In recent years, nickel-titanium shape memory alloys have been used as the core key material for high-end medical devices, and their applications in neuro-intervention and cardiovascular intervention fields have continued to expand. A domestic company has developed the COMETIU self-expanding intracranial drug-coated stent system, which has successfully obtained the EU MDR CE certification. It has become the world's first intracranial stent to obtain this certification in the same category. This breakthrough is inseparable from the strong support of nickel-titanium alloy materials.
Intracranial vascular surgeries have extremely strict requirements for implanted devices: the blood vessels are tortuous and slender, and the stents need to have super elasticity, fatigue resistance, radial support force, as well as excellent biocompatibility. Nickel-titanium alloy is the ideal material for this scenario. The approved COMETIU stent in this case has a base made of precisely machined nickel-titanium alloy tubes. Relying on the unique shape memory and super elasticity characteristics of nickel-titanium alloy, the stent can pass through narrow and tortuous intracranial blood vessels under compression and automatically release upon reaching the lesion site, adhering to the blood vessel wall and providing stable support for narrowed blood vessels.
In addition to the nickel-titanium alloy substrate, the product adopts a dual-layer coating design. The bottom layer is a PBuMA base coating, and the upper layer is a degradable PLGA coating carrying sirolimus drugs. By combining the unique closed-loop asymmetric grid structure with drug-controlled release technology, it ensures a good fit between the stent and the blood vessel while releasing drugs to inhibit vascular restenosis, directly addressing the clinical pain point of intracranial atherosclerotic stenosis. The EU MDR is the highest entry threshold for high-risk implant medical devices worldwide. Compared to the old MDD, MDR has raised standards comprehensively in clinical evidence, technical documentation, production quality control, and post-market supervision, significantly increasing the review difficulty. Being able to pass the strict MDR review not only indicates that the design and manufacturing quality control system of medical products have reached international standards, but also indirectly confirms that the processing, precise engraving, and coating processes of domestic nickel-titanium alloys have ranked among the top globally.
Looking at the entire industry, special functional metal materials such as nickel-titanium alloys are becoming the core breakthrough point for domestic high-end medical devices to break through. From coronary stents to intracranial interventional devices, domestic enterprises are gradually moving away from simply exporting low-end consumables and are advancing towards original innovation in high-end implant devices for export. Materials are the foundation of medical devices. Only through continuous progress in the performance of nickel-titanium alloy materials and precise processing techniques can more domestic innovative medical devices continuously obtain the entry tickets to the international market.
Domestic neuro-interventional technology has achieved significant breakthroughs at the certification level. However, to truly achieve large-scale penetration of the overseas market, there are still many challenges in multiple aspects such as materials, processes, clinical applications, and commercialization. As the domestic specialty alloy material industry continues to mature, in the future, there will likely be more innovative domestic medical devices based on advanced metal materials, stepping onto the global stage.
Baoji Yibaite New Materials Technology Co., Ltd., located in the high-tech area in Baoji, is a company especially involved in titanium and other metal material product manufacturing and processing. We have sufficient raw material supply, ensure good quality, and offer attractive prices. With its commitment to quality, our company is a dependable supplier.