Shares of Abiomed (ABMD) remain halted as the FDA's 2-day advisory committee meeting over...


Shares of Abiomed (ABMD) remain halted as the FDA's 2-day advisory committee meeting over nonroller-type cardiopulmonary bypass blood pumps proceeds. In briefing documents, the FDA said that there was a lack of valid scientific evidence to support the safety and effectiveness of non-roller type blood pumps during high risk interventional or surgical procedures. ABMD markets its own cardiopulmonary bypass blood pump, the Impella 2.5, and should the committee decide to not down-classify the device, ABMD may be required to file a pre-market approval application requiring it to initiate additional clinical trials.

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Comments (2)
  • philipzimmerman
    , contributor
    Comments (2) | Send Message
     
    I hope that Hilary Kramer was correct in relying on this device obtaining FDA approval now.
    6 Dec 2012, 02:14 PM Reply Like
  • Sundance18
    , contributor
    Comment (1) | Send Message
     
    Why should this pump's complication profile be any different during cardiac procedures than during heart failure? This objection makes no sense...
    6 Dec 2012, 02:14 PM Reply Like
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