Abiomed Completes All Impella Postapproval Studies for High-Risk PCI, Cardiogenic Shock, Postcardiotomy Cardiogenic Shock, and Right Heart Failure

October 20, 2022—Abiomed announced that the FDA has accepted and closed the postapproval study reports related to the premarket approvals (PMAs) for the company’s Impella heart pumps.

In total, Abiomed completed five postapproval studies for Impella during the 7 years since its initial PMA was received. This multicenter experience was conducted at 46 sites and enrolled a total of 1,833 patients.

According to Abiomed, the FDA’s action is an additional affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk percutaneous coronary intervention (PCI), postcardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.

The totality of Impella data collected in the United States, Europe, and Japan demonstrates that Impella improves outcomes and lowers costs.

As outlined by the company, the data from various published studies showed the following:

• 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.
• 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 study, and up to two times higher survival for extracorporeal membrane oxygenation therapy when combined with Impella unloading (known as ECpella).
• Impella is a cost-effective therapy that reduces hospital length-of-stay by 2 to 11 days in elective, urgent, and emergent settings; reduces hospital cost per case by $45,000 to $54,000 in coronary artery disease and acute myocardial infarction (AMI) cardiogenic shock; and provides up to $887,000 in cost savings for each avoidance of a heart transplant or implantable left ventricular assist device (LVAD).

Abiomed noted that the Impella heart pump has been studied since 2006. Real-world data exist on approximately 200,000 Impella patients. Impella is the subject of > 1,200 peer-reviewed publications. It is included in 13 clinical society guidelines.

The clinical data and best practices learned from all Impella studies performed with the FDA, the Japanese Pharmaceuticals and Medical Devices Agency, and in Europe, combined with prospective and real-world data, informed the design of the ongoing PROTECT IV and RECOVER IV randomized controlled trials. These on-label trials are designed to achieve the level of evidence for Impella to receive class I guideline recommendations for high-risk PCI and AMI cardiogenic shock, noted the company.

The company noted that Impella CP with SmartAssist is FDA approved to treat certain advanced heart failure patients undergoing elective and urgent PCI. Impella CP with SmartAssist and Impella 5.5 with SmartAssist are FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and enable native heart recovery. Impella RP with SmartAssist is FDA approved to treat right heart failure or decompensation after LVAD implantation, myocardial infarction, heart transplant, or open heart surgery.