MagAssist wins FDA breakthrough nod for ventricular assist device

The NyokAssist device. [Image courtesy of MagAssist]MagAssist announced today that it received breakthrough device designation from the FDA for its NyokAssist ventricular assist device.

The interventional VAD provides mechanical circulatory support for high-risk percutaneous interventions. It features a 9 Fr insertion size with a foldable catheter pump to facilitate insertion and removal. This reduces the vascular access and closure processes.

Its insertion size correlates with vascular complications, bleeding, blood transfusion and severe adverse cardiovascular events. MagAssist says that reducing interventional size mitigates the risk of vascular complications and better meets market demands. The company incorporated this as a key factor in the design of its NyokAssist technology.

Once positioned, MagAssist designed its catheter pump to operate in an unfolded form to ensure sufficient blood flow. It features an impeller within the pump to deliver greater …

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