VAX-D Part 2 - How it Works
Monday, June 17, 2002 | 963 | 0 | min read
Our first article introduced the VAX-D technology. Next, let's look at the difference between VAX-D and pelvic traction, as well as other treatments.
The Food and Drug Administration (FDA) has twice examined this device/treatment. VAT-Tech, Inc., the manufacturer of the table has had the license for safety renewed annually since 1989 (FDA Registration Number 8022271). VAT-Tech, Inc. submitted an additional 510(k) to secure a license as a decompression device for the spine, which was approved on July 6, 1996 (FDA Registration Number 951622). Therefore, by regulation, VAX-D cannot be considered experimental or investigational.
In the 1996 licensing, the FDA provided a special reference to the application of the VAX-D treatment table by stating the equipment "achieves its effects through decompression." This is the only device in the world that enjoys this distinction. This has now been re-confirmed with the awarding of a patent (No. 6,039,737) from the United States Patent Office on March 21, 2000 for vertebral axial decompression. Unfortunately, the FDA has not created a special category for decompression devices.
There are elements in VAX-D that are common with traction, just as there are elements in common between a CT Scan and X-rays, both of which use ionizing radiation and films to record their images, and although these technologies are classed in the same category, no one would argue that the common elements make these two radiological imaging procedures the same or that the same reimbursement rate should apply to both. It is the complexity of the technology and operational software that makes a CT Scan function differently from an X-ray and with the same logic, makes the VAX-D treatment distinct in performance from traction units.
The term decompression in Stedman's Medical Dictionary states - decompression of a nerve is defined as release of pressure on a nerve trunk. In this context, it is interesting to look up the definition of nerve decompression in the CPT code listing. It states "Neuroplasty (Exploration, Neurolysis or Nerve Decompression) is the decompression or freeing of intact nerve from scar tissue, including external neurolysis and/or transportation." This illustrates that this definition of neuroplasty includes "external neurolysis". It is this pathophysiology associated with discogenic disease that is recognized as the etiology of nerve compression. This of course, is the rationale for surgical decompression of the intervertebral discs. Theoretically, it relieves pressure on the radicular (sciatic) nerve trunks through laminectomy and discectomy. Even percutaneous discectomy and intradiscal electrotherapy (IDET) refer to the procedure as relieving neurocompression, when in fact, there is no evidence whatsoever or even a plausible theory that either of the procedures actually achieve this outcome. VAX-D has proven through published research to achieve decompression and the FDA recognizes that fact.
By comparison, there has never been research indicating traction units can match this vitally important mechanism of action, which is essential in promoting the healing of discs. Traction equipment, used for years, has never proven to exert beneficial effect on the type of difficult cases that are routinely successfully treated with VAX-D and outcome studies continue to confirm the success of VAX-D.
To learn more about Vax-D, go to http://www.vax-d.com.