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Hansen Medical, Inc. (HNSN) Message Board

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  • ooh_the_humanity ooh_the_humanity Jan 7, 2008 2:17 PM Flag

    Safety Tidbits (Natale abstract excerpt)

    Interesting find. I'm no doc, but the page you pointed out also has 2x as many reports on Stereotaxis including one death.

    Scary thing is, in at least one case the giant magnets got in the way from the docs being able to help the patient.

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    • One more point: STXS procedures are now ramping hard and well over 12,000 with no arterial perforations/tears. compare that with the several reported perforations and tamponade events in a tiny fraction of that number of procedures on Sensei gear.

      Like I said, facts are facts.

    • >>> Interesting find. I'm no doc, but the page you pointed out also has 2x as many reports on Stereotaxis including one death. <<<

      you are referring to the march report where the doctor decided to switch to a cryocath cryo-ablation catheter and promptly punctured the heart. as you can see, switching from a soft catheter to a stiff catheter did not help the patient at all.

      • 1 Reply to into_waves
      • humm... a cryocath means stiff? (don't know cryocath - frozen?, but understand stiff verses soft).

        It says he couldn't perform the procedure using the sterioaxis equipment due to its limitations, so needed to try something different to get the job done. If the stereoaxis equipment falls short, won't more doctors start trying reasonable alternatives to get the job done resulting in more injuries and death? He should have been using the Hansen system, since it supports stiff catheters AFAIK.

        The manufacturer's response is confusing: not an invasive product. According to Wikipedia, anything which punctures the skin (soft or stiff) is invasive.

        In fact, all the responses from Stereotaxis for these issues with their products are the same: It is the surgeon's fault. That's very similar to Hansen's response, which you took issue. Are we being a bit hypocritical?

    • If you begin by studying intowaves comments, you are on the path to enlightenment. Next, ask yourself why the arterial perforation events discussed in the initial Morgan Stanley and Jefferies reports issued after the IPO were not reported in the MAUDE register, and note that the HNSN press release file contains another instance of arterial tearing where it was, as per the refrain, "operator error" -- not the fault of the HNSN equipment.

      If sulax didn't get it (he doesn't seem to grasp much except to say HNSN is great), maybe you don't either: the "Natale Adverse Events" per the excerpt above were reported by Natale at the HRS meeting last year. The Deutsche Bank analyst's comment re adverse events and patient injuries were as per his interview of a senior EP doctor at Cleveland Clinic. Comments that have yet to be retorted or refuted in any way. You may also not be aware that despite Moll assertions a few months back (before Natale and others in their EP group left the CClinic) that the ~7 doctor EP group at the CClinic was using the Sensei "pretty much exclusively now," the Deutsche Bank analyst's report makes it crystal clear that just the opposite is the reality: the Cleveland Clinic is now using the STXS gear "pretty much exclusively now" as per the interviewee (a senior EP doctor) remarks.

      If you really want to dig around, do some original work on calls into EP docs and see what you can learn about Sensei and patient outcomes. I have been surprised what can be learned without much effort. On that note, you may also want to consider reading through bh_26's commentary on the STXS board and early on the hnsn board.

      You'll soon have many "interesting finds" of your own to consider. On that note, the abstracts for the Boston Afib symposium will be interesting to study.

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