Johnson & Johnson says Impella ECP met primary endpoint in high-risk PCI study

Results were presented at Transcatheter Cardiovascular Therapeutics, or TCT, 2024 conference from the first completed pivotal trial on patients supported with Impella ECP, a novel transvalvular axial flow pump with compressible pump architecture. Impella ECP is a technology of Abiomed, part of Johnson & Johnson MedTech, the company noted. The pivotal investigational device exemption study, which enrolled 256 patients at 18 sites in the US, met the primary endpoint. MACCE, or Major Adverse Cardiac and Cerebrovascular Events, rate at 30 days was 6.3%, significantly below the pre-defined performance goal, the company announced. “The study demonstrated Impella ECP’s safety and efficacy for use in high-risk PCI. Operators chose 8Fr Angio-Seal as the first-closure method in 70% of the patients, with a 92% success rate,” the company stated.