MagAssist's NyokAssist granted Breakthrough Device Designation by the FDA

MagAssist's NyokAssist Interventional Ventricular Assist Device (VAD) has been granted breakthrough device designation by the US Food and Drug Administration’s (FDA) Breakthrough Device Program.

3d rendered illustration of human heart
3d rendered illustration of human heart - Image © AIExplosion – Adobe Stock.

NyokAssist has a foldable catheter pump to facilitate the insertion and removal from the body, reducing vascular access and closure process. Once positioned, the catheter pump is designed to operate in its unfolded form to ensure sufficient blood flow. The impeller within the pump is expected to deliver greater hydraulic efficiency, even at lower rotation speeds. NyokAssist has been developed with an external motor, which sits outside the body, with the design purpose to reduce access size and minimize the risk of hemolysis caused by motor overheating.

Interventional VADs provide mechanical circulatory support for high-risk percutaneous interventions. Their insertion size is correlated with vascular complications, bleeding, blood transfusion and severe adverse cardiovascular events. Reducing interventional size mitigates the risk of vascular complications.