magAssist's NyokAssist™️ granted Designation by the FDA as a Breakthrough Device

Recently, magAssist's NyokAssist™ Interventional Ventricular Assist Device (hereinafter referred to as NyokAssist™), has been granted designation as a breakthrough device by the U.S. Food and Drug Administration (FDA) in Breakthrough Device Program. This recognition from FDA has reaffirmed magAssist's unwavering dedication to technology innovation in the area of artificial heart in medical device industry.

Interventional VADs have been proven as an effective clinical therapy to 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. As reducing interventional size mitigates the risk of vascular complications and better meets clinical demands in the market, it is incorporated as one of the key factors in product design and technology breakthrough behind magAssist team's dedicated efforts in the product development process.

Currently, NyokAssist™️ has achieved 9Fr insertion size featured with a foldable catheter pump to fasilitate 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.

Receiving Breakthrough Designation for the NyokAssist™️ represents a major milestone for magAssist, showing that the device stands at the forefront of innovation. The company remains committed to advancing medical technology through continued innovation, research and patient-centric solutions that create values for patients healthcare as well as to medical device industry.