Recently, PeriSorb™, a fully degradable peripheral vascular drug-eluting stent system independently developed by Beijing Amet, has been approved to carry out registration clinical trials after the review and approval of the Medical Device Technology Review Center of the National Medical Products Administration (NMPA). https://www.cmde.org.cn/CL0191/23968.html?WxUg5ztDmi=1629961936649). This clinical trial will be launched in a number of tertiary hospitals across the country in the near future. This is the second fully degradable drug-eluting stent to enter clinical research after the company's fully degradable coronary drug-eluting stent (AMSorb®) launched a large-scale randomized controlled clinical trial.

PeriSorb™, a fully degradable peripheral vascular drug-eluting stent system developed with a number of patented technologies, has successively won the Ministry of Science and Technology's "13th Five-Year" National Key R&D Program Key Project, Zhongguancun Disruptive Technology R&D and Achievement Transformation Project, Funding support for a number of scientific research projects such as preclinical and clinical research from Beijing Science and Technology Commission, Daxing District Science and Technology Commission and Zhongguancun Haidian Garden.

In 2018, the "3D printing new generation of fully degradable coronary vascular stent" developed by Amet was rated as a leading innovative technology in China by the Ministry of Industry and Information Technology.

In 2019, Amet's "Major Technological Breakthrough and Industrialization of Biodegradable Vascular Stent 3D Printing" project was listed as a key engineering project of high-precision industry by Beijing.

In 2020, Amet's "3D printing new generation of fully degradable coronary stents" was supported by the Daxing District Major Achievement Transformation Fund.

  background knowledge:

Arteriosclerosis obliterans of the lower extremities is the gradual formation of stenosis or occlusion of the arterial lumen due to atherosclerotic plaques, arterial medial degeneration and secondary thrombosis, resulting in lack of blood perfusion in the lower extremities. The global burden of peripheral arterial disease (PAD) is increasing, with 164 million people suffering from peripheral arterial disease in 2000 and 202 million cases in 2010, an increase of nearly a quarter (23.5%) in prevalence. In China, the prevalence of lower extremity arteriosclerosis obliterans is <5% among people under 60 years old, 5% to 10% among people aged 60-69 years, and about 20% among people over 70 years old. The incidence of peripheral arterial disease increases substantially with age as this population ages. The number of patients with peripheral arterial disease will continue to increase over the next few years. Lower extremity arterial occlusion causes a number of clinical manifestations, ranging from asymptomatic to intermittent claudication (IC), eventually leading to critical lower extremity ischemia (CLI), resulting in a severe decrease in arterial blood flow that compromises the lower extremities. Therefore, the goals of peripheral arterial disease treatment are limb salvage, symptom relief, improvement in functional status, and prevention of cardiovascular events (acute myocardial infarction, stroke, and vascular death).

Peripheral vascular disease requires systematic treatment, the main methods are surgery, endovascular treatment and interventional treatment. Among them, interventional therapy is the first choice for the treatment of peripheral vascular disease because of its small trauma, quick effect, good recovery, and low probability of restenosis. Stent implantation is currently one of the most effective minimally invasive methods for the treatment of PAD. However, the peripheral stents commonly used in clinical practice are permanent metal stents. Permanent metal stents have a high long-term in-stent restenosis rate, The stent is easy to break, and the long-term thrombosis rate is high. The fully degradable peripheral vascular drug-eluting stents that have appeared in recent years are expected to solve the above problems caused by permanent metal stent implantation in vascular interventional therapy. The fully degradable vascular stent combined with the paclitaxel drug coating on the stent surface can play a role in inhibiting excessive intimal hyperplasia. After fully exerting its function, the stent will gradually degrade in the body, and eventually become non-toxic products that can be absorbed by the human body, such as water and carbon dioxide, so that the blood vessels after the stent disappears return to their natural state.