MagAssist’s NyokAssist Ventricular Assist Device Granted FDA Breakthrough Device Designation

August 31, 2023—MagAssist Co., Ltd, a China-based developer of circulatory support devices for acute/severe cardiac and pulmonary failure, recently announced that the company’s NyokAssist interventional ventricular assist device (VAD) has been granted Breakthrough Device designation by the FDA.

According to the company, NyokAssist features include a 9-F insertion size and a foldable catheter pump to facilitate the insertion and removal from the body, reducing vascular access and closure process. When it is positioned, the catheter pump is designed to operate in its unfolded form to ensure sufficient blood flow.

Additionally, an impeller within the pump is expected to deliver greater hydraulic efficiency, even at lower rotation speeds. An external motor that sits outside the body is designed to reduce access size and minimize the risk of hemolysis caused by motor overheating.

MagAssist noted that its products include the NyokAssist interventional VAD, an extracorporeal VAD (MoyoAssist Extra-VAD), extracorporeal membrane oxygenation systems, and organ care systems. The company has completed clinical trial enrollment in China for its first product, the MoyoAssist Extra-VAD.