Supira Medical is focused on developing a percutaneous ventricular assist device (pVAD) called the “Supira System.” This system features a novel low-profile, high continuous flow design, aiming to provide full hemodynamic support for high-risk percutaneous coronary interventions (HRPCI) and cardiogenic shock (CS) patients with a single-device platform. The Supira System boasts a 10F profile designed to minimize vascular complications and includes multiple sensors to provide real-time pressure measurements.
In September 2022, Supira Medical initiated its first-in-human clinical study to evaluate the safety and performance of the Supira System in supporting cardiovascular hemodynamics during HRPCI procedures. The study, led by principal investigator Dr. Adrian Ebner, marked a significant milestone as Supira transitioned into a clinical-stage company.
By November 2023, Supira Medical had received the FDA breakthrough device designation for the Supira System.
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