In a letter to healthcare providers, the US FDA summarized a recent evaluation of a postapproval study of the Abiomed Impella RP system. In clinical trials, 73% of patients survived 30 days after device explant, hospital discharge, or to definitive intervention. In the postapproval study, just over 17% of patients met this goal. There is some evidence to suggest that patients in the postapproval study were suboptimal candidates for the system.
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Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System
Submitted by: Mark Ferguson
Source: US Food and Drug Administration
Keywords:
Author(s): US FDA
