let us know when your birthday is…we’ll chip in and buy you a leather bathrobe for those nasty staircase adventures…

[labfish]

I've now got a lot more info. This Extensure or Extendsure is a "spacer" made of some sort of plastic that is inserted between the vertebrate after all the junk that is compressing the nerves is removed and, in my case, a lamenotomy (partial removal of the lamina. This spacer keeps the vertbrate separated. It was approved by the FDA in 2005 I think. This particular dr. uses minimally invasive surgery. It will be a long procedure. I'm looking forward to the day after surgery. Because he uses a gel-like "glue" made with bone matrix to secure these "spacers." My bone is supposed to join with this stuff and form a more flexible fusion. Then he uses Dermabond for the external closure. He says I can shower the next day-just don't soak in a tub. The worst part I understand is making yourself take it easy because you have no pain. He says I will see a great improvement and that he's not sure how I'm still walking with the severeness of my stenosis in L4-5 and L3-4. I've asked to be off for 6 weeks so I can have some sinus surgery a month after the back surgery and to enjoy myself, I hope.
I'll keep you up-to-date on my recovery and outcome.

[labfish]

Thanks for the info you sent! I would love to have the whole article if possible. What you sent was definitely more than I've been able to find. There aren't any brochures I guess. The dr. just told me about it and showed me what it looked like. Almost like a Lego piece!

I'll keep you up to date.

Oh, and with the leather robe how about bedroom slippers with treads? Smooth doesn't cut it.

I don't know much about the Extensure, but I am familiar with the X-stop. You can find out more from their website - www.kyphon.com

There also are several clinical studies on the X-stop which you should be able to find online.

Labfish, let me know how everything turns out. Did your doctor give you the option of an X-stop?

Good luck

[labfish]

Well, the surgery did not turn out like it was supposed to. First of all, it took 15Hours! This was because of when he went to decompress L3-L4, I ended up with a complication of "Spontaneous dural rupture with herniation of the neural elements." Basically, I had an explosion of nerves that he had to carefully put back in the spinal cord. Nice. This happened when he started decompressing. The ligament was attached to the laminae. etc. In the end, I ended up with only 1 extendsure at L2-L3. So much had to be removed at L3-L4 and L4-L5 that the space was too large for an extendsure. Needless to say, recovery has been a little slow. My mind says I'm 25 but my body says otherwise. I may need further surgery later to stabilize the spine. Also I may need my sacroiliac joint injected. It has been a little over a month and am down to 2-3 vicodin a day. I have a total of 6 weeks of Short Term Disability but may ask for a little more of it. Don't want to rush it, I guess.
As far as I can tell, the Extendsure has not been a problem at all. Since 3 levels are involved it's hard to tell. They are not making the implants large enough for major clearing out.
I'll keep you all posted of any other developments.

[cathydownunder]

sounds like you had a bit of a rough ride during surgery, thank goodness we're unaware of what happens to us while we're "out".
I'm curious...if you had the extensure only at L2/3 what was done between your other discs (L4/5 & L3/4)? Have you been fused, had a disc replacement or something else done?
1 month post-op can be a very frustrating time in the recovery process, you're starting to feel better (usually)but you've still got a lot of healing to do yet. Don't rush anything and keep taking the pain meds as long as you need them,
It'll be interesting to hear your progress with such a new procedure, hope all goes well.

[labfish]

As of now nothing has been done to L3-L4 or L4-L5. He wants to wait about 3 months to see if I'm "stable." I remember hearing him say at some point right after surgery that fusion could be done with "loops and knots." I of course may have been a little fuzzy. He doesn't like traditional fusion as it is hard on neighboring vertebrate. I know the PA in his office said he has been doing a lot of fusion revisions.
My pain now is primarily in a new place. He told me over the phone that it may be the sacroiliac joint and that can be injected to settle it down. The new alignment and decompression makes other out of whack areas let you know they are there. We'll see. I don't have very much pain in my legs now. Intermittent and different so that is nice. I'll keep this updated as time goes on.