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Recently, the innovative product Implantable Left Ventricular Assist System of Shenzhen Core Medical Technology Co., Ltd is approved by China NMPA, which is the fourth domestic Implantable Left Ventricular Assist System.
This product is composed of implanted parts, external parts and surgical accessories, and is used together with specific artificial blood vessels to provide mechanical support for the blood circulation of patients with progressive refractory left heart failure, and is indicated for transitional treatment before heart transplantation or to restore heart function.
This product is the third generation non-contact magnetic levitation centrifugal pump, with the core technology of disc motor technology. It uses position sensors to detect and control the rotor speed and suspension height. The motor of this product only uses a set of stator coils to control the rotation and suspension of the rotor at the same time, which enables this product with simpler structure, lighter weight, smaller size, and lower power consumption. In clinical trials, the surgical incision is smaller and thus patients recover faster. It is applicable to a wider population, and can reduce the risk of thrombosis caused by pump heat.
The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.