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In December 2016, the premarket approval was expanded to include the Impella CP heart pump. [24] In April 2009, the Impella 5.0 and Impella LD heart pumps received 510(k) clearance for circulatory support for periods of up to six hours during cardiac procedures not requiring cardiopulmonary bypass. [25]
In 2005, Abiomed purchased ventricular assist device company Impella CardioSystems AG of Aachen, Germany, [11] maker of the Impella heart pump, developed by Thorsten Siess, [12] who is now the chief technology officer at Abiomed. [13] [self-published source] After Abiomed acquired Impella the company's focus shifted from heart replacement to ...
[13] [14] [15] In some pulsatile pumps (that use compressed air as an energy source [16]), the volume occupied by blood varies during the pumping cycle. If the pump is contained inside the body then a vent tube to the outside air is required. Continuous-flow VADs are smaller and have proven to be more durable than pulsatile VADs. [17]
There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump’s ...
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The HeartAssist5 is a modern version of the DeBakey VAD [10] and as of December 2014 was the only remotely monitored medical device in the world. [8] It was first approved for use in Europe in 2009 under MicroMed Cardiovascular, Inc. [11] The HeartAssist5 is in use in Europe [10] as a destination therapy by patients who are not candidates to receive heart transplants and as a bridge to ...
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