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Supira Medical is developing the Supira System, a next-generation percutaneous ventricular assist device designed to provide temporary mechanical circulatory support for high-risk PCI and cardiogenic shock patients. The company has received FDA Breakthrough Device Designation and completed enrollment in an early feasibility study in the US. Over 70 patients have been treated in South American trials. The company recently raised $120 million to fund pivotal US studies supporting premarket approval applications.
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