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December 3, 2012
14:43 EDTABMDAbiomed may have to obtain stringent approval for Impella, says Piper
Piper Jaffray predicts that Abiomed could be forced to obtain a PMA, or pre-market approval, for its Impella device. Pre-market approvals are the most stringent type of device marketing application required by the FDA, according to the agency's website. The firm thinks the company will have to conduct a series of new studies, but it maintains an Overweight rating on the stock, citing valuation. However, the firm expects the shares to remain range-bound in the near-term.
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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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