FDA's Distinct Recognition: NyokAssist™ from MagAssist Earns Breakthrough Device Designation

MagAssist's NyokAssist™, an Interventional Ventricular Assist Device, has received a notable achievement by being granted the Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) through its Breakthrough Device Program. This acknowledgment underscores MagAssist's firm commitment to advancing technological innovations in the realm of artificial heart devices within the medical industry.

Interventional Ventricular Assist Devices have established their effectiveness in offering mechanical circulatory support during high-risk percutaneous interventions. Nevertheless, the size of these devices has historically been linked to complications like vascular issues, bleeding, blood transfusions, and severe cardiovascular events. Recognizing the significance of reducing insertion size to mitigate these risks and better align with clinical demands, MagAssist's development team made it a pivotal focus in their product design and technological advancements.

NyokAssist™ currently boasts a streamlined insertion size of only 9Fr and features a collapsible catheter pump, simplifying the insertion and removal processes while minimizing the complexity of vascular access and closure procedures. Once properly positioned, the catheter pump unfolds to ensure optimal blood flow.

The innovative impeller design within the pump enhances hydraulic efficiency, even at lower rotation speeds. NyokAssist™ also incorporates an external motor positioned outside the body, a deliberate design choice aimed at reducing access size and mitigating the risk of motor overheating-induced hemolysis. Securing Breakthrough Designation for NyokAssist™ marks a significant milestone for MagAssist, showcasing their position as leaders in innovation within the field of artificial heart devices.







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