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News Breaks
December 6, 2012
19:02 EDTABMDAbiomed's Impella retains Class III status by the FDA
Abiomed announced that the FDA Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella. The 515i Reclassification Panel's confirmation of this category of device as Class III devices is consistent with both the current Class III classification for these device types and as recommended in the FDA's briefing documents, released on December 3.
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September 16, 2014
17:06 EDTABMDTrial results from Abiomed RECOVER RIGHT show survival rate of 73%
Abiomed announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption study of the Impella RP System. The clinical trial results demonstrated a survival rate of 73% in the overall patient population. Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B had a 58.3% survival rate at 30 days.
September 15, 2014
07:21 EDTABMDHeart Failure Society of America to hold annual meeting
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