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Monday, March 10, 2008

TETRA-NIRS Bladder Monitor Approved

Filed under: Urology

The FDA just granted approval for marketing the TETRA™-NIRS, a non-invasive urodynamics device from Urodynamix, of Vancouver, Canada. The device uses near infrared spectroscopy (NIRS) to penetrate with light through the skin and into the bladder, and determine how full it is in real time. According to the press release, the device is designed to help to analyze bladder outlet obstruction as well as bladder activity not readily available on simple uroflowmetry. Here are the basic details from the company on its technology:

  • NIRS emitter projects near infrared light through the skin, illuminating the detrusor muscle of the bladder.

  • Some of the light is absorbed by chromophores in the tissue (e.g. oxygenated and deoxygenated hemoglobin and cytochromes) and some is scattered, with a small amount returning to a light detector.

  • Bladder function is evaluated by continuously monitoring the concentrations of chromophores in the detrusor muscle during voiding.

    • Press release: Laborie Medical Technologies Receives FDA Pre-Market Clearance for TETRA(TM)- NIRS Accessory for the US Market

    Urodynamix technology page...

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    replies: 1 comments
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    I don't buy it... I spent a couple of years in a lab working on NIRS measuring skeletal muscle (at the same med school as Dr. Genes - in fact, we overlapped by a year or two) and it was phenomenally hard to get any sort of *quantitative* data. Sure, you can see a change in the spectrum that says "yep, there's muscle work happening" (in my lab's case, flexor digitorum profundus in the forearm; in this case the bladder detrusor) based on deoxygenation........but differentiating 10% change vs 90% change was rather, um, "tricky" (i.e. we never did get it to work reliably by the time that I left, and last I heard they still hadn't). If they're getting the same kind of only-very-quasi-quantitative data from this bladder monitor, you could get just as good monitoring from putting a liquid sensor in the patient's diaper! I won't even get in to the issue of overlying muscle tissue that *just might* interfere -- we had trouble with the FDP at a point where it was just under the skin, and I can't imagine that they can differentiate the bladder detrusor from the abdominal musculature!

    The complete and utter lack of citations on their "tech" page (or anywhere else on their website) seemed a little fishy, too...

    Just my two cents.

    Mike


    Posted by: Mike
    on March 10, 2008 04:49 PM GMT

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