The US Food and Drug Administration (FDA) has granted two approvals related to the clinical research of Abiomed’s Impella heart pumps.
The regulator has approved the on-label RECOVER IV randomised controlled trial (RCT) of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.
Abiomed noted that the two-arm study protocol received FDA approval to use the Exception from Informed Consent (EFIC) pathway for subject enrolment.
It will evaluate whether Impella support initiated before percutaneous coronary intervention (PCI) is superior to PCI without Impella.
All-cause mortality at 30 days will be the study’s primary endpoint.
Major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, left ventricular function recovery, days alive after hospital discharge at six months, and need for durable ventricular assist device (VAD) or heart transplant will be some of the secondary endpoints of the study.
The health-related quality of life at one year will also be measured by responses to the Kansas City Cardiomyopathy Questionnaire as the study’s secondary endpoint.
The company’s aim to conduct the RECOVER IV trial is to achieve a global AMI cardiogenic shock Class I guideline recommendation for Impella.
It also aims related best practice protocols, such as Impella implantation pre-PCI.
Tufts Medical Center Cardiovascular Center for Research and Innovation (CVCRI) executive director and RECOVER IV national co-principal investigator Navin Kapur said: “I am optimistic that RECOVER IV will further demonstrate the benefits of hemodynamic support and best practice protocols.
“These benefits include ventricular unloading using Impella pre-PCI, reduced LV wall stress, reduced pulmonary congestion, increased collateral coronary blood flow, and enhanced cardio protection so that more AMI cardiogenic shock patients can survive and achieve native heart recovery.”
The FDA has also approved and closed RECOVER III post-approval study (PAS) of Impella to treat AMI cardiogenic shock.
This study has collected the real-world data on AMI cardiogenic shock patients who are treated with Impella between 2017 and 2019.
The detailed data includes cardiogenic shock stages, cardiac output, and implantation timing.
Abiomed stated that the regulatory approval and closure of the trial further validates the heart pump as a safe and effective therapy for AMI cardiogenic shock.