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Medical device licence pulled, but still on the market
By Marketplace Staff
Tuesday, June 15, 2010, 3:26 PM
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You might think when a license for a medical device gets pulled by health officials, that you're protected -- and that device can no longer be used in Canada. 

Well, an investigation by Marketplace has discovered that's often not the case.

Earlier this year, we investigated the DRX-9000, a "non-surgical spinal decompression therapy device" used to treat back pain. Consumers paid about $4,000 for 20 treatments to lay on this high-tech bed. The manufacturer, Axiom Worldwide, claimed it had an 86 per cent success rate.

It was a claim we found was based on junk science. "I'm not convinced this has any scientific basis," said Dr. Hamilton Hall, an orthopedic surgeon and back specialist, in our March report Stretching the Truth?. "There is nothing you have shown me on the web, in the articles you've presented, nothing that offers scientific support."

After our story, Health Canada revoked the mandatory license for the DRX-9000, saying the manufacturer  "did not respond to Health Canada's request for evidence to support the success rate of pain reduction."

But even though the company can no longer sell the device in Canada, the doctors and chiropractors (and anyone else who bought the DRX-9000) can keep using it.

Marketplace also discovered that some who have the table are still touting a high success rate. Using a hidden camera, we visited a Toronto-area back clinic and one chiropractor said the device has a "90 per cent success rate."

So even though Health Canada has suspended the DRX-9000's medical licence, it's up to the manufacturer to notify its customers that the machine's license has been pulled.

However, the manufacturer is based in Florida, and is insolvent. So people go on using the machine and keep making the unproven claims. 

Essentially, nothing's changed.
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