Supira Medical’s novel, low-profile percutaneous ventricular assist device aims to support cardiovascular hemodynamics with minimal hemolysis and a low risk of vascular complications for patients undergoing high-risk PCI and those in cardiogenic shock. Dr. Gagan Singh describes the first-in-human (FIH) study, presented at SCAI. 

As part of this prospective, single-arm, single-center study, six patients underwent high-risk PCI with the Supira system. Primary endpoints included procedural and safety outcomes. Procedural success was defined as safe implantation of device, hemodynamic support during the PCI, and successful withdrawal of the device. Safety assessment was defined as freedom from device-related major adverse events (MAE), including vascular complications (access and central), aortic valve injury, mitral valve injury, and systemic embolization.