Abiomed has received two FDA clearances for clinical studies using Impella cardiac pumps in patients with acute myocardial infarction (AMI) cardiogenic shock.
The FDA has approved the on-label RECOVER IV randomised controlled trial (RCT) for AMI cardiogenic shock patients.
RECOVER IV is a two-arm study intended to determine the effectiveness of percutaneous coronary intervention (PCI) with Impella support started prior to the PCI compared to PCI without Impella support.
The medical device company said that the primary endpoint of the RECOVER IV trial is all-cause mortality at 30 days.
The secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, days alive out of the hospital at six months, recovery of left ventricular (LV) function, need for a durable ventricular assist device (VAD), or heart transplant.
Abiomed stated that the Kansas City Cardiomyopathy Questionnaire (KCCQ) responses at one year are also used to assess health-related quality of life.
The company intends to attain a global AMI cardiogenic shock Class I guideline recommendation for Impella and related best practice protocols, including Impella implantation pre-PCI.
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 heart team and field have evolved and understand how important myocardial recovery is for both AMI and AMI cardiogenic shock to reduce the growing epidemic of heart failure.”
Furthermore, the health regulator has authorised and completed Impella’s RECOVER III prospective AMI cardiogenic shock post-approval study (PAS).
RECOVER III collected real-world data, including the phases of cardiogenic shock, cardiac output, and timing of implantation, on AMI cardiogenic shock patients treated with Impella between 2017 and 2019.
According to the firm, the FDA’s clearance and closing of RECOVER III further support Impella as a safe and effective treatment for AMI cardiogenic shock, and RECOVER III satisfies Abiomed’s PAS requirement.
