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——The latest clinical results of IBS™ Coronary Scaffold
The world's first product independently developed by Biotyx Medical (Shenzhen) Co., Ltd., theIBS™ Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (hereinafter referred to as "IBS™ Coronary Scaffold"), has successfully completed the one-year follow-up of the prospective, multi-center, single-group target value clinical study (i.e. "Phase III Clinical Study") in China. On October 29, 2024, local time in the United States, Professor Song Lei of the Fuwai Hospital of the Chinese Academy of Medical Sciences, on behalf of Academician Gao Runlin and all researchers, announced the one-year primary endpoint follow-up results of the Phase III clinical study of IBS™ Coronary Scaffold to the world for the first time at the 2024 Transcatheter Cardiovascular Therapeutics Annual Meeting (TCT).
(Photo: Professor Lei Song reports the results of the Phase III clinical study of IBS™ Coronary Scaffold at the TCT conference)
The Phase III clinical study of IBS™ Coronary Scaffold was officially launched in February 2023. The primary endpoint of the study is the target lesion failure rate (TLF) one year after IBS™ Coronary Scaffold implantation. It is the largest clinical trial to date to evaluate the safety and effectiveness of IBS™ Coronary Scaffolds. A total of 1,061 patients were enrolled in the study, including more than 200 subjects who used IBS™ Coronary Scaffolds in the Phase II clinical study and more than 800 subjects who were enrolled in the Phase III clinical study. It took only five months to successfully complete the enrollment of all 800 new subjects in 27 centers in China.
The results of the Phase III clinical study showed that the device success rate of the IBS™ Coronary Scaffold was 99.9%, the lesion success rate was 99.7%, and the surgical success rate was 99.3%. In the one-year follow-up, it showed a meager target lesion failure rate (TLF) of only 2.9%. The one-year follow-up results also showed that the cardiac death was 0%, the target vessel-related myocardial infarction was 1.1%, and the incidence of thrombotic events was only 0.4%. All thrombotic events occurred within one month, and no late thrombotic events have occurred so far. The clinical follow-up results further prove that the IBS™ Coronary Scaffold has ideal safety and effectiveness. The fully degradable metal coronary stent made of iron has demonstrated great clinical application potential and bright prospects in current clinical studies.
As the world's first product, the IBS™ Coronary Scaffold has received great attention from the TCT Conference for its unparalleled innovation and unprecedented clinical value. After the follow-up results were released, the conference held active and heated discussions, and the experts present expressed their high recognition and expectations for the unique product characteristics and technological advancement of the IBS™ Coronary Scaffold.
(Photo: IBS™ Coronary Scaffold)
Eighteen years of dedicated research and development
The world's first fully biodegradable iron-based bioresorbable coronary scaffold
Coronary heart disease is one of the most common cardiovascular diseases, with high morbidity and mortality, which seriously threatens human health. The Percutaneous coronary intervention has developed rapidly due to its advantages of being minimally invasive, time-saving, safe, and efficient, and has now become the mainstream treatment for 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 US$9.1 billion, making it the medical device with the largest single market capacity. However, permanent metal coronary stents are non-degradable and will accompany patients throughout their lives after being implanted in the human body, requiring patients to take medication for life, bear the risk of long-term stent fatigue fracture, and have a series of problems such as limited secondary intervention for vascular restenosis and atherosclerosis. In recent years, with the continuous development of medicine, "intervention without implantation" revascularization has become a development trend in the field.
IBS™ Coronary Scaffold was independently developed by Biotyx Medical after 18 years. It is the world's first fully degradable iron-based bioresorbable coronary scaffold. Its matrix is made of high-strength and high-plasticity high-purity nitrided iron tubes. The stent wall is thin (55~65μm) and has strong support. Innovative material research and unique technical paths have enabled IBS™ Coronary Scaffolds to retain the same specifications as permanent metal coronary stents (φ2.25~4.0*8~38mm), superior physical properties, good biocompatibility, simple operation (no PSP and slow expansion), and other advantages. At the same time, it has the characteristics of being fully absorbable, which can effectively avoid a series of long-term prognosis problems that may be caused by the implantation of permanent metal stents.
Leading the world, promising future
The IBS™ Coronary Scaffold started its pre-market clinical study in China (Phase III) in March 2018, with Academician Gao Runlin as the principal investigator (PI), and Academicians Ge Junbo and Han Yaling, as well as nearly 40 clinical research centers and experts across the country, were invited to participate.
Three-year follow-up of the FIM study
In April 2023, the three-year follow-up results of the FIM study (i.e., Phase I clinical study) of the IBS™ Coronary Scaffold were published online in the international authoritative medical journal EuroIntervention. Data showed that the target lesion failure rate ( TLF) of the IBS™ Coronary Scaffold was only 2.2% six months after implantation, and the target lesion failure rate (TLF) was stable at 6.7% one, two, and three years after implantation. No death, myocardial infarction, or thrombosis occurred during the entire follow-up period; the target vessel neointimal coverage rate of the IBS™ Coronary Scaffold was as high as 99.8% six months after implantation, and reached 100% after one year; there was no acquired poor adhesion during the entire degradation process, and the degradation was completed two to three years after successful implantation. It has been preliminarily proved that the IBS™ Coronary Scaffold has good mid-term safety and effectiveness in simple primary coronary lesions. In addition, the vascular lumen area of the IBS™ Coronary Scaffold continued to expand six months after implantation, which is exactly the expected development trend of absorbable stents and reflects the unique clinical advantages of the IBS™ Coronary Scaffold. The product has completed a five-year follow-up of the FIM study with positive results.
One-year follow-up of phase II clinical trial
In May 2024, the one-year follow-up results of the Phase II clinical study (randomized controlled study) of the IBS™ Coronary Scaffold were first announced to the world at the European Congress of Interventional Cardiology ( EuroPCR ). The clinical results showed that the target lesion failure rate (TLF) of the trial group (IBS™ Coronary Scaffold group) was 2.3%, and the TLF of the control group ( Xience® Everolimus Drug-Eluting Coronary Stent group) was 2.7%. There was no cardiac death or stent thrombosis, which preliminarily proved that the safety and effectiveness of the IBS™ Coronary Scaffold are comparable to the mainstream drug-eluting metal stents currently on the market.
It is worth mentioning that the IBS™ Coronary Scaffold was selected as the "Best Highlights" of coronary devices at this EuroPCR conference, and is one of the only four "Best Highlights" devices at the conference. Professor Davide Capodanno, an Italian cardiologist, and editor-in-chief of EuroIntervention magazine, emphasized in his concluding speech at the closing ceremony of the conference that iron-based bioresorbable stents are one of the important trends in future coronary interventional treatment.
One-year follow-up of phase III clinical trial
The one-year follow-up results of the Phase III clinical study of IBS™ Coronary Scaffolds at TCT, the world's top summit in cardiovascular intervention, showed extremely low target lesion failure (TLF), thrombosis and myocardial infarction rates, which not only provided stronger evidence-based support for the safety and effectiveness of this world-first product but also brought greater confidence in its global commercial success. IBS™ Coronary Scaffolds has previously successfully submitted an application for EU CE registration and is expected to become the second successfully commercialized product under Biotyx Medical's iron-based bioresorbable material platform.
With the continuous improvement of subsequent clinical research and evidence-based medicine, the commercialization process of this revolutionary innovative product in the global market will take greater steps towards success and is expected to bring unprecedented, safe, and effective treatment methods to coronary heart disease patients around the world in the near future. It will also lay a solid foundation for the global development of other core products on the company's iron-based bioresorbable material platform, and promote the treatment of related diseases into the iron-based absorbable era!
