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The FDA has approved the on-label Recover IV randomized controlled trial involving acute myocardial infarction (AMI) cardiogenic shock patients. The two-arm trial will assess whether Impella support before percutaneous coronary intervention is superior to PCI without Impella.

Often caused by a severe heart attack, cardiogenic shock involves the heart suddenly being unable to pump enough blood to meet the body’s needs, according to a Mayo Clinic description. Presently, only about half of the people with cardiogenic shock survive post-treatment. Abiomed says that multiple Impella best practice studies demonstrate greater than 70% survival —plus greater than 90% 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,” said Dr. Navin Kapur, executive director of the Cardiovascular Center for Research and Innovation (CVCRI) at Tufts Medical Center and a national co-principal investigator for Recover IV.

Kapur added in the news release: “I am optimistic that Recover IV will further demonstrate the benefits of hemodynamic support and best practice protocols.”

The primary endpoint of Recover IV is all-cause mortality at 30 days. The study also includes secondary endpoints: major adverse cardiovascular and cerebrovascular events at 30 days, days alive out of the hospital at six months, recovery of left ventricular function, and the need for a VAD or heart transplant. It will also track the health-related quality of life at one year using the Kansas City Cardiomyopathy Questionnaire.

Abiomed said Recover IV’s goal is to achieve a global AMI cardiogenic shock Class I guideline recommendation for Impella. Additionally, it wants related best practice protocols, including Impella implantation pre-PCI.

Abiomed also announced that the FDA has approved and closed the Recover III post-approval study of Impella use to treat AMI cardiogenic shock The study collected real-world data on AMI cardiogenic shock patients treated with Impella between 2017  and 2019. Abiomed said Recover III provided further validation of Impella as a safe and effective therapy for AMI cardiogenic shock. Impella’s label will get an update based on Recover III.

Filed Under: Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Abiomed

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