Posted on 10/27/2004 4:49:06 PM PDT by neverdem
The Food and Drug Administration yesterday permitted a unit of Johnson & Johnson to market an artificial spinal disk in the United States as a new form of treatment for people with severe lower back pain.
The disc, called the Charité (pronounced shar-ee-TAY), represents the first of a wave of such devices that are expected to become available over the next decade as an alternative to spinal fusion surgery.
Spinal disk implants are projected to become a billion-dollar market for medical device companies in the next decade, although many orthopedics researchers think that artificial disks will eventually be overtaken by less invasive treatments.
Johnson & Johnson will market the device for use only in the portions of the lower spine for which it has F.D.A.-approved clinical data. Surgeons say the device, which consists of a high-density plastic sandwiched between two metal plates, can be used only on patients with relatively strong bones.
Disks are gel-like cushions that separate the bones of the spine. In spinal fusion, surgeons insert metal plates or rods into the bones of the spine above and below a failing disk to hold them in place.
Then bone material is inserted so that the spinal bones become fused. More than 200,000 Americans undergo spinal fusion annually for pain relief from disk degeneration in the lower spine.
Orthopedic surgeons and medical device companies are excited about the potential of artificial disks because patients recover more quickly and have more freedom of movement than after spinal fusion. In addition, spinal fusion typically puts additional pressure on the disks above and below the fused segment of the spine, which often leads to the need for more back surgery.
"The idea of the disk is very appealing," said Dr. John A. Boockvar, assistant professor of neurological surgery at New York Presbyterian Hospital/Weill Medical College of Cornell. Dr. Boockvar said that cervical disks, which could be inserted in the neck portion of the spine and are under development at several companies, would be an even more welcome development because freedom of movement was more crucial for the neck.
DePuy Spine, the Johnson & Johnson unit that will market the Charité, is based in Raynham, Mass. DePuy acquired the rights to the Charité when it paid $325 million last year for Link Spine Group. The Charité has been implanted in thousands of European patients since the mid-1980's, after it was developed at the Charité Clinic in Berlin.
Analysts said that DePuy would have the domestic market to itself for as long as two years but that it would face strong competition in the long run from Medtronic, Synthes-Stratec and other device makers.
Lawrence Keusch, who follows device companies for Goldman Sachs, estimated that disks for the lower spine would take no more than 20 percent of the lumbar spinal fusion market, generating $340 million in revenue, and that sales would initially be slow because so few surgeons have been trained to do the implants.
Maybe sKerry can get some kind of backbone afterall.
I was thinking of Sen. Republicans.
Yup! What you said. ;-)
This is good news for those of us who suffer with deteroited disc..of Osteo Arthritis.
I have two of these, one at L4/L5, and another at L5/S1. I had it done in France a over a year ago by the man who invented the Prodisc.
I suffered a bad accident when I was young and a result dealt with over ten years of lower back pain.
This operation has taken away all the bouts of crippling back pain I used to endure every month or so and has done quite a bit to reduce the day-to-day pain I used to experience (though it's not perfect).
This was a god send for me, I hope other people are helped.
FReepmail me if you want on or off my health and science ping list.
I wish I had known of this procedure 2 months ago. I am recovering from a spinal fusion. L3-4 and L5-6, if I'm not mistaken. I don't think I will ever have the flexibility back.
I'm glad to read that you were helped. You might be surprised to learn that there are a fair number of folks walking around with disc space narrowing on various images of their spines - and presumed herniated discs - who don't have any complaints. Spinal fusion seems somewhat gruesome.
LOL! So what is political about it? It's from the business section.
I'm thinking good news for lawyers.
I know that, back pain is a tricky thing, and the cause is not always as easy to discern as the surgeons let on. I know of people who have had disc replacement and haven't been helped at all and some, like me, who have gotten relief.
In, my case, I briefly lost sensation in my legs because of an accident while playing ice hockey that caused a severly herniated disk. I immediately got my legs back after the surgery but was stuck with chronic back pain from that point on. So I sort of have a different case than the typical sufferer. I considered having fusion, but am glad I held out.
From what I understand it takes quite a bit of time to recover from a fusion and to fully know what the benefits will be, so don't draw any conclusions too soon or give up hope.
One of the things I appreciated about the disc replacement was that the recovery time was much less that the fusion and it still took me about three months before I started to feel better and feel improvements.
I was lucky to have a surgeon who was involved in the clinical trial with disc replacements to tell me about the procedure. Many people are helped by fusions though, but like I said it can take time.
"This is good news for those of us who suffer with deteroited disc..of Osteo Arthritis."
Too late for me, lumbar spine is fused at four levels with rods and screws. Still have hell with pain and the first disc above fusion is now starting to fail. Maybe can use it there?
Literally, I have tears in my eyes. Sounds silly, but when you have lived with the kind of pain I have for two years -- when you can't bathe your children, pick them up, play with them.....
I have four blown disks in my neck and thoracic spine -- and I'm only 38 years old. I've held out for the artificial disks because I have already had one cervical discectomy and fusion and the disks around it collapsed a couple of years later thanks to degenerative disk disease.
It appears that the cervical disks will be available next, then the thoracic.
Can't tell you what hope this gives me. I am absolutely worn out from the pain, the non-stop medication, the shots........
Good luck!
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