Abiomed successfully completes all Impella post-approval studies for high-risk PCI, cardiogenic shock, post-cardiotomy cardiogenic shock and right heart failure.

The FDA’s action is another affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.

The FDA typically requires post-approval studies for medical devices that receive a PMA, the FDA’s highest level of regulatory approval. FDA post-approval studies use high-quality prospective data to confirm that the clinical study data submitted to the FDA to receive a PMA applies to a broader, real-world population of patients.

In total, Abiomed completed five post-approval studies for Impella over the seven years since its initial PMA was received. This large, multi-center experience was conducted at 46 sites and enrolled a total of 1,833 patients.

This data includes: i. Impella-supported Protected PCI improves quality of life, with a 22% to 45% improvement in left ventricular ejection fraction at 90-day follow up, a 58% to 80% reduction in New York Heart Association Class III and IV symptoms, and 29% to 47% fewer adverse events at 90 days. ii. Impella improves outcomes in cardiogenic shock, with 71% to 82% survival with best practice protocols 90% to 99% native heart recovery in the 2018 to 2020 National Cardiogenic Shock Initiative (NCSI) Study and up to two-times higher survival for ECMO therapy when it is combined with Impella unloading (known as ECpella). iii. Impella is a cost-effective therapy that reduces hospital length-of-stay two to eleven days in elective, urgent and emergent settings, reduces hospital cost per case by $45,000 to $54,000 in coronary artery disease and AMI cardiogenic shock and provides up to $887,000 in cost savings for each avoidance of a heart transplant or implantable LVAD. Impella is the most studied heart pump in the history of the FDA, with studies being conducted from 2006 to the present.

ABOUT IMPELLA HEART PUMPS: i. Impella CP with SmartAssist is FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries. ii. Impella CP with SmartAssis® and Impella 5.5 with SmartAssist are FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. iii. Impella RP with SmartAssist is FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.