Abiomed Receives Approval for Expanded FDA Indication

Abiomed (Nasdaq:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced that it has received an expanded U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for the Impella 2.5^® and Impella CP^® heart pumps during elective and urgent high risk percutaneous coronary intervention (PCI) procedures.

As quoted in the press release:

Impella’s initial approval for High Risk PCI was based on two FDA studies (PROTECT I and PROTECT II), that treated the sickest and most severe patients in the catheterization lab with the majority being denied open heart surgery. This change broadens the appropriate use of Impella support and eliminates the requirement for depressed ejection fraction in the presence of severe coronary artery disease or complex anatomy (e.g., left main, multi-vessel, or requiring rotational atherectomy).

Click here to read the full press release.