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June 3, 2014
08:12 EDTABMDAbiomed surpasses 20,000 U.S. Impella patients
Abiomed reported that physicians have implanted more than 20,000 Impella pumps in U.S. patients requiring hemodynamic support. To date, the higher flow Impella CP has been implanted in over 3,000 U.S. patients, the company noted. The Impella RP recently received CE Marking approval in the European Union and also completed patient enrollment in its Investigational Device Exemption trial, RECOVER RIGHT, with an extended Continuous Access Protocol to allow the company to continue enrolling an additional 22 patients into the trial for further evaluation. FDA approval for the Impella RP is expected by early 2015, Abiomed said.
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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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