Decade of sword, Junbo Ge academician team developed bioabsorbable stent approved the listing
March 5, by the hospital Shige Academy of Sciences led by Professor Junboresearch and development team, after more than ten years of research and development, scientific research and clinical follow-up study, the country\’s first rapamycin China has independent intellectual property rights of biological elution absorbable stent –XINSORB stand by the State Drug Administration approval to market. This is the second year February 26 Dunlop medical bioresorbable coronary sirolimus-eluting stent system by the National Food and Drug Administration approval, the second paragraph bioabsorbable stent approved domestic market.
First, what is bioabsorbable stent?
Compared with the conventional permanent metal stents, biodegradable (absorbed) by a bracket of biodegradable or absorbable made of a material with good biocompatibility and biodegradability, vascular stenosis degradable stent after implantation site may be, may be effective in the pre-expansion of blood vessels, but also gradually, the degradation product may be absorbed by the body or in vitro without affecting the long-term negative vascular function metabolically. XinSorb bioabsorbable stent and a stent delivery system composed of three parts bracket chassis base, opaque markers, drug carriers coating composition. Restenosis for the primary treatment of atherosclerosis in patients with coronary artery stenosis, coronary flow of the patient and to improve the prevention of the reference vessel diameter 2.75mm-3.75mm, lesion length ≤24mm.
bis, XinSorb advantage bioabsorbable stent
Compared with the conventional metal stent, the product is expected to have the following advantages:
- The final degradation product of the scaffold is water and carbon dioxide, reducing late thrombosis distress;
- the scaffold is completely degraded and absorbed, reduce long-term foreign body inflammatory response;
- is compatible with MRI-CT and the like;
- target lesion restenosis after again facilitate stents;
- the normal physiological function of the diseased vessel intended target will also be partially restored and improved.
Recently, XINSORB FIM clinical study has been completed five years of follow-up showed that TLF rate was 13.3% over the same period foreign Abbott Abbott BVS quite. Considering XIWhen NSORB FIM study conducted, did not use the \”PSP\” optimize implantation techniques, the result is still good. 5 years, only one patient had a stent thrombosis. XINSORB RCT studies have completed four years of follow-up showed XINSORB incidence holder TLF 5.3%, MACE rate was 4.2%, ID-TLR rate was 4.8%, stent thrombosis was 1.0%. This result is fairly conventional drug eluting stent metal, even if the gold standard inlet bioabsorbable stent or a metal stent: Abbott XIENCE stent compared favorably.
Third, the research and development process XinSorb bioabsorbable stents
fifteen years of sword, Junbo Ge academician says it embodies the efforts of the entire R & D team for many years. It is reported that before XINSORB stent market, Ge Yuanshi has also led the development team began the second generation bioabsorbable stents, the current holder of the long-term animal studies have been completed follow-up. And after XINSORB stents on the market, we will continue to carry out post-marketing clinical study.
landmark using biodegradable materials in terms of the stent. Although bioabsorbable stent still many problems, but I believe that with the development of technology, these problems will be properly resolved, biodegradable stents in the treatment of vascular intervention will have a bigger stage.