Abiomed’s Impella ECP Pivotal Trial Enrolls First Patients

December 21, 2022—Abiomed announced the commencement of the pivotal Impella ECP Study after receiving FDA approval for investigational use of the version of the Impella ECP expandable percutaneous heart pump that will be evaluated in the pivotal trial.

According to the company, this single-arm, prospective, multicenter trial will assess 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). The Impella ECP pivotal clinical trial, which will enroll up to 217 patients in the United States, received FDA approval on March 2, 2022.

The company reported that the first two patients have been enrolled in the trial. Both patients received Impella ECP support during challenging left main coronary bifurcation stent procedures involving heavily calcified lesions. After the Impella ECP was removed, the first patient was closed with an 8-F closure device.

The procedures were led by Amir Kaki, MD, Director of Mechanical Circulatory Support at Ascension St. John Hospital in Detroit, Michigan. Dr. Kaki is the national principal investigator of the study.

“The research and clinical teams at Ascension St. John are delighted about enrolling the first patients in the Impella ECP FDA pivotal trial,” commented Dr. Kaki in the company’s press release. “Impella ECP advances the opportunity for physicians to provide critical hemodynamic support during high-risk PCI procedures by delivering similar or higher flow compared to other options through a smaller vascular sheath for access. This technology has the potential to improve patient safety and cath lab throughput because of the smaller arteriotomy required for pump placement.”

Abiomed advised that the Impella ECP heart pump is an investigational device limited by federal law to investigational use only.

The Impella ECP is compatible with small bore access and closure techniques with a 9-F diameter upon 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 (EFS). In the EFS to date, 54 patients have been treated, including some patients treated using the pivotal clinical trial protocol.