Free Republic
Browse · Search
News/Activism
Topics · Post Article

Skip to comments.

FDA approves implant for spinal pain
Seattle Post-Intelligencer ^ | November 22, 2005 | THE ASSOCIATED PRESS

Posted on 11/22/2005 9:02:50 PM PST by neverdem

WASHINGTON -- People who suffer from a spinal problem that can cause back and leg pain have an alternative to difficult surgery with a newly approved device that requires a much less invasive procedure to implant.

The Food and Drug Administration authorized use of the "X-stop" - a thumb of titanium on a mount that fits to a vertebra in the lower back - to reduces pain from lumbar spinal stenosis. The FDA's approval was announced Tuesday by the St. Mary's Spine Center in San Francisco, which developed the device.

The condition is the most common cause of back surgery in people over 50. It occurs when the tube for nerves in the spine becomes constricted as a person ages. Pain, numbness and weakness usually manifest by standing up; it is often relieved when sitting down.

Previously, the condition could be treated with physical therapy, anti-inflammatory drugs and injections, or by a laminectomy, a difficult surgery that involves full anesthesia and the removal of parts of bone and tissue to open up the canal in the spine.

The X-stop achieves a similar effect by pressing against parts of either side of a vertebra, pushing open the tube without removing any of it.

"By wedging those bones apart, the tube is indirectly opened up," said Dr. James Zucherman, who invented the device. He is the medical director of the St. Mary's Spine Center. "The bones don't collapse on the nerves like they did before. The patient doesn't have to bend over to protect the nerves."

Because it is implanted so close to the surface of the skin, it usually requires only local anesthesia to insert. People may have up to two of the devices implanted on vertebrae in the lower spine.

Zucherman, who has overseen the implantation of more than 100 of the devices during trials, said he will recommend it to most people with the condition who don't benefit from physical therapy and drug treatments. He will only recommend a laminectomy if the device doesn't help.

However, FDA documents released last year before a public hearing on the product raise concerns that the X-stop's effectiveness decreases over time, saying studies found that about 15 percent of patients who had the implant reported symptoms returning.

"It appears that the X-stop is effective to about a year and then begins to decline," the FDA said.

Dr. Zucherman disputed those figures, saying the percentage of implant patients reporting a dropoff was about half that - and that people who received only therapy and drug treatments reported a much greater rate of symptoms returning.

The documents also say roughly 50 percent of people who received the implant said they had a significant relief of all symptoms related to stenosis, as opposed to 5 percent who reported relief from nonsurgical treatment.

Zucherman pointed to another figure provided to the FDA - that 73 percent of patients who received the implant reported being satisfied with it after two years. People who underwent laminectomies report similar success rates, he said.

The treatment is also less expensive than the more invasive alternative. Implanting a single X-stop costs about $17,000; implanting two costs $24,000, he said. A laminectomy is about $50,000.

About 4,000 X-stop devices have been implanted around the world, he said. Versions of the device are already available in Europe and Japan. About 400,000 Americans are affected annually by lumbar spinal stenosis.

Zucherman said he invented the device in 1997 after watching a patient who received a successful laminectomy become mentally disabled - he couldn't remember where he was moment to moment - because of the full anesthesia used.


TOPICS: Business/Economy; Culture/Society; Extended News; Government; News/Current Events; US: California; US: District of Columbia; US: Maryland
KEYWORDS: backpain; fda; health; implant; legpain; medicine; pain; spinalimplant; spinalstenosis; spinepain

1 posted on 11/22/2005 9:02:51 PM PST by neverdem
[ Post Reply | Private Reply | View Replies]

To: neverdem
"The treatment is also less expensive than the more invasive alternative. Implanting a single X-stop costs about $17,000; implanting two costs $24,000, he said. A laminectomy is about $50,000."

I think I'll go with my limp.

2 posted on 11/22/2005 9:11:33 PM PST by sageb1 (This is the Final Crusade. There are only 2 sides. Pick one.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: neverdem

Wow, what a timely post to pass to an uncle contemplating surgery. Thanks for posting it.


3 posted on 11/22/2005 9:25:45 PM PST by parisa
[ Post Reply | Private Reply | To 1 | View Replies]

To: El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; ..
No new hips or knees for fat patients (UK)

Mildly Depressed People More Perceptive Than Others

This Is Your Brain Under Hypnosis


William Duke


Don Hogan Charles/The New York Times
SEEING RED Dr. Amir Raz, rear, and Miguel Moeno demonstrate the hypnosis test.

