On January 4, 2021, the new cardiovascular stent product developed by BJZK Medical Technology Group obtained the CE certificate issued by the EU certification body and obtained the pass certificate for sales in EU countries, which will promote the sales of the product in the international market.
The BJZK research team, with the support of national 863, 973 and other projects, has developed a new medical high-nitrogen nickel-free austenitic stainless steel material with independent intellectual property rights. The material does not add sensitization, easy to cause inflammation and will cause stent implantation. The harmful nickel element of restenosis is replaced by nitrogen and manganese to stabilize the austenite structure, so that the material not only has better biocompatibility and anticoagulant performance, but also has higher mechanical properties and resistance. Pitting corrosion performance, ultra-thin and ultra-fine, can improve the safety and effectiveness of cardiovascular stents in the body.
After several years of hard work, BJZK has solved a series of technical problems such as material smelting, pipe processing, stent structure design, stent surface polishing, and stent surface coating. For the first time in the world, it has achieved the market for nickel-free stainless steel cardiovascular stents. The product has the characteristics of fine stent mesh (0.07mm), good flexibility, and anticoagulant. It can be expanded to be applied to nickel-allergic people and provide safe and effective treatment for more patients.
BJZK develops high-end implant/interventional material and medical device. The company adheres to innovation, safety and pragmatism development concept. Since its establishment, the company has established active research and technical cooperation with the ZK biomedical materials research and development group, Anzhen hospital of capital medical university and Fudan university affiliated Zhongshan hospital, and has successfully developed high nitrogen nickel free stainless steel drug-eluting coronary stent.
Compared with similar products at home and abroad, BJZK stent has unique advantages in metallic material.
High Nitrogen Nickel Free Stainless Steel:
At present, cobalt chromium alloy (L605) and 316L medical stainless steel are widely used as coronary stent metal materials, among which 316L medical stainless steel contains 12-14% nickel and cobalt chromium alloy (L605) contains 10% nickel. Nickel has toxic and side effects such as sensitization, carcinogenesis and teratogenesis. The clinical data showed that the incidence of restenosis after implantation was significantly higher in patients with nickel allergy than in patients without anaphylaxis. The main reason is that the contact allergy with nickel ion in the scaffold material causes inflammatory reaction, stimulates the proliferation of tissue around the scaffold, thus increasing the rate of stent restenosis. At the same time, nickel ions promote the reaction between platelets and leukocytes, leading to thrombosis.
The research is evident that substitution of nickel (Ni) by nitrogen (N) can provide more stable austenite structure and can effectively avert the sensitization and teratogenesis like hazards from human body caused by the release of Ni ion in traditional stainless steel.
Outstanding features:
Excellent mechanical properties
High nitrogen nickel free stainless steel has excellent mechanical properties. The high yield strength of the material provides the stent better anti extrusion performance and effectively prevent the local collapse under the patch extrusion. The fatigue strength of the material can reach 570MPa, which after 20% deformation can reach more than 700MPa. Therefore, the stent has higher safety under the long-term corrosion fatigue.
Stable microstructure
The material has stable austenite structure thus the structure of the stent will not change after the deformation of grip expansion. Moreover, it can keep good corrosion resistance and magnetic compatibility.
Excellent biosafety
The High nitrogen nickel free stainless steel material completely discarded the harmful nickel (Ni) element with sensitization, teratogenesis and carcinogenesis like toxic side effects, and used the human body friendly element nitrogen (N) to replace its effects and form a stable metal structure. It has obvious health effect on nickel sensitive population group. At the same time, the material has excellent anticoagulant properties as well as excellent blood and cell compatibility thus possess better biosafety.
Excellent corrosion resistance
Compared with 316L stainless steel and L605 co Cr alloy, which are currently widely used in clinical cardiovascular stent, the BIONFSS has more excellent corrosion resistance performance. Its pitting potential is as high as 1100-1200 MV, more than three times higher than 316L stainless steel and nearly twice higher than that of L605 co Cr alloy. Therefore, the material has much longer usage safety.
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