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Stereotaxis Inc. Message Board

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  • BuzzyBob BuzzyBob Jan 21, 2011 11:47 AM Flag

    What gives?

    "They should have required their "catheter partners" to put up
    serious money for advertising..... they MUST
    get the patient community on board in order to

    I don't believe they can legally advertise for Atrial Fibrillation, an indication for which they are not yet approved by the FDA. Off label use is okay, just not the promotion of it. I don't understand why Stereotaxis didn't pushed harder on Biosense Webster to pursue approval until the latest royalty agreement.

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    • I hear what you're saying, but this is the
      application that it is being purchased.

      I wonder how many manual ablations are done vs.
      the numbers using mechanical navigation.
      (hnsn or stxs)

      For that matter, I wonder that the numbers
      of procs. look like for stxs vs. hnsn

      That would tell the story AFAIC.

      • 1 Reply to justa_grandpa
      • STXS likely did close to 10,000 procedures in 2010, a number one can derive using the ramping disposables income and mgmt's discussion of the split between service and disposables. The procedural number has been being disclosed only annually (they need to overcome that nonsense), but you'll here it on the cc next month and 10,000 for 2010 is up around 40%+ from 2009 -- about the same as isrg's procedural growth curve for the last 5 years.

        As for HNSN's procedures? From things their paid consultant centers have published and said at the podium, almost no one outside of those 5 centers are doing any Sensei procedures. Off the grid, HNSN no longer matters to STXS for try as they might to put STXS "out of business" as per Fred moll's "quip" three years ago, they have pretty much succeeded only in dismantling their mgmt and sales team, instigating lawsuits, burning $250,000,000 of capital (I'm not making this stuff up funny as it is). Their moribund and dwindling system sales reveal the diminishing interest throughout the EP community.

        btw, AF is progressing well for them, but VT is lighting up the forward path... Niobe is now the "standard of care" for VT ablation therapy... and buzz is correct: they can not promote unapproved procedures without violating FDA regulations.


      Is this the kind of advertising you say they
      can't do?

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