fuel for algos

[drrinoo]

Came across your comments on FDA regulation of pain devices vis a vis the ISIS forum...your comments are prescient...

the FDA has delayed approval of the vagal nerve stimulator for depression, due to lack of sufficient data, ie., RCTs..., note that they did not delay approval based on safety data alone, but rather, lack of clinical outcomes data...the sad part is that the VNS probably works in those patients who have exhausted all other treatments and it is a pretty easy and safe procedure for a neurosurgeon....go figure

I don't understand how most of our interventional pain devices escaped the FDA clinical data radar?

IDET was FDA approved even before there was significant peer reviewed published (not abstracts) animal/cadaver data and human clinical data...then again, most of the devices in pain use existing technologies and may be they are getting away with investigational device exemptions?

Any thoughts?

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[Aether2000]

I have queried the FDA about this and was told the 5 divisions of the FDA have no common responsibility to demonstrate safety and efficacy as is the case with biologics and pharmaceuticals. Each division is run separate from the other divisions.
Some of the technologies, such as IDET were approved by the FDA on the basis of 20 patients with short term outcome studies. The fact that they did not die from the trial was apparently sufficient reason for the FDA to approve the procedure. Their own literature states there must be studies demonstrating the usefulness of the procedure which cannot be internal trials. So they are asleep at the switch with respect to device regulation. Pulsed RF had no clinical studies presented...it was just an idea that suddenly was tacked onto the machines of all 6 manufacturers selling the RF machines in the US. Nucleoplasty was apparently approved due to being kind of sort of like IDET. No clinical studies. Distrode the same. Dekompressor the same. Interestingly Laser disc decompression has a long history with many clinical studies...