FReepmail me if you want on or off my health and science ping list. Anyone can post any unposted, unrelated link as they see fit.

4 posted on 11/22/2005 9:29:08 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: sageb1

What will you do when you can't even limp sit, stand, lay down, bend down, take a crap?

If your problem is managable, certainly, avoid surgery. It's risky. But if your condition gets worse, you have to do something about it if you want to have any sort of life worth living. Trust me, it isn't pleasant to be in that much pain 24 hrs a day. (thank God for oxycontin!!)

I hope you never degenerate to the point where you need surgery, but at least you know it's available, and now a less risky one is an option as well. I'll have to ask my Doc about this, as i'm long overdue for a third operation.


5 posted on 11/22/2005 9:31:06 PM PST by Forte Runningrock
[ Post Reply | Private Reply | To 2 | View Replies]

To: Ethrane
Zucherman said he invented the device in 1997 after watching a patient who received a successful laminectomy become mentally disabled - he couldn't remember where he was moment to moment - because of the full anesthesia used.

How often does that occur with general anesthesia, or is full anesthesia different from general anesthesia, and what is the term for it besides amnesia?

6 posted on 11/22/2005 9:34:52 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 4 | View Replies]

To: neverdem

These are some really good articles. Thanks! My undergraduate degree is in psych, so I love this stuff.

I guess we're all sort of arm chair psychologists anyway.


7 posted on 11/22/2005 9:43:16 PM PST by phantomworker (A new day! Begin it serenely; with too high a spirit to be encumbered with your old nonsense!)
[ Post Reply | Private Reply | To 4 | View Replies]

To: parisa

You're welcome!


8 posted on 11/22/2005 9:44:50 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 3 | View Replies]

To: Forte Runningrock

I'm not discounting the benefit. I'm just being cranky.


9 posted on 11/22/2005 9:45:56 PM PST by sageb1 (This is the Final Crusade. There are only 2 sides. Pick one.)
[ Post Reply | Private Reply | To 5 | View Replies]

To: neverdem
All anesthesia carries with it a potential risk. Because of the nature of this surgery, because they have to actually move the spinal cord slightly, they put you under deeper, near death. If you were to twitch when they touched a nerve with sharp scalpels in there, you could end up paralyzed, or some other loss of function.

It's not only brain damage you risk, loss of bowl/bladder control, loss of kidney function, full or partial paralysis, anything in the spinal cord nerve bundle in that area which could be damaged.

I don't know what the rate is for anesthesia reactions, somewhere in the neighborhood of 1 in a 1000, while risk of nerve damage from the older laminectomy method is 1 in a 100. At least that's what my surgeon told me. This new method sounds much better, and has simular sucess rates.
10 posted on 11/22/2005 9:47:23 PM PST by Forte Runningrock
[ Post Reply | Private Reply | To 6 | View Replies]

To: Forte Runningrock

I know what you mean. I had back surgery twice with good results. Having a bulging disc and sciatica is a horrible experience even with prescription pain medication.


11 posted on 11/22/2005 9:48:33 PM PST by Odyssey-x
[ Post Reply | Private Reply | To 5 | View Replies]

To: sageb1
"I'm not discounting the benefit. I'm just being cranky."

LoL! I understand completely. One the bright side, the surgery (if it's successful) will pay for itself in a couple years with the money you save on meds.

12 posted on 11/22/2005 9:52:26 PM PST by Forte Runningrock
[ Post Reply | Private Reply | To 9 | View Replies]

To: neverdem
Promising!
13 posted on 11/22/2005 9:52:35 PM PST by kstewskis ("Thank you ladies and gentlemen, you've been a wonderful audience" ...Rocky Rhodes)
[ Post Reply | Private Reply | To 1 | View Replies]

To: Forte Runningrock
My brother started to have back problem in 12-04. He walked like a 80 year old man. His legs were always numb and he was always in pain.
He went back to Peru where we came from and it took him 9 month to decide to have surgery after all kind of treatments, Chiropractors, thermal bath, acupuncture, etc.

He was operated by two doctors and one to supervise the two. Good doctors. Peruvian doctors have good reputations. I had a major surgery there too.

The beauty of all this, no only my brother is completely heal, and walking without pain and straight, but it only cost him $5,000 dollars. The surgery took 4 hours. It was supposed to take 2 hours, but since my brother was premi. there was something else that needed correction .

