For the first time in nearly 200 years: Chinese medical devices boarded the Lancet

On the evening of September 3, 2018, UK time (6:30 on September 4, Beijing time), the world's top authoritative medical magazine "The Lancet" published the full text of China's national medical device enterprises (Minimum Medical). The result of a large-scale clinical trial (TARGET AC) of the Firehawk (Fire Eagle) coronary rapamycin-targeted eluting stent system (hereinafter referred to as "Fire Eagle Stent"), which was independently developed in Zhangjiang Science City. The publication of "Lancet" for the first time in nearly 200 years has appeared in China's medical devices.

According to the test results, Fire Eagle is the third-generation targeted drug-eluting stent. After implantation in patients, the treated vascular region can heal quickly at the early stage because of its innovative micro-groove-encapsulated drug and biodegradable polymer. The design, as well as the lower drug loading (only one-third of the drug load of similar products can achieve the same effect), the safety is greatly increased, can effectively reduce the occurrence of late thrombosis.

It is understood that in the field of cardiac stents, drug loading is a problem that has been plaguing the industry for many years. At present, traditional mainstream cardiac stents at home and abroad are coated with cytostatics on the surface of metal stents in order to keep blood vessels patency and reduce vascular restenosis. Incidence.

However, there are still some shortcomings in this way: First, if the coating on the surface of the drug stent is in a process of vascular loading, if it encounters a complex lesion such as calcification, it is easy to fall off or break, which may affect the therapeutic effect. At the same time, due to the large amount of the drug, etc. The problem of high incidence of late thrombosis, and secondly, the drug carrying capacity is difficult to control, and it is easy to prematurely lose before reaching the diseased area. It is easy to over-load when it is loaded, and it burdens the human body, and most patients after traditional stent installation Long-term dual antiplatelet therapy is needed. These drugs have certain side effects and are expensive. At present, the cheaper varieties in China are also costing nearly 10,000 yuan per year, which brings a heavy burden to patients.

How can we solve the above problem and perfectly "save" the drug on the stand? After repeated design and comparison, the Fire Eagle R&D team lasted for 15 years and chose the technical solution of micro-slot wrapped drugs, that is, laser engraving on the surface of the metal stent, and then the medicine was poured into the tank. The difference from the traditional technology is that the groove can prevent the coating from falling off during the transportation process, the drug will not be lost, and the drug can be accurately released through the fixed slot after the drug reaches the vascular lesion area, thereby avoiding waste. And because of the precise release rather than the aimless "sweeping", it can avoid the drug on the invalid side, thus avoiding the inhibition of epidermal cells by too much drug, so that the stent is covered by the epidermis as soon as possible, which allows the drug stent user to take double anti-surgery after surgery. The time for platelet drugs is shortened. Studies have shown that users of Fire Eagle stents are expected to take dual antiplatelet drugs from long-term treatment to one month, saving nearly 10,000 per year for patients, and saving more if you take other new anti-platelet aggregation drugs. It can save nearly 6 billion yuan for the national medical insurance every year.

It is worth mentioning that, because the wall of the stent is as thin as the hair and the space is extremely limited, the manufacturing process of the Eagle bracket is to evenly “dig” nearly 600 grooves on the cobalt-chromium alloy which is as thin as the hair. The difficulty is much higher than the "carving". Because the application of the drug on the ineffective surface (inner wall) is avoided, the inhibition of the endothelial cells by the drug is avoided, so that the surface of the stent can be covered by the endothelial cells as soon as the bare stent, and the result is that while ensuring the effectiveness of the drug, The amount of drug used has been reduced, and the current dose of the Fire Eagle stent is the lowest in the world.

At the same time, since the medicine is tightly wrapped by hundreds of micro-grooves spread over the outer surface of the stent rod, the drug is not ineffective due to blood flushing or scraping with the blood vessel wall during delivery of the stent to the lesion. loss. After the stent is released, the stent rod is embedded in the vessel wall, and hundreds of potentials are arranged in the microgroove (the slot opening area only accounts for less than 5% of the total metal area, maintaining the basic shape of the bare stent) and is immediately converted into an equivalent shape in function. The micro-needle injection hole is arranged in the array, and the drug macromolecule in the needle groove is accurately released to the smooth muscle cells through the directed point irrigation and the fan-shaped diffusion according to a certain controllable kinetic mode; it is this non-redundant optimal dose pre-predetermination The buried and lossless drug delivery mechanism allows the Fire Eagle stent to achieve the effect of preventing restenosis with minimal dose, which is the ratio of this low dose and very high bare stent surface area (about 95%). The late-throat event of the Firehawk product is as low as the bare stent, which effectively avoids the negative effect of the drug on the endothelialization of the stent, overcomes the inherent late thrombosis problem of the general drug-coated stent, and fundamentally enables the Fire Eagle targeting stent to be obtained. The efficacy of common drug stents while maintaining the long-term safety of bare metal stents.

In addition, in order to accurately inject the drug into these micro-grooves, Mini-Chuang has also independently developed a drug-coated spray equipment, fully automatic three-dimensional printing micro-groove filling, which can control the error to the micron level, and the area of ​​the drug coating only accounts for metal. Covering 20% ​​of the area.

At present, the Fire Eagle stent has been listed or completed in 36 countries and regions around the world. It is also known that the second generation of biodegradable drug stents developed by Minimally Invasive Medicine has entered the clinical stage. Clinical safety and effective validation have been preliminary. Good results.

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