The device, developed by magAssist, is an interventional ventricular assistance device.
The FDA designated magAssist’s NyokAssist as a breakthrough device.
In a press release from magAssist, the company announced the decision. The designation identifies the NyokAssist as a novel device that has the potential to save lives and treat debilitating diseases.
The NyokAssist is a ventricular assistance device that features a foldable catheter pump. It has been designed to be quickly and easily inserted or removed from the human body. It also includes an external motor which reduces the risk of overheating and ensure sufficient blood flow.