I must add, prayers also works. He was very afraid to have the surgery but I prayed over that fear because the doctors told him that if he waited, it would be worse since he is now 62 years old.

Thanks to the doctors in Peru and to JESUS!!!!!!!! my brother is heal and in good spirit. P.S. one of the doctors was related to one of my brother's friend. That explain the cost but it's cheaper there even if you don't know a doctor. Maybe a few thousand more, no more than 8 K
14 posted on 11/22/2005 9:56:32 PM PST by Lily4Jesus ( Jesus Saves)
[ Post Reply | Private Reply | To 5 | View Replies]

To: Forte Runningrock
"LoL! I understand completely..."

I figured you would. Anyone with chronic pain usually does. Thanks for the info (All - neverdem)

Sidenote: I remember going to hockey games with my littlest angel whose feet stuck straight out from her chair. Everytime she moved, her feet nudged the seat in front of her. One night, the lady who sat in that chair turned around and said, "Would you PLEASE keep your daughter still?" I thought the lady was a real beatch...I understood a lot more when I started having problems. (I would like to think I'd be more pleasant than that lady was, though).

15 posted on 11/22/2005 10:01:32 PM PST by sageb1 (This is the Final Crusade. There are only 2 sides. Pick one.)
[ Post Reply | Private Reply | To 12 | View Replies]

To: Lily4Jesus

I've has 2 on my back so far, plus others on my legs.

No matter haw many surgeries a person has, each one is just as worrysome as the first. I guess it because in the back of your mind, you know you are playing the odds.

You are right, a person can develop permanent nerve damage and other serious problems if it isn't watched and treated properly.

Glad your brother is doing well.


16 posted on 11/22/2005 10:09:29 PM PST by Forte Runningrock
[ Post Reply | Private Reply | To 14 | View Replies]

To: neverdem

About 4,000 X-stop devices have been implanted around the world, he said. Versions of the device are already available in Europe and Japan. About 400,000 Americans are affected annually by lumbar spinal stenosis.
---

Thanks FDA for finally allowing us citizens to finally use this if we so choose. /s

Can you please add me to your health/science ping.


17 posted on 11/22/2005 10:09:57 PM PST by traviskicks (http://www.neoperspectives.com/gasoline_and_government.htm)
[ Post Reply | Private Reply | To 1 | View Replies]

To: neverdem
This Is Your Brain Under Hypnosis: The probe, called the Stroop test, presents words in block letters in the colors red, blue, green and yellow. The subject has to press a button identifying the color of the letters. The difficulty is that sometimes the word RED is colored green. Or the word YELLOW is colored blue.

Remember the Stroop test? That was fun. It says a lot about perception.

18 posted on 11/22/2005 10:10:51 PM PST by phantomworker (A new day! Begin it serenely; with too high a spirit to be encumbered with your old nonsense!)
[ Post Reply | Private Reply | To 4 | View Replies]

To: sageb1

"A laminectomy is about $50,000."

That seems a bit steep. I had a four level lumbar spinal fusion done with two rods and eight screws three years ago, and it ran just over 75 grand. (where they removed bone fom hip for graft has given the most pain)

Had two laminectomies done about five years apart back in the 80's. They helped for a few years, then things deteriorated to the fusion thingy.


19 posted on 11/22/2005 10:26:07 PM PST by Ursus arctos horribilis ("It is better to die on your feet than to live on your knees!" Emiliano Zapata 1879-1919)
[ Post Reply | Private Reply | To 2 | View Replies]

To: Ursus arctos horribilis

How are you feeling now?


20 posted on 11/22/2005 10:28:15 PM PST by sageb1 (This is the Final Crusade. There are only 2 sides. Pick one.)
[ Post Reply | Private Reply | To 19 | View Replies]

To: neverdem
Was explained to me that when a full anesthesia is used, except for the heart, for all intents and purposes, one is completely paralyzed. Under a general, one just goes to sleep.
21 posted on 11/22/2005 10:31:51 PM PST by Ursus arctos horribilis ("It is better to die on your feet than to live on your knees!" Emiliano Zapata 1879-1919)
[ Post Reply | Private Reply | To 6 | View Replies]

To: Lily4Jesus

Glad to hear all went well for your brother, and yourself.


