magAssist, a firm based in Suzhou, China, has announced that it has received breakthrough device designation from the US Food and Drug Administration (FDA) for its artificial heart product, the NyokAssist interventional ventricular assist device (VAD). The company highlights that this designation recognizes the cutting-edge design features of its innovative product.
NyokAssist VAD: A Cutting-Edge Interventional Device
The NyokAssist VAD is designed to address the need for small-sized interventional VADs, which can reduce vascular complications or bleeding during percutaneous interventions. The device has achieved a 9Fr insertion size, a significant advancement in the field. It features a foldable catheter pump that enables insertion and removal from the body, thereby reducing the risk of complications during the vascular access and closure process.
External Motor Design for Safety and Efficacy
The NyokAssist VAD is designed with an external motor that remains outside the body. This design choice is part of the company’s efforts to minimize access size and reduce the risk of hemolysis due to motor overheating, enhancing the safety and effectiveness of the device.
