Today, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology announced that the first batch of patients implanted with the domestic "Xin Qing" series of fully magnetically levitated artificial hearts have completed their 10-year post-operative follow-up. All devices are functioning perfectly with no failures caused by material aging. This miraculous clinical data is attributed to the new generation of "Ultra-High Purity Biocompatible Fluorosilicone Elastomer" used in key blood-contacting components inside the heart pump. Developed by a startup in Wuhan Optics Valley Bio-city in collaboration with a top German laboratory, this material perfectly balances hemocompatibility, fatigue resistance, and anti-thrombotic performance. Artificial hearts need to beat 2,000-3,000 times per minute year-round, imposing extremely high demands on the material's flexural fatigue resistance. Traditional polyurethane materials are prone to calcification or degradation after long-term service in the body, increasing the risk of thrombosis. The new fluorosilicone elastomer utilizes special plasma grafting technology to construct a biomimetic endothelial cell-affinity layer on the molecular surface, which prevents platelet adhesion and activation while maintaining the material's excellent mechanical strength. Animal experiments and clinical trials indicate that after continuous operation for over 500 million cycles (approximately 10 years) in simulated human body temperature and blood flow environments, the material surface remains as smooth as new, with no micro-cracks or protein deposition. The chief surgeon involved in the operations remarked, "This material gives artificial hearts the true potential for 'lifetime service,' greatly reducing the pain and economic burden of secondary surgeries for patients." Currently, the material has passed US FDA and EU CE certifications. Global orders are expected to exceed 100,000 units in 2026, marking that China has entered the first tier globally in the field of high-end implantable interventional medical device materials.
Fluoro silicone gum IOTA 3110-F series