In high-risk PCI procedures, interventional artificial hearts serve as a preventive measure to maintain the stability of patients' hemodynamics during surgery, which is crucial for ensuring surgical success and improving prognosis.The only product used clinically worldwide is Johnson & Johnson's Impella CP device, which has not yet entered the Chinese market, leaving China still in a空白阶段.^【2】。

NyokAssist™, developed by magAssist in collaboration with the team led by Academician Ge Junbo from Fudan University's Zhongshan Hospital, responds to the national call and achieves integrated innovation through the intersection of medicine and engineering.An interventional artificial heart product with complete independent intellectual property rights, which has been successfully applied in the first clinical case by Academician Ge Junbo, demonstrating good safety and effectiveness.

NyokAssist™ adopts an innovative foldable impeller design, featuring the world's smallest interventional size of 9Fr (3mm).^【3】, which can minimize bleeding, reduce the occurrence of perioperative and postoperative vascular complications, and meet the usage requirements of patients with thin blood vessels or arterial stenosis. After reaching the predetermined position, the impeller can quickly expand to its operational size, achieving higher flow while running at a lower speed, thereby reducing damage to blood cells caused by high-speed rotation of the impeller. Additionally, the external motor design of NyokAssist™ effectively avoids hemolysis caused by heat generated from an internal motor. Given the large volume of HRPCI surgeries in China, making the high-value motor a reusable component can effectively reduce costs. In summary, NyokAssist™ meets all the requirements of the special review channel for innovative medical devices.

With the orderly progress of the NyokAssist™ clinical trial, it will fill the clinical gap in China, lead independent innovation to the international stage, and benefit more patients.

magAssist (Suzhou) Co., Ltd. was founded in May 2017, led by Dr. Bo-Ling Xu, a young expert of the National Key Talent Project, the first Chinese member of the International Society of Mechanical Circulatory Support (ISMCS), and a distinguished professor at Soochow University. The company was co-founded with an elite team of domestic and international experts specializing in the development of artificial organs. magAssist is dedicated to building a next-generation extracorporeal life support platform for acute and critical care scenarios. Its primary product lines include: minimally invasive interventional artificial heart, extracorporeal fully magnetically levitated artificial heart, a new generation of portable extracorporeal membrane oxygenation system (ECMO), and a warm blood organ transport platform. The extracorporeal fully magnetically levitated artificial heart has completed clinical trials and received approval as an innovative medical device, entering the "green channel" for market approval. The minimally invasive interventional artificial heart has been granted "Breakthrough Device" designation by the U.S. FDA and recognized as an innovative medical device by the National Medical Products Administration, with its first clinical case successfully performed by Academician Jun-Bo Ge of Zhongshan Hospital, Fudan University. In the future, magAssist aims to meet clinical needs across acute and critical care extracorporeal life support scenarios, continuously expanding its product portfolio and developing platforms tailored to different populations, support requirements, and clinical scenarios, serving patients in China and worldwide.