magAssist is looking to break into the ventricular assist device market with its NyokAssist interventional ventricular assist device after receiving a breakthrough device designation from the US Food and Drug Administration (FDA).

Interventional ventricular assist devices act as artificial hearts and are used in patients with heart failure, who require mechanical support for maintaining an adequate blood supply. These can also be used to provide mechanical support in percutaneous intervention procedures for treating arterial blockage.

NyokAssist consists of a foldable catheter pump and an external motor. The pump has a small insertion size of 9Fr (approximately 2.97mm in diameter). Following insertion, the pump unfolds to act as an impeller to ensure appropriate blood flow and pressure.

Unlike traditional ventricular assist devices, NyokAssist’s motor sits outside the body to minimise access size of the device and reduce the haemolysis risk due to overheating of the motor. The reduced access size also allows for device implantation without requiring open-heart surgery.

Ventricular assist devices are a growing market, with GlobalData forecasting the market will reach $2.24bn by 2033. Abbott’s HeartMate 3 is the current market leader in the field and was approved by the FDA for less invasive implantation using lateral thoracotomy in 2020.

Earlier this year, magAssist unveiled an extracorporeal membrane oxygenation system, BreathMo. The device is designed to provide mechanical circulatory support in heart or respiratory failure patients.

Additionally, magAssist completed enrolment for a clinical trial testing its extracorporeal ventricular assist device, MoyoAssist, in China.