These things always take patience. I don't believe we know how many institutions have finished with their internal reviews of the study and have the legalese sorted so they can actually start implanting patients. The EFS could be completed in time for TCT late next month but if it isn't, there will still be more than enough data to present.
And get ready to hurry up and wait with the 900-1000 patient pivotal trial that will commence next year. That trial will likely take 18 months to 2 years to enroll and will require boatloads of patience along the way.
Something I hadn't realized until reading transcripts of Edwards last quarterly call from late July is that earlier this year they suspended enrollment of the 915 patient pivotal trial for their next generation Sapien X4 due to an issue or change with the delivery system. That was a huge setback. They had to start all over again with participating hospitals needing to do new reviews of the trial before they could restart enrollment.
AVR Price at posting:
$21.05 Sentiment: Hold Disclosure: Held
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