Impella heart pumps have been developed and produced for more than 20 years to stabilize and recover the human heart. The single access procedure enables the treating physician not only to place Impella heart pumps in the ventricle via the 14 French Impella CP introducer sheaths, but also to insert other catheters and introducer sheaths. Thus, cardiac interventions such as percutaneous coronary interventions can also be performed via the 14 French Impella CP introducer sheaths.
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.
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.
“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.”
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 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.
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