Abiomed's Impella Devices Receive Expanded Indication for Cardiomyopathy With Cardiogenic Shock
February 13, 2018—Abiomed, Inc. announced that it has received an expanded US Food and Drug Administration (FDA) premarket approval for its Impella 2.5, Impella CP, Impella 5.0, and Impella LD heart pumps to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock.
This approval expands the previous FDA indication for acute myocardial infarction cardiogenic shock and postcardiotomy cardiogenic shock, which the Impella devices received in April 2016.
In a press release, the company explained that the data submitted in support of this expanded approval included an analysis of 93 patients from Abiomed's FDA-reviewed cVAD Registry study, as well as a comprehensive literature review including 109 patients treated with Impella from 32 clinical publications. These data reinforce previous FDA studies that demonstrated the safety and effectiveness of Impella support in elective and emergent patient populations.
According to Abiomed, the Impella heart pumps are the only percutaneous temporary ventricular support devices that are FDA approved as safe and effective for cardiogenic shock in the setting of cardiomyopathy. Specifically, the Impella devices, in conjunction with the automated Impella controller, are temporary ventricular support devices intended for short-term use (≤ 4 days for the Impella 2.5 and Impella CP and ≤ 6 days for the Impella 5.0 and Impella LD).
All four devices are indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery, or in the setting of cardiomyopathy or myocarditis as a result of an isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.
A postapproval study of cardiomyopathy patients will be conducted for 5 years using the cVAD Registry study, stated Abiomed.