SHENZHEN, China, May 15, 2024 /PRNewswire/ -- Lifetech (stock code: 1302.HK) The world's first product, the IBS® absorbable drug-eluting coronary stent system (hereinafter referred to as the "IBS® coronary stent"), independently developed by Yuanxin Technology (Shenzhen) Co., Ltd., a subsidiary of Yuanxin Technology (Shenzhen), has successfully completed a one-year follow-up of the randomized controlled study (i.e., the "phase II clinical study"). On May 14, 2024 local time in France, Song Lei, director of Fuwai Hospital of the Chinese Academy of Medical Sciences, on behalf of Academician Gao Runlin and all researchers, announced the one-year follow-up results of the phase II clinical study of IBS® coronary stents to the world for the first time at the 2024 European Congress of Interventional Cardiology (EuroPCR), the world's most influential cardiac interventional conference.
The phase II clinical study of IBS® coronary stent is a prospective, multicenter, single-blind, randomized controlled clinical study, and the main endpoint is late lumen loss in the lesion segment two years after coronary stent implantation. The clinical study was officially launched in March 2022, and it took only 9 months to successfully complete the enrollment of all 518 subjects in 36 centers in China, and randomly assigned 1:1 to the experimental group (IBS® coronary stent) and the control group (Xience® everolimus drug-eluting coronary stent). The results of one-year clinical follow-up showed that there was no significant difference in the target lesion failure rate (TLF) between the experimental group and the control group (2.3% in the experimental group and 2.7% in the control group, p=0.78). There was no significant difference in the incidence of cardiac death (0 in the experimental group and 1.2% in the control group, p=0.20) and target vasive-related myocardial infarction (0.4% in the experimental group and 1.2% in the control group, p=0.37) in the two groups, and there were no device-related thrombotic events in the two groups, which preliminarily proved that the IBS® coronary stent was not inferior to the mainstream drug-eluting metal stent in the current market, showing ideal safety and efficacy.
Figure: IBS® coronary stent
Eighteen years of dedicated research and development The world's first fully degradable iron-based resorbable coronary stentCoronary heart disease is one of the most common cardiovascular diseases, with high morbidity and mortality, and seriously threatens human health. Percutaneous coronary intervention has developed rapidly due to its advantages of minimally invasive, time-saving, safe and efficient, and has now become the mainstream treatment of coronary heart disease. According to Frost & Sullivan's forecast, the global use of coronary intervention stents is expected to exceed 12 million by 2030, and its market size is expected to grow to $9.1 billion, making it the largest medical device in a single market. However, because of its non-degradability, permanent metal coronary stents will accompany patients for a lifetime after implantation, making patients need to take medication for life, bear the risk of long-term stent fatigue and rupture, vascular restenosis and limited secondary intervention in the development of atherosclerosis. In recent years, with the continuous development of medicine, "interventional revascularization without implantation" has become a development trend in the field.
The IBS® coronary stent is independently developed by Lifetech after 18 years and is the world's first fully degradable iron-based resorbable coronary stent. Its matrix is made of high-purity nitrided iron pipe with high strength and high plasticity, and the stent wall is thin (55~65μm) and has strong supporting force. Innovative material research and unique technical path enable IBS coronary stents® to retain the advantages of complete specifications of permanent metal coronary stents (φ2.25~4.0*8~38mm), superior physical properties, good biocompatibility, simple operation (no PSP and slow expansion), etc., as well as the characteristics of complete absorption, which can effectively avoid a series of long-term prognostic problems that may be brought about by implantation of permanent metal stents.
Global leader, the future can be expectedIn March 2018, the pre-market clinical study of IBS® coronary stent was launched in China (phase III), with Academician Gao Runlin from Fuwai Hospital of the Chinese Academy of Medical Sciences as the principal investigator (PI), and Academician Ge Junbo and Academician Han Yaling, as well as nearly 40 clinical research centers and experts across the country to participate.
In April 2023, the results of the three-year follow-up of the IBS® coronary stent FIM (i.e., phase I clinical study) were published online in the international authoritative medical journal EuroIntervention. The data showed that the target lesion failure rate (TLF) was only 2.2% at six months after IBS® coronary stent implantation, and the TLF was stable at 6.7% at one, two and three years after implantation, and there were no deaths, myocardial infarctions and thrombotic events throughout the follow-up period. The target angiogenesis intima coverage rate was as high as 99.8% after six months of IBS® coronary stent implantation, and reached 100% after one year, and there was no acquired poor adhesion during the whole degradation process, and the degradation was completed two to three years after successful implantation. It has been preliminarily demonstrated that IBS® coronary stents have good medium-term safety and efficacy in simple primary coronary lesions. In addition, the lumen area of the vessel continues to expand six months after the implantation of the IBS® coronary stent, which is the expected development trend of absorbable stents, reflecting the unique clinical advantages of IBS® coronary stents. The product has now completed the five-year follow-up of FIM with positive results.
The announcement of the one-year follow-up results of the Phase II clinical study of IBS® coronary stent further strengthens the evidence-based medical evidence and confidence in the successful commercialization of this world-first product. At the same time, the product is undergoing a one-year follow-up of a single-arm target value study (i.e., a "Phase III clinical study") in China, which is progressing well. Fully degradable metal coronary stents made of iron have demonstrated great potential and bright prospects for clinical application in current clinical studies. In addition, IBS® coronary stent has successfully submitted an EU CE registration application, which is expected to become the second iron-based absorbable stent product successfully commercialized in the world after IBS Angel™ iron-based absorbable stent system.
With the continuous improvement of follow-up clinical research and evidence-based medicine, the access of this revolutionary innovative product to the global market will be further promoted, bringing unprecedented, safe and effective treatment methods to patients with coronary heart disease around the world in the near future, and will actively promote the treatment of related diseases into the iron-based resorbable era!
About Lifetech Technology
Lifetech Technology Inc. (stock code: 1302.HK) Founded in 1999 in Shenzhen, China, HK) is a leading cardiovascular and cerebrovascular and peripheral vascular interventional medical device company, which is a national high-tech enterprise and the third batch of specialized and new "little giant" enterprises of the Ministry of Industry and Information Technology of the People's Republic of China. The company's products under development and sale cover structural heart disease, peripheral vascular disease, pacing electrophysiology, respiratory intervention, neurointervention and other fields, and has the world's first iron-based bioresorbable material platform, achieving independent innovation and technological breakthroughs in multiple subdivisions. As of December 31, 2023, the company has achieved more than 2,100 high-quality patents, and a total of 15 products have been approved by the National Medical Products Administration (NMPA) to enter the "Special Review Procedure for Innovative Medical Devices". Adhering to the development strategy of "innovation" and "internationalization", the company has long been in the leading position in the market share of its main products on sale, and has subsidiaries and offices in 6 countries around the world, with a sales network covering nearly 120 countries and regions around the world.