Sam Brusco, Associate Editor08.21.23
magAssist has been granted U.S. Food and Drug Administration (FDA) breakthrough status for its NyokAssist interventional ventricular assist device (VAD).
According to the company, interventional VADs have been proven as effective for mechanical circulatory support for high-risk percutaneous interventions but their insertion size has been correlated with vascular complications, bleeding, blood transfusion, and severe adverse cardiovascular events. Because reducing interventional size could mitigate risk of these complications, magAssist’s team incorporated size as a key product design element.
NyokAssist has a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal, reducing the vascular access and closure process. Once positioned, the catheter pump operates in its unfolded form for sufficient blood flow. The pump’s impeller aims to deliver greater hydraulic efficiency, even at lower speeds of rotation.
The interventional VAD was developed with an external motor that sits outside the body, also to reduce access size and minimize hemolysis risk due to motor overheating.
magAssist’s other products include an extracorporeal ventricular assist device (extra-VAD), interventional ventricular assist device, extracorporeal membrane oxygenation systems (ECMO) and organ care systems.
According to the company, interventional VADs have been proven as effective for mechanical circulatory support for high-risk percutaneous interventions but their insertion size has been correlated with vascular complications, bleeding, blood transfusion, and severe adverse cardiovascular events. Because reducing interventional size could mitigate risk of these complications, magAssist’s team incorporated size as a key product design element.
NyokAssist has a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal, reducing the vascular access and closure process. Once positioned, the catheter pump operates in its unfolded form for sufficient blood flow. The pump’s impeller aims to deliver greater hydraulic efficiency, even at lower speeds of rotation.
The interventional VAD was developed with an external motor that sits outside the body, also to reduce access size and minimize hemolysis risk due to motor overheating.
magAssist’s other products include an extracorporeal ventricular assist device (extra-VAD), interventional ventricular assist device, extracorporeal membrane oxygenation systems (ECMO) and organ care systems.