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  • serious_investor serious_investor Dec 23, 1997 12:55 PM Flag

    FDA Clears Palmaz-Schatz(R) Crown Stent

    >Whatta Joke! Crown is still stiff, radioluscent and has virtually no marketshare in Europe. Little or no impact on the Multilink juggernaut. the only positive is the mounting on a high pressure balloon, obviating the need for a post-dil. balloon.<

    Is there a significant cost reduction; i.e., approximately $300 or more, if the need for a post dilatation balloon is eliminated? Will this be the marketing spin for the Crown? If so, why would Cordis be preemptive in reducing the number of balloons per procedure? You'd think that is akin to biting one of the hands that feeds them.

    Also, if the post-dilatation balloon can be eliminated by mounting the stent on a high pressure balloon, has Europe already adopted this technique; i.e., 2 vs. 3 balloons per procedure?

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    • You still need a balloon to predilate to get the stent across the angioplastied lesion. You can use the same balloon to pre and post dil. less of an issue in Europe because one balloon is used to predil., stent is hand crimped on and then post dilated. In US stents are already crimped on a delivery balloon.

      • 1 Reply to stentemall
      • Tuesday December 23, 3:47 pm Eastern Time

        Company Press Release

        SOURCE: Arterial Vascular Engineering, Inc.

        AVE Receives FDA Approval to Market Coronary Stents

        SANTA ROSA, Calif., Dec. 23 /PRNewswire/ -- Arterial Vascular Engineering, Inc. (``AVE'') (Nasdaq: AVEI - news) today announced that it had received
        premarket approval (``PMA'') from the U.S. Food and Drug Administration (``FDA'') to begin immediate commercialization of its Micro Stent(R) II and GFX(TM)
        coronary stent systems in the United States. The PMA covers the broadest range of coronary stent sizes ever approved by the U.S. FDA under a single PMA
        application, including diameters of 3.0mm, 3.5mm and 4.0mm and lengths of 6mm, 9mm, 12mm, 15mm, 18mm, 24mm, and 30mm for the Micro Stent(R) II and
        diameters of 3.0mm, 3.5mm and 4.0mm and lengths of 8mm, 12mm, 18mm, 24mm, and 30mm for the GFX(TM) stent. The FDA approval was granted just 140
        days following AVE's electronic filing of its PMA application in August.

        etc etc