Tag: Abiomed

Abiomed Receives FDA PMA Approval for Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 […]

National Cardiogenic Shock Initiative (NCSI) with Impella Best Practices Demonstrates 72% Survival with 98% Native Heart Recovery

LAS VEGAS–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) announces that new data from the National Cardiogenic Shock Initiative Study (NCSI) on 171 consecutive AMI cardiogenic shock (AMICS) patients from 35 sites demonstrates 72% survival with 98% native heart recovery at discharge. The patients were treated with the […]

Impella SmartAssist Platform Launches at SCAI, Designed to Further Improve Patient Outcomes

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) announces today that the Impella CP with SmartAssist, which is designed to improve patient outcomes with advanced algorithms and simplified patient management, will be commercially available beginning at the 2019 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific […]

FDA Approves Impella 5.0 and Impella LD Extended Duration of Use to 14 Days for Cardiogenic Shock Derived from AMI or Cardiomyopathy

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) announces the U.S. FDA has approved the expansion of the Impella 5.0 and Impella LD PMA labeling for the treatment of cardiogenic shock. The expansion extends the duration of support for each pump from 6 days to 14 days. The Impella […]