Errata sheet regarding the publication “The Impella device questioned in the post-approval studies due to an increase of adverse events”

What was published in our website refers to the original publication by the FDA (Increased rate of mortality in patients receiving Abiomed Impella RP System – letter to health care providers) where, inadvertently, it was excluded from the title that the FDA communication referred exclusively to the Impella RP device.

The Impella circulatory assistance system comprises 4 different devices:

. Impella CP (the only model approved to be used in a LATAM country as Brazil).

. Impella 2.5 and Impella 5.0: for left ventricular assistance.

. Impella RP: for right ventricular assistance. It is this device in particular that the aforementioned published article refers to. This article is nothing but a summary of the FDA communication.

The lack of specification of the acronym RP in the title, referring to this particular model, could lead doctors reading only the title of the article to generalize these results to the rest of devices. This would, without a doubt, jeopardize left assistance models that have proven their benefits in the context of complex angioplasties and cardiogenic shock. By reading the full text of the article it is clear to which model it is referring to, but this is not so in the title, reason for which we believe it’s convenient to publish the present errata sheet.

Soon, we will publish a recent analysis of over 15,000 patients in the US that have benefitted from left assistance.