MagAssist has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its NyokAssist interventional ventricular assist device (VAD).

The Chinese medical devices company has designed NyokAssist to provide mechanical circulatory support for high-risk percutaneous interventions.

The interventional VAD of the company has currently an insertion size of 9Fr and features a foldable catheter pump to enable the insertion and removal from the body. This lowers the vascular access and closure process.

The catheter pump is designed to function in its unfolded shape once it is in place to ensure adequate blood flow.

Even at slower rotational rates, the impeller inside the pump is anticipated to provide improved hydraulic efficiency, magAssist said.

NyokAssist has been built with an external motor that resides outside the body to reduce access size and the risk of haemolysis caused by motor overheating.

In a statement, magAssist said: “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 value for patients’ healthcare and the medical device industry.”

As an effective clinical therapy, the insertion size of interventional VADs is linked to bleeding, vascular complications, blood transfusion, and other harmful cardiovascular events.

According to the Chinese firm, lowering interventional size reduces the risk of vascular problems and better fulfills clinical expectations in the market.

It is considered one of the main factors in product design and technological breakthroughs by the company in its product development process, magAssist said.

The firm is engaged in the development of circulatory support devices for acute/ severe cardiac and pulmonary failure.

Its product portfolio includes extracorporeal VAD (extra-VAD), interventional ventricular assist device, extracorporeal membrane oxygenation systems (ECMO), and organ care systems.