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Hansen Medical, Inc. (HNSN) Message Board

  • sirdrsardonicus sirdrsardonicus Jan 2, 2008 1:19 PM Flag

    Safety Tidbits (Natale abstract excerpt)

    Assuredly most of the HNSN longs have extensively reviewed the safety record of HNSN, however, some of the newbies here might enjoy a little head start on finding the not so readily available HNSN safety record/clinical data published to date. Beyond this head start, other things perhaps worth studying include the HNSN SEC file (e.g., the FDA submission/dialogue recap); the press release re ~"the physicians fault, not the equipment" re arterial tearing); the jpmorgan and jefferies reports discussing the "aterial perforations" back after the IPO quiet periods; HRS abstracts documenting confusion over how much force to apply; the technical paper published by rojit on yahoo and google (STXS boards) and fred moll's comments re "~our safety record is just as good as manual" [which is way back from STXS' vastly superior record on well over 12k procedures through 9/30/07].

    BTW, you may want to google a bit on Dr. Andrea Natale and his involvement with HNSN, particularly in Czech outings (see below in his own words), and while at the Cleveland Clinic (which recently terminated him). On that note, you may want to also read the DBAB/Alex Brown analyst's published report re HNSN's safety issues. It is also available for a little work on the STXS board.

    Have fun, and good luck with those sexy HNSN shares.
    >>


    HNSN Safety Record

    Natale�s Czech Experience
    >>
    HNSN hasn't made it easy to uncover all the different pieces related to procedure outcomes and complications. it's like an easter egg hunt. there is some info in the 10K. below is one of the puzzle pieces. google "cardiac tamponade" under the Cedar Sinai site if you don't know what that means.

    >>>>
    from [last] year's ACC an excerpt from Natale et al's paper re ablations done in Czech:

    "PVAI was performed in 30 patients, including 14 with concomitant atrial flutter ablation. All PVs including the SVC were successfully isolated. In nine patients, atrial flutter was mapped and ablated with bidirectional block obtained. Two patients developed pericardial tamponade requiring pericardiocentesis with no other sequelae (procedure aborted in one patient). At 90 days follow-up, 26 patients and 5 patients were free from atrial arrhythmia off AAD and on AAD, respectively. Two patients developed recurrent atrial arrhythmia; one AF patient required another procedure for atrial flutter; three patients were lost to follow-up."
    <<<<


    Maude Database
    Link:
    >>
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=952110
    <<

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    • stock_baron,

      here is the "head start" on clinical data you asked for... note that the dbags here have nothing to say except to engage personal attacks on anyone who says anything less than rosy about HNSN.

      do note the stock had retreated from $40 to $30 when the street started to figure out the moll/Cramer hype machine had some broken teeth in the gears.

    • I can't wait to see the bevy of clinical data from STXS and, I suspect, the complete lack of clinical data from Hansen.

      Maybe HNSN will help their pocket affiliates using Sensei given to them at <15% margins with special training re precedures to deal with "expected" tamponade/arterial piercing in the form of recovery procedures.

    • HM;
      Please get a job and stop spewing this garbage. You are a bitter long STXS wannabe/employee who is trying to will STXS above $11.
      Your facts are all wrong and grossly biased. You are offerring zero value to anyone wanting objective info/advise on the remote navigation space.
      By the way, why don't you call Natale yourself and ask him about his experience instead of offerring/relying on DB biased hearsay. You are a clown....

      • 1 Reply to sulax00
      • sulax,
        stxs wannabe? golly, you are special. It is hard to imagine, but with each passing post you make it evermore clear how ignorant and doltish you are...

        As to "facts": facts are facts. You might want to compare the definition of that with "opinion" and your "drivel." The subject comments were not the Deutsche Bank analyst's comments... they were those of none other than Natale and his associates and based upon their let's call it incredibly revealing and dismal results in Czech. Did that make it through your retarded processing?

        As to "grossly biased"... I have probably been the most critical poster on the yahoo STXS board since November, and over the last three years, I can think of only one other poster who has shared a comparable volume of studied, critical commentary re mgmt of STXS. Are you retarded?

        As to adding value or presenting things such that those reading at a 5th grade level understand them? That is not an objective.

        As to Deutsche Bank "hearsay"... ahem... has the Cleveland Clinic or HNSN retorted the "facts" and interviewee comments discussed in the subject report? Call investor relations and see what you can learn about that.

    • 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.

      • 3 Replies to ooh_the_humanity
      • 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.

      • 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 investorvillage.com 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.

      • >>> 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.

    • This was relevant on this topic.

 
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