Tag: Abiomed

FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI […]

Cardiogenic Shock Survival Rates Improve Significantly in Three Years Since Impella FDA PMA Approval

DANVERS, Mass.–(BUSINESS WIRE)–Three years ago this week, Abiomed’s (NASDAQ: ABMD) Impella heart pumpreceived its FDA PMA approval for AMI cardiogenic shock. At the time of Impella’s FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance (IQ) Database was […]

FDA Safety Study of Unloading the Left Ventricle for 30 Minutes Prior to Reperfusion in Heart Attack Patients is Safe and Feasible

CHICAGO–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP® for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without […]