Tag: Abiomed

FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™. The ECMO system provides cardiopulmonary bypass support for patients whose lungs can […]

Data Presented at TCT Connect Finds Pre-PCI Use of Impella for AMI Cardiogenic Shock is Associated with Higher Survival, Particularly in Women

DANVERS, Mass.–(BUSINESS WIRE)–Two studies of AMI cardiogenic shock (AMICS) patients found higher survival when Impella was placed pre-PCI, compared to when Impella was placed after PCI. The findings were presented at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular […]

Largest Study of Hemodynamically Supported High-Risk PCI Patients Finds More Complete Revascularization with Impella Leads to Improved Outcomes

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces new PROTECT III study data that demonstrates reduced rates of MACCE (composite of death, stroke, myocardial infarction and repeat procedures) when Impella is used to achieve a more complete revascularization in a single setting for high-risk percutaneous […]

Restore EF Study Demonstrates Impella-Supported High-Risk PCI Improves Left Ventricular Ejection Fraction

DANVERS, Mass.–(BUSINESS WIRE)–The Restore EF Study demonstrates the use of contemporary best practices, including attempting a more complete revascularization with Impella-supported high-risk PCI, is associated with significant improvement of left ventricular ejection fraction (LVEF), heart failure symptoms, and anginal symptoms at […]

TCT Connect to Highlight How Impella Enables Improved Outcomes for High-Risk PCI, Cardiogenic Shock and Right Heart Failure Patients

DANVERS, Mass.–(BUSINESS WIRE)–The benefits of a more complete revascularization with Impella heart pumps in high-risk percutaneous coronary intervention (PCI) patients and the value of Impella protocol-based treatment for survival and native heart recovery in cardiogenic shock patients will be highlighted at TCT Connect, […]