FDA approves Impella ECP Pivotal Heart Pump, clinical trial enrolls patients

Abiomed announces the United States Food and Drug Administration FDA has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial. Amir Kaki, MD, director of mechanical circulatory support at Ascension St. John Hospital in Detroit, led the procedures. This single-arm, prospective, multi-center trial will evaluate the rate of major adverse cardiovascular and cerebrovascular events in adult patients who receive Impella ECP support during an elective or urgent high-risk percutaneous coronary intervention PCI.