FDA Approves Abiomed's Impella Therapy for Cardiogenic Shock After Heart Attack or Heart Surgery

April 7, 2016—Abiomed, Inc. announced that it has received 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 of ongoing cardiogenic shock. In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs, and allow for the recovery of the native heart. This latest approval adds to the previous FDA indication of the Impella 2.5 for high-risk percutaneous coronary intervention (PCI), or Protected PCI, received in March 2015.

According to the company, the FDA approval certifies that these percutaneous temporary ventricular support devices are safe and effective for the cardiogenic shock indication. The Impella 2.5, Impella CP, Impella 5.0, and Impella LD catheters, in conjunction with the automated Impella controller console, are 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) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) after acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump.  

The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. The product labeling also allows for the clinical decision to leave the Impella 2.5, Impella CP, Impella 5.0, and Impella LD in place beyond the intended duration of 4 to 6 days if needed because of unforeseen circumstances.

Abiomed stated that the Impella devices both stabilize the patient’s hemodynamics before or during a PCI procedure and unload the heart, which allows the muscle to rest and potentially recover its native function. 

In the company’s press release, William O’Neill, MD, commented, “This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high-mortality risk. The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function." Dr. O’Neill is Medical Director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Michigan.