Our LuX-Valve is designed to treat symptomatic patients with both severe tricuspid regurgitation and high surgical risk. It is expected to become one of the first TTVR products approved for commercialization in the world. The function of the patient's dysfunctional native tricuspid valve is replaced by a prosthetic valve stent through minimally invasive intervention, which has the advantages of less trauma, less pain, and faster recovery. LuX-Valve was designated as a "breakthrough device" by the FDA, and was the first domestically-developed medical device receiving such designation in the field of heart valve disease treatment.
三尖瓣具有瓣环大、瓣叶脆弱、缺乏稳定相连结构等解剖特征,人工瓣膜支架锚定难度高。LuX-Valve使用一系列世界首创设计,解决了此挑战。LuX-Valve采用国际首创非径向支撑力依赖的三尖瓣设计理念,结合创新的多维度固定设计,可于心室中隔锚定瓣膜,并以两个夹持器夹紧三尖瓣自体前叶,可通过贴合而非以径向支撑力方式进行锚定。因此,LuX-Valve能够适应不同大小的瓣环,减少对三尖瓣结构造成影响,并降低心肌组织损伤和传导阻滞风险。同时人工瓣叶由牛心包制成并经过自主研发的JeniGal抗钙化技术预处理以提升我们产品的耐用性。为提高安全性, LuX-Valve亦采用可回收及可调弯输送系统,容许调整释放位置及释放角度,大幅提高手术成功率。
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