magAssist Receives FDA Breakthrough Device Designation for NyokAssist™️

2023년 8월 21일 FDA

China Suzhou-based magAssist has received the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for NyokAssist™ Interventional Ventricular Assist Device, reaffirming its unwavering commitment to technological innovation in the field of artificial hearts.

NyokAssist™️ has achieved a 9Fr insertion size and features a collapsible catheter pump to facilitate insertion and removal from the body, reducing vascular access and occlusion. Once in place, the catheter pump is designed to operate in its unfolded form to ensure adequate blood flow. The impeller within the pump is designed to provide greater hydraulic efficiency, even at lower speeds. NyokAssist™️ has been designed with an external motor that sits outside the body to reduce access size and minimise the risk of haemolysis caused by motor overheating.

NyokAssist™️ is being jointly developed by magAssist and the team of Junbo Ge, an academician of Chinese Academy of Sciences, from Zhongshan Hospital of Fudan University. It has already completed the processes of type test and animal testing, and is about to enter clinical trials.

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