Shanghai, China, July 30, 2024 — MicroPort Scientific Corporation (00853.HK) proudly announces that its wholly-owned subsidiary, Shanghai MicroPort Medical (Group) Co., Ltd. (Shanghai MicroPort®), has received official market approval from the National Medical Products Administration (NMPA) for Firesorb®, the world’s first next-generation fully bioresorbable cardiac stent.
Large-scale pre-market clinical studies reveal that Firesorb® performs comparably to permanent drug-eluting stents across all key clinical metrics, including procedural success rates and late lumen loss (LLL). Notably, Firesorb® demonstrates a superior trend in the critical composite endpoint—target lesion failure (TLF), which includes cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization—with a 3-year TLF rate of only 3.5%. This comparative advantage is expected to be more pronounced as the stent fully degrades into water and carbon dioxide after 3 years, eliminating tissue foreign body stimulation. Unlike previous bioresorbable stents, which showed a disadvantageous trend compared to permanent stents, Firesorb® stands out with a thrombosis rate of just 0.32% across all patients in the FUTURE-I, II, and III studies, with no thrombosis event reported in the four-year RCT study. Imaging results also support Firesorb®’s superiority in endothelial coverage rate and speed compared to both permanent and other bioresorbable stents on the market.
During the 18th Oriental Congress of Cardiology and the World Congress of Cardiology (OCC-WCC 2024), Shanghai MicroPort® hosted a product launch event for Firesorb® under the theme “Externalized in Form, Internalized in Heart”. The event featured presentations on Firesorb®’s innovative design and clinical trial data to an audience of hundreds of experts and scholars from around the world. The clinical advantages of Firesorb® received widespread recognition and acclaim from leading cardiovascular experts, including Academician Runlin Gao from Fuwai Hospital, Academician Junbo Ge from Zhongshan Hospital affiliated with Fudan University, and Academician Jian’an Wang from the Second Affiliated Hospital of Zhejiang University School of Medicine, along with Professor Lei Song and Professor Jun Jiang.
Dr. Bin Yue, President of Shanghai MicroPort®, stated: “The Firesorb® stent, which supports diseased vessels in the short term while being fully absorbed and degraded in the body over the mid to long term, is hailed as the ‘future of cardiac stent technology’ with the concept of ‘intervention without implantation’. From Firebird™ to Firehawk® and now to Firesorb®, MicroPort® has demonstrated a commitment to continuous advancement over its 26-year history. Our three flagship products each embody distinct design concepts, technical features, production processes, and manufacturing costs, meeting diverse clinical needs and personalized patient requirements. We are fully prepared to scale up Firesorb® production and are confident that it will join Firebird™ and Firehawk® in making a global impact and saving millions of patients”.
Mr. Lei Jiang, Chairman of Shanghai MicroPort®, commented: “Throughout the 10-year development and 5-year clinical follow-up of Firesorb®, Shanghai MicroPort® has maintained a focus on addressing clinical pain points and adhering to rigorous evidence-based medicine. Firesorb® has undergone extensive scientific validation for safety and efficacy in large-scale clinical trials prior to its approval. The approval of Firesorb® by the NMPA enhances our cardiac stent product line and significantly improves accessibility for patients worldwide. Firesorb® represents not just a flagship product but also our commitment to doctors and patients. We look forward to collaborating with medical experts to fulfill our mission of providing trustworthy and universal access to state-of-the-art solutions of prolonging and reshaping all lives”.
Dr. ZhaoHua Chang, Chairman and CEO of MicroPort® Scientific Corporation, remarked: “During the initial surge of interest in bioresorbable cardiac stents, Shanghai MicroPort® chose not to hastily follow industry trends. Even during the most challenging periods when several products were withdrawn from the market due to unmet clinical endpoints, we made decisive adjustments to our technical approach, focusing on developing new materials, drug delivery methods, and innovative delivery systems. This perseverance resulted in an ideal product. The resolution of major clinical issues, such as high target lesion failure rates and late-stage thrombosis, can be attributed to precise drug delivery, thin-walled material design, a significant reduction in drug and degradation loads, along with the reasonable balance and interaction between these factors.
We sincerely thank the countless medical experts worldwide, especially Chinese doctors, for their active participation throughout the process. We hope to continue receiving understanding and support from all sectors of society, including industry peers, as we move forward with the promotion of this new medical solution, embodying the universal medical philosophy that ‘The sun and the moon shine on all without neglecting the smallest, and the rain and dew nourish all without disregarding the tiniest’.”