The Feasibility Study SA is planned as a prospective, single-arm, interventional multi-center study enrolling up to 30 subjects.~The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta.~The Supira System is a temporary ventricular support device indicated for use for a short time during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.