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At the 2025 China International Fair for Trade in Services (CIFTIS), Amite Medical Devices (Beijing) Co., Ltd. showcased its fully degradable absorbable peripheral vascular stent manufactured using digital 3D printing technology, drawing significant industry attention. This innovative product represents a major breakthrough in vascular interventional therapy, offering better treatment options for patients with lower extremity arterial diseases.
The stent is made from new material jointly developed by Amite and Shanghai Fudan University, over a decade-long R&D process. Unlike traditional metal stents, this product uses advanced 3D printing for integrated forming and is fully biodegradable. After implantation, it gradually degrades into water and carbon dioxide, absorbed by the body, avoiding long-term complications from permanent metal stents.
In materials science, the R&D team made significant breakthroughs. The new polymer material balances mechanical properties, degradation rate, and biocompatibility optimally. Experimental data show the new material stent has over 30% higher radial support force and 50% longer fatigue life than traditional polylactic acid materials, with degradation time controllable between 12-24 months based on clinical needs. This precise degradation control allows doctors to choose the most suitable product specifications per patient condition.
In production, 3D printing brings revolutionary changes. Traditional stent manufacturing requires multiple processing steps, while 3D printing achieves one-step forming from digital models to finished products, improving production precision and significantly reducing costs. After规模化 production, individual stent costs are estimated to be over 60% lower than imported products.
Clinical applications are broad, especially for diabetic foot, lower extremity arteriosclerosis obliterans, etc. Diabetic patients often have extensive vascular lesions needing multiple interventional treatments, where absorbable stents are particularly advantageous. Clinical trials show patients using this stent have 35% lower restenosis rates and 40% lower revascularization rates than with metal stents, showing significant clinical benefits.
Amite Medical stated the product has completed large-scale clinical trials with over 500 patients, and follow-up data are encouraging. Three-year follow-up results show smooth stent degradation, good vascular remodeling, and significantly lower major adverse cardiovascular events than the control group. The company has submitted a market application to NMPA, expecting approval next year.
Experts believe this product not only represents China's technological progress in absorbable stents but also demonstrates 3D printing's huge potential in medical device manufacturing. With personalized medicine development, it may even be possible to instantly print customized stents based on patient vascular imaging data before surgery, achieving true "tailor-made" precision treatment.
keyword:
NMPA,3D printing,absorbable vascular stent,Amite Medical,CIFTIS,diabetic foot,innovative materials
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