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Examples
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Also, Abiomed has to prove to cardiologists that Impella provides a clinical advantage versus intraaortic balloon pumps
Medgadget 2009
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This is achieved by intraaortic balloon pumps and Impella.
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We also believe more patients will benefit from Impella as compared to an intraaortic balloon pump due to the science of how Impella works.
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Because these trial patients are very sick, we have had a few centers that have dropped out of Protect2 or will be dropping out because they feel uncomfortable randomizing to an intraaortic balloon pump now that Impella is commercially available and they feel Impella is more effective for their patients.
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From a practical perspective, they already know after one usage that Impella actively pumps approximately 5 times more blood than an intraaortic balloon pump.
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This signifies that the intraaortic balloon pump or IABP conversion to Impella is happening under the 510 (k) clearance.
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