Investigators presented results at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Dr. Amir Kaki led the FDA IDE study — the first completed pivotal trial for Impella ECP — as principal investigator.
J&J said the study, which met its primary endpoint, enrolled 256 patients at 18 sites in the U.S. Its MACCE (Major Adverse Cardiac and Cerebrovascular Events) rate at 30 days came in at 6.3%. That landed significantly below the pre-defined performance goal, according to a news release.
The company said Impella ECP demonstrated safety and efficacy for use in high-risk percutaneous coronary interventions (PCI). Operators chose the 8Fr Angio-Seal as the first closure method in 70% of patients, registering a 92% success rate.
Impella ECP features a 9 Fr size at insertion for implantation and removal using small bore access and closure techniques. After insertion, it expands to 21 Fr to provide circulatory support and left ventricular (LV) unloading for high-risk PCI. The device remains investigational, but Johnson & Johnson said it plans to submit Impella ECP to the FDA as a next step.
“The study met its prespecified 30-day primary endpoint with low complication rates and the 9Fr arterial access enabled a high success rate closing with an 8 Fr Angio-Seal,” said Kaki. “Impella ECP technology with small-bore access and closure offers benefits for patients and physicians.”
