China has successfully developed its first generation of biodegradable stents. At the 2008 China Interventional Cardiology Conference, the clinical trial results of the EXCEL rapamycin-eluting stent, China’s first biodegradable stent, were officially announced. Following the largest multi-center clinical registry study in China—known as the CREATE study—the device demonstrated a significant reduction in both restenosis rates and late thrombosis.
Professor Yan Yaling, head of the research department and the Institute of Cardiovascular Diseases at the General Hospital of Shenyang Military Region, highlighted that this is the first biodegradable drug-coated stent developed in China. It utilizes biodegradable polylactic acid as a drug-loading layer, which degrades into water and carbon dioxide within 3 to 6 months after implantation. As a result, the stent gradually becomes a bare metal stent, offering improved biocompatibility and safety. This design helps reduce the risk of restenosis and late thrombosis.
The study involved 59 centers across four countries, enrolling 2,077 patients with coronary artery disease. With 12 months of clinical follow-up and angiographic review, the findings provided strong evidence-based support for the stent's effectiveness.
For the first time, the stent features a biodegradable coating material and a unique single-sided coating design on the luminal side. While its performance is comparable to foreign counterparts, it is priced at about one-fifth of the first-generation similar products from abroad. This affordability makes it accessible to a broader range of patients. Additionally, the reduced need for long-term dual antiplatelet therapy after surgery further eases the financial burden on patients. ——Shanghai Medical Device Industry Association
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