Abiomed announced the United States Food and Drug Administration 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 (MACCE) in adult patients who receive Impella ECP support during an elective or urgent high-risk percutaneous coronary intervention (PCI). Impella ECP is the world's smallest heart pump and the only heart pump compatible with small bore access and closure techniques. It is 9 Fr in diameter upon insertion and removal from the body.

Once in the body, it expands and supports the heart's pumping function, providing peak flows up to 5 L/min. Both patients enrolled in the trial received Impella ECP support during challenging left main coronary bifurcation stent procedures involving heavily calcified lesions. After Impella ECP was removed, the first patient was closed with an 8 Fr closure device.

In June 2020, the FDA approved the Impella ECP early feasibility study (EFS). Fifty-four patients have been treated to date in the EFS, including some patients treated using the pivotal clinical trial protocol. Impella ECP received FDA breakthrough device designation in August 2021.

This designation demonstrates that Impella ECP meets the FDA's stringent requirements for a breakthrough device. Impella ECP is an investigational device limited by federal law to investigational use only.