22 posted on 11/22/2005 10:35:04 PM PST by Ursus arctos horribilis ("It is better to die on your feet than to live on your knees!" Emiliano Zapata 1879-1919)
[ Post Reply | Private Reply | To 14 | View Replies]

To: sageb1

When compared to pre surgery, pretty good actually. Bad backs and pain are a constant, but it is all in the degree of pain, at least now I am mobile and able to have a life. I have become much more physically active and lost a lot of weight, which has alleviated several other medical problems


23 posted on 11/22/2005 10:54:25 PM PST by Ursus arctos horribilis ("It is better to die on your feet than to live on your knees!" Emiliano Zapata 1879-1919)
[ Post Reply | Private Reply | To 20 | View Replies]

To: Ursus arctos horribilis

I'm happy to hear that. May you have a blessed and Happy Thanksgiving.


24 posted on 11/22/2005 11:04:44 PM PST by sageb1 (This is the Final Crusade. There are only 2 sides. Pick one.)
[ Post Reply | Private Reply | To 23 | View Replies]

To: nutmeg

bttt


25 posted on 11/22/2005 11:07:45 PM PST by nutmeg ("We're going to take things away from you on behalf of the common good." - Hillary Clinton 6/28/04)
[ Post Reply | Private Reply | To 1 | View Replies]

To: Ursus arctos horribilis; Forte Runningrock; traviskicks
Thanks for the feedback. I'm just a curious FP doc. It appears to restrict extension between the spinous processes of adjacent vertebrae.

26 posted on 11/22/2005 11:21:21 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 21 | View Replies]

To: parisa

Check the pic in comment 26.


27 posted on 11/22/2005 11:24:05 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 26 | View Replies]

To: neverdem

thanks for that pic, quite interesting! From the looks of it, I might guess there might be quite a bit of complication regarding the displacement of multifidus and erector spinae muscles in that area. or? And I wonder how soft that middle part is...


28 posted on 11/22/2005 11:44:56 PM PST by traviskicks (http://www.neoperspectives.com/gasoline_and_government.htm)
[ Post Reply | Private Reply | To 26 | View Replies]

To: neverdem; Ursus arctos horribilis; Forte Runningrock; traviskicks
I've had 3 lumbar procedures, the last a Knodt Rod Fusion L4 - S1. The Knodt rod clamps on each side of the vertebra stabalizing the spine while the donor bone fuses(see photo). Also included a body cast for 6 weeks (hips to low chest). Pain is managable, but playing baseball etc with grandsons is out, but at least I'm no longer falling down.
29 posted on 11/22/2005 11:48:01 PM PST by Diver Dave (Pray for our Armed Forces as if your freedom depends on it.)
[ Post Reply | Private Reply | To 26 | View Replies]

To: sageb1

I have a new product that helps a lot. If you are interested I could send you some


30 posted on 11/23/2005 7:18:57 AM PST by STD (Delete)
[ Post Reply | Private Reply | To 2 | View Replies]

To: neverdem

Weird! It looks like a device for sizing to shape a very large nose! :o)

Happy Thanksgiving.


31 posted on 11/23/2005 8:45:00 AM PST by parisa
[ Post Reply | Private Reply | To 27 | View Replies]

To: neverdem

I have NO IDEA what that statement means. 'Full' anesthesia is not a term I've seen used previously.

General anesthesia means simply 'unconsciousness' in laymen's terms, which is associated with a loss of the body's protective reflexes (such as airway maintenance for example).

As far as someone becoming 'mentally disabled' after a general anesthetic, I would say that that should never occur in the absence of a catastrophic event such as brain ischemia or a stroke. Elderly people do on occasion however have a temporary decline in mental status after general anesthesia (which some studies suggest can last weeks), but the cause is probably multifactorial (debilitated state, cerebrovascular disease, pre-existing mental deterioration and severity of illness coupled with a difficult or prolonged anesthetic).

But that statement you quoted makes no sense to me at all.


32 posted on 11/23/2005 8:40:40 PM PST by Ethrane ("semper consolar")
[ Post Reply | Private Reply | To 6 | View Replies]

To: Ethrane

Thank you very much. Happy Thanksgiving!


33 posted on 11/23/2005 8:54:33 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 32 | View Replies]

To: Ursus arctos horribilis; Forte Runningrock; traviskicks
You might be interested in Ethrane's reply in comment 32 about "full anesthesia". Happy Thanksgiving!
34 posted on 11/23/2005 9:06:08 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
[ Post Reply | Private Reply | To 33 | View Replies]

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
News/Activism
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson