FDA approves expanded use of Impella 2.5, Impella CP heart pumps for elective and urgent high risk percutaneous coronary intervention.- Abiomed.

Abiomed announced that it has received an expanded 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. This expanded indication confirms Impella support as appropriate in patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction (EF).

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).

With this expanded approval, the FDA has further validated this �first of its kind� indication for High Risk PCI and the benefit of percutaneous hemodynamic support in treating severely complex patients with mild, moderate and severely depressed ejection fraction. Clinical society guidelines from the ACC/HFSA/SCAI/STS consensus publication support the use of Impella in patients with reduced or normal left ventricular function and severe coronary artery disease for treatment of anticipated technically challenging or prolonged PCI patients.