CE Mark for aVAD intraventricular heart pump from ReliantHeart Inc.
ReliantHeart Inc. has announced that its aVAD intraventricular heart pump (left ventricular assist device) won CE Mark approval in the European Union, allowing the company to begin implants in the coming months. The device, while only 2.5 centimeters in diameter, still has a 1.2 cm main channel for the blood to flow through. It rests outside the ventricle, while a component that is inserted into the heart contains an adjustable pump depth mechanism to provide optimal action for individual patients.
Comment: The pump is actually modeled on the already approved HeartAssist 5 device, having exactly the same blood path, but offering more power. This led to a quick approval by the European authorities and ReliantHeart hopes human trials to begin in the U.S. next year.The pump is already being manufactured with initial implantations to begin as early as September in Germany, Turkey, and U.K.
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