Early Feasibility Study of the Supira System in Patients Undergoing HRPCI

The Supira System is a minimally invasive, miniaturized percutaneous ventricular assist device (pVAD) system that is intended to provide temporary (≤4 hours) hemodynamic support to patients undergoing a HRPCI procedure. The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with a portion remaining in the ascending aorta. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.