Abiomed received the European CE Mark to make available its Impella cVAD heart pump on the continent.
The device looks and behaves just like the popular Impella 2.5 pump, but is more powerful with a maximum blood flow of 4 liters per minute versus 2.5 for its sibling. And just like the Impella 2.5, the Impella cVAD is percutaneously implanted via a 9 French catheter into the left ventricle, and is powered by the same proven console.
From the announcement:
According to the labeling under CE Mark in Europe and other countries, the Impella cVAD (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and cardiac surgery for up to 5 days for the following indications, as well as others: the Impella cVAD is a circulatory support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction; the Impella cVAD may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome; support during high risk percutaneous coronary intervention (PCI); post PCI.
Press release: Abiomed Receives CE Mark for Impella cVAD…
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