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VAX-D® Seminar Handout
This document was distributed in 1999 as a 2-page handout at a presentation
to an insurance group given by VAT'-TECH medical director Frank Tilaro,
M.D. The FDA's 510K clearance to market the device does not permit the
manufacturer to represent that VAX-D therapy affects disc metabolism or
is "approved for lumbar disc herniations, degeneration,
by effecting lumbar decompression," as stated below.
COMPARISON VAX-D vs TRACTION
| VAX-D |
TRACTION |
| Function |
Function |
- Negative intradiscal pressure.
- Mechanical effect -- capitalizes on the thixotrophic properties of
the nucleus pulposis.
- Diffusion gradient -- effect on biochemical and
biophysiological aspect of disc metabolism.
|
- Intradiscal pressure may/may not be Reduced, not negative.
- Cannot capitalize on the thixotrophic properties of the nucleus pulposis.
- Diffusion gradient not effected may actually be decreased.
|
| Use |
Use |
- Treatment last 30-45 minutes.
- Treatment requires 1:1 monitor by a trained, certified staff member
under direct supervision of medical doctor.
- Treatment is a medical procedure that needs to be adjusted and controlled
throughout the session.
- Cost of purchase $125,000
- Treat only discogenic pain syndromes.
- Patient selection: Only unresponsive lumbar discogenic pain syndromes.
Must have tried at least 6 weeks of previous conservative care and not
be progressing.
|
- Treatments may last minutes to 15 minutes.
- Treatment may/may not require any supervision.
- Receives only patient subject response as monitor and requires little
to no adjusting during session.
- Cost to purchase: 0 - $7,000.
- Typically contraindicated for lumbar discogenic pain syndromes also
used for lumbar strain/sprain.
- Patient selection: first tier treatment rendered on day one of the
condition.
|
| Studies |
Studies |
- FDA approved for lumbar disc herniations, degeneration,
by effecting lumbar decompression
- Published study proving it effects negative pressure in lumbar discs
in live patients. (1)
- Outcomes study: 70% success on unresponsive lumbar
discogenic pain syndromes in over 700 patients' trial. Average length of
condition prior to treatment nearly 3 years. 90% had some improvement.
(2)
- Objective neurologic improvement obtained using VAX-D. (3)
- Four published studies in peer reviewed journals 1,2,3,4.
|
- Not FDA approved to treat herniations, degeneration by decompressing
the lumbar discs.
- No published study proving negative pressure in lumbar discs in live
patients. Some studies indicate traction increases disc pressure.
- Studies not on long term disc sufferers. Studies available show equivocal
results.
- Does not effect lumbar decompression.
|
- Dozens of lower Courts as well as all appellate court decision have
upheld that VAX-D is different than traction.
- Medical Technology Group (5) National utilization and review company
that reviews new technologies and reports findings to subscribing insurance
companies. After an extensive study, they published a four part review
of their findings.
- VAX-D is different than traction and should have a separate identifiable
code and separate relative value.
- BLUE CROSS/ BLUE SHIELD OF MINNESOTA
Has offered VAX-D providers a contract with a different relative value
and procedure code than traction.
- Relative Value for Physicians (RVP) (6) the most widely used proprietary
relative value system. The only independent relative value source established
other than medicare. Utilized by approximately 50% or insurance companies/HMO's
to determine reimbursability. Has established a preliminary code, separate
from traction, in January of 1999.
- Has established a relative value of 28 compared to traction which is,
6 after extensive review of the technology.
- Based criteria on
- Time it takes.
- Skill involved.
- Risks to patient.
- Risks to provider
- Severity of illness.
- Written opinions of two local Medical Doctors whom we utilized for
case studies.
- No previous U & R has been performed locally, regionally or nationally
by ally independent entity that continues to describe as traction after
review of all data.
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This article was posted on May 4, 2000. |