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Abiomed Notes 1st Patients, Including a COVID-19 Patient Are Treated with ECMO Technology

The system can help provide oxygenation to patients suffering from cardiogenic shock or respiratory failure from ARDS, H1N1, SARS, or COVID-19. When used with the Impella heart pump, it can unload the heart and oxygenate the body, a combination therapy known as ECpella.

Abiomed Receives FDA Clearance for the Abiomed Breethe OXY-1 System™

The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end-organ oxygenation. The 510(k) clearance is to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours.

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.”

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.

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.

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 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.

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.