The Impella ECP heart pump, developed by Abiomed (a Johnson & Johnson MedTech company), has demonstrated promising safety and efficacy results in high-risk percutaneous coronary intervention (PCI) procedures. New data, presented at TCT 2024 in Washington, D.C., indicate a significantly lower rate of major adverse cardiac and cerebrovascular events than anticipated, potentially paving the way for FDA approval.
The Impella ECP is distinguished by its compact design, measuring only 3 mm in length, and is marketed as the world's smallest heart pump. This transvalvular axial flow pump is engineered to compress, minimizing its size and facilitating easier insertion and removal.
Clinical Trial Results
The investigational device exemption (IDE) study, led by principal investigator Dr. Amir Kaki, involved over 250 patients across 18 U.S. sites. The study's primary endpoint focused on major adverse cardiac and cerebrovascular events (MACCE) within 30 days of the procedure. The observed MACCE rate was 6.3%, substantially lower than the pre-defined performance goal of 24.4%.
Physician Perspective
"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 8Fr Angio-Seal," stated Dr. Kaki, an interventional cardiologist and director of mechanical circulatory support and complex coronary intervention for Henry Ford St. John Hospital and Medical Center. He further emphasized, "Impella ECP technology with small-bore access and closure offers benefits for patients and physicians."
Implications for High-Risk PCI
These findings suggest that the Impella ECP could offer a safer and more effective option for patients undergoing high-risk PCI. The device's smaller size and associated 9Fr arterial access facilitate easier closure, potentially reducing complications and improving patient outcomes. The results from the trial support the use of Impella ECP in complex coronary interventions, and may lead to its approval for broader clinical use.
