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Home » MagAssist wins FDA breakthrough nod for ventricular assist device

MagAssist wins FDA breakthrough nod for ventricular assist device

August 21, 2023 By Sean Whooley

MagAssist NyokAssist
The NyokAssist system. [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 hydraulic efficiency, even at lower rotation speeds.

MagAssist designed its device with an external motor, situated outside the body. This aims 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,” MagAssist said in a news release. “The company remains committed to advancing medical technology through continued innovation, research and patient-centric solutions that create value for patients’ healthcare and the medical device industry.”

MagAsisst focuses on developing circulatory support devices for acute/severe cardiac and pulmonary failure. Products in addition to NyokAssist include an extracorporeal ventricular assist device (extra-VAD). The company also develops extracorporeal membrane oxygenation systems (ECMO) and organ care systems. Its first product, the MoyoAssist extra-VAD, completed clinical enrollment in China.

Filed Under: Blood Management, Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Vascular Tagged With: FDA, MagAssist

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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