FDA Approves Abiomed’s RECOVER IV Trial
The FDA has given approval to Abiomed for its RECOVER IV randomized clinical trial for acute myocardial infarction (AMI) cardiogenic shock patients.
The trial will test the company’s Impella heart pumps, assessing whether percutaneous coronary intervention (PCI) with Impella support initiated prior to the PCI is superior to percutaneous coronary intervention without Impella support.
The primary endpoint of RECOVER IV is all-cause mortality at 30 days, the company said.
Secondary endpoints include major adverse cardiovascular and cerebrovascular events at 30 days, days alive out of the hospital at six months, recovery of left ventricular function, need for durable ventricular assist device or heart transplant, and health-related quality of life as measured by responses to the Kansas City Cardiomyopathy Questionnaire at one year.