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