Tag: Impella

First Patient Enrolls in STEMI DTU Randomized Controlled FDA Trial; Study Aims to Further Demonstrate Impella’s Safety and Effectiveness

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will […]

Clinical Review Demonstrates Cost-Effectiveness of Impella in High-Risk PCI and Cardiogenic Shock

DANVERS, Mass.–(BUSINESS WIRE)–To mark the five year anniversary of the study by Stretch, et al., on cost and outcomes trends for short-term mechanical circulatory support, Abiomed announces a comprehensive publication review of cost and comparative effectiveness of Impella in high-risk PCI and cardiogenic shock. […]

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 […]

Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases Cardiogenic Shock Survival

SAN DIEGO, Sept. 24, 2018 (GLOBE NEWSWIRE) — A new analysis of data from Abiomed’s (NASDAQ:ABMD) Impella® Quality (IQ) Database shows a relative increase of 24% in mean survival in acute myocardial infarction (AMI) cardiogenic shock patients since Impella’s cardiogenic shock FDA post-market […]