Abiomed’s Impella ECP Pivotal Study Investigates Safety, Efficacy for Use in High-Risk PCI

October 28, 2024—Abiomed, part of Johnson & Johnson MedTech, announced the results from the company’s pivotal trial of patients supported with the company’s Impella ECP transvalvular axial flow pump, which features compressible pump architecture. In December 2022, the company announced the start of the pivotal Impella ECP Study.

According to the company, the investigational device exemption (IDE) study enrolled 256 patients at 18 sites in the United States. It met the primary endpoint with a 30-day rate of major adverse cardiac and cerebrovascular events of 6.3%, significantly below the predefined performance goal.

The results were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

Abiomed stated that the study findings demonstrated Impella ECP’s safety and efficacy in high-risk PCI. Operators chose the 8-F Angio-Seal (Terumo Interventional Systems) as the first closure method in 70% of the patients, with a 92% rate of success (defined as hemostasis with the first and only device and no additional closure strategy).

The study was led by principal investigator Amir Kaki, MD, Director of Mechanical Circulatory Support and Complex Coronary Intervention at Henry Ford—St. John Hospital and Medical Center in Detroit, Michigan.

“The study met its prespecified 30-day primary endpoint with low complication rates and the 9-F arterial access enabled a high success rate closing with an 8-F Angio-Seal,” commented Dr. Kaki in Abiomed’s press release. “Impella ECP technology with small-bore access and closure offers benefits for patients and physicians.”

Abiomed stated that the Impella ECP is designed to have a 9-F size at insertion for implantation and removal using small-bore access and closure techniques. After insertion, Impella ECP expands to 21F to provide circulatory support and left ventricular unloading for high-risk PCI.

Impella ECP is an investigational device limited by federal law to investigational use only. The device is in use as part of the FDA-approved continuous access program at selected United States sites. The next step will be to submit Impella ECP for FDA approval, advised the company.