Abiomed’s Pivotal Impella ECP Study Expands Enrollment

April 24, 2023—Abiomed, part of Johnson & Johnson MedTech, announced the expansion of enrollment in the Impella ECP study. The pivotal trial is evaluating the company’s Impella ECP expandable percutaneous heart pump to support high-risk percutaneous coronary intervention (PCI) procedures.

Three hospitals in New Jersey have joined the trial: Hackensack Meridian Hackensack University Medical Center, Morristown Medical Center, and The Valley Hospital in Ridgewood. The sites enrolled male and female patients aged 47 to 80 years.

The study’s National Principal Investigator is Amir Kaki, MD, Director of Mechanical Circulatory Support at Ascension St. John Hospital in Detroit, Michigan. Dr. Kaki performed the first procedures in the trial, as announced in December 2022.

According to the company, the single-arm, prospective, multicenter trial is evaluating the rate of major adverse cardiovascular and cerebrovascular events in adult patients who receive Impella ECP support during an elective or urgent high-risk PCI procedure. Up to 256 patients will be enrolled in the trial.

Abiomed’s Impella ECP is compatible with small-bore access and closure techniques and is 9 F in diameter on insertion and removal from the body. In the body, it expands and supports the heart’s pumping function, providing peak flows up to 5 L/min.

Impella ECP received FDA breakthrough device designation in August 2021. In June 2020, the company announced FDA approval of the Impella ECP early feasibility study, noted the company.