Abiomed
FDA EUA Issued for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients
“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” said Christian Bermudez, MD, surgical director, lung transplantation and ECMO, and professor of surgery at the University of Pennsylvania. “The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”
Abiomed
Impella Heart Pump Large Multi-Center Study in Japan Update
The study, conducted with oversight by 10 Japanese professional societies, including the Japanese Circulation Society (JCS), is the first to use the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) to investigate the efficacy and safety of Impella.
Abiomed
Impella RP as Therapy for COVID-19 Patients with Right Heart Failure Receives FDA EUA
Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure.
Abiomed
PROTECT III Study Shows Placing Impella Prior to High-Risk PCI is Associated with Lower Mortality Compared to Bailout PCI
The data presented is from an adjunct study of PROTECT III, the ongoing, prospective FDA post-approval study for Impella in high-risk PCI.
Abiomed
Abiomed Announces a Comprehensive Publication Review of Cost and Comparative Effectiveness of Impella in High-Risk PCI and Cardiogenic Shock
The data, from a robust body of US and European evidence from 2004 - 2019, includes the PROTECT II FDA randomized controlled trial, data from the Centers for Medicare & Medicaid Services MedPAR database and more than 20 peer-reviewed clinical publications on cost-effectiveness.
Abiomed
Impella RP Post-Approval Study Data Presented at ACC 2019
3/18/19: The Impella RP is the only percutaneous technology with FDA PMA approval for right heart support designated safe and effective. The table below summarizes the new post-approval study data and compares it to the FDA study results submitted for Impella RP’s PMA approval.
Abiomed
Abiomed Invests $100 Million Plus Over the Past Five Years in Clinical Research on the Impella Heart Pump Platform
2/25/19: Abiomed launched a new webpage today that shows their commitment to clinical research regarding the Impella Heart Pump Platform.
Abiomed
FDA Safety Study of Unloading the Left Ventricle for 30 Minutes Prior to Reperfusion in Heart Attack Patients is Safe and Feasible
11/12/18: 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 cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately.
