MicroPort Scientific Corporation: Delivering an Integrated 'Chinese Solution' to Global Healthcare Challenges

On the evening of September 3, 2018 (UK time), The Lancet, the world’s most authoritative medical journal, published in full the results of the TARGET AC study, a large-scale European clinical trial of the Firehawk (Huoying) sirolimus-targeted eluting coronary stent system independently developed by Shanghai MicroPort Medical (Group) Co., Ltd. This marks the first appearance of a Chinese medical device in The Lancet since its founding nearly 200 years ago.

The TARGET AC study is also the first high-quality, large-scale, multicenter, randomized controlled clinical trial in the international arena that was independently designed and successfully implemented by China’s medical device industry, achieving its primary endpoints. This extremely challenging trial pioneered multiple “firsts” in clinical research within the medical community. “It can be said that the success of this trial represents a milestone event for China’s medical device industry,” summarized Zheng Ming, Vice President of Clinical Medical Affairs at MicroPort Group and Dean of the College of Medical Education and Practice.

“Fire Eagle”: Daring to Compete with the World

Historically, foreign products have held a monopoly in the majority of markets within the medical device sector, particularly in the high-end segment, maintaining an absolute advantage in technological competition. Consequently, there was once a significant gap between domestic Chinese enterprises and their European and American competitors.

MicroPort Headquarters, No. 1601 Zhangdong Road, Zhangjiang Science City

In recent years, with the implementation of national policies encouraging the research, development, and production of innovative medical devices, a large number of independently developed Chinese medical devices with internationally advanced standards have rapidly emerged. In 2004, MicroPort’s “Firebird” coronary drug-eluting stent received regulatory approval for market launch, breaking the monopoly held by imported stent products in China’s coronary intervention field. The success of “Firebird” marked a solid first step for China in the high-end medical device sector.

Driven by the success of its “Firebird” stent, MicroPort began laying the groundwork for the research and development of next-generation drug-eluting stents in 2006. At nearly the same time, a major U.S. medical device giant announced substantial investment in the R&D of next-generation coronary drug-eluting stents. In the race to develop third-generation drug-eluting stents, MicroPort rapidly entered a high-speed track, competing directly with the world’s leading medical device companies.

In 2006, academic debate emerged over whether drug-eluting stents (DES) were more prone to causing thrombosis compared to bare-metal stents (BMS). That same year, late stent thrombosis became a focal point at the European Society of Cardiology (ESC) Congress, drawing unprecedented attention to the safety of drug coatings. MicroPort keenly recognized the industry’s concerns regarding the safety of drug-eluting stents and consequently decided to focus the research and development of its next-generation DES on novel drug coating and elution technologies. This marked the beginning of the “Firebird” stent.

“The reason why early-generation drug-eluting stents were prone to causing late-stage thrombosis is that the high drug concentration loaded on these stents, combined with chronic inflammation induced by non-absorbable polymer carriers, prevented normal endothelial regeneration in the affected vascular segments. This means that the excessively high drug payload and non-absorbable polymer carriers not only failed to provide therapeutic benefits but also exacerbated thrombus formation over time due to deposition in the bloodstream. Therefore, in the development of our next-generation drug-eluting stents, we have adopted a disruptive design featuring fully absorbable polymer carriers for controlled drug release,” said Zhang Jie, Senior Director of Equipment and Process Development at MicroPort, in an interview with reporters.

Disruptive design is bound to bring many difficulties in the development process. The initial challenges of "Fire Eagle" were twofold: first, the "targeting technology," which uses laser scanning and positioning technology similar to that used by Chang'e-3 for lunar landing, to identify surface grooves on a 100-micron-wide stent strut—grooves approximately 600 microns long and wide, with a width of 50 microns and depth of 30 microns; second, drug coating, as there was no available spraying equipment domestically or internationally at the time. To address this, MicroPort independently developed a complete set of proprietary spraying equipment and processes specifically for coating and filling grooves, known as TES Technology.

“The Firebird stent uniformly ‘etches’ nearly 600 micro-grooves onto cobalt-chromium alloy struts that are as thin as a human hair yet exceptionally strong. Through a fully automated three-dimensional printing process, the drug is precisely filled into these micro-grooves, ensuring therapeutic efficacy while significantly reducing both the drug payload and the amount of polymer carrier used,” explained Zhang Jie. He noted that this breakthrough in key technology laid a solid foundation for the ultimate success of the “Firebird” stent.

In the core domain of coronary stents, hailed as the “crown jewel” of high-end medical devices, MicroPort has spent two decades not only achieving a leap from following to matching and ultimately leading in the innovation race, but also pioneering an entirely new “track”—an innovative approach that seeks the lowest drug dosage while ensuring optimal therapeutic efficacy. Characterized by its micro-groove targeted elution design, the Firebird stent has achieved gold-standard efficacy with the lowest drug dosage and minimal side effects among all drug-eluting stents globally. It uniquely combines the enhanced safety profile of bare-metal stents with the superior efficacy of drug-eluting stents—two seemingly contradictory attributes—thereby perfectly avoiding the inherent characteristic drawbacks of bare-metal stents (prone to in-stent restenosis) and early-generation drug-eluting stents (prone to late and very late thrombosis).

Europe and the United States are widely recognized as the regions with the most advanced medical science and the strictest academic standards. The TARGET AC study of MicroPort’s Firehawk stent adopted the most rigorous European and American standards and specifications in its clinical protocol implementation. The trial was conducted entirely in European hospitals, with all procedures performed by authoritative European experts, and all patients enrolled from various European countries. The control group utilized products from Europe and the United States that are currently internationally recognized as the “gold standard” for drug-eluting stents. Adjudication of clinical events was carried out by experts from an independent, authoritative international third-party organization, while data measurement and statistical analysis were handled by an independent core laboratory, ensuring the accuracy and impartiality of data interpretation and clinical outcomes. The success of “Firehawk” has not only broken the century-long monopoly held by European and American nations in the high-end medical device industry but also shattered the long-standing arrogance and prejudice against “Made in China,” thereby pioneering a “Chinese pathway” in the global research and development of coronary stents.

Through 21 years of continuous innovation and R&D, MicroPort has directly disrupted the market share of overseas giants in similar products, forcing significant price reductions and achieving import substitution, thereby benefiting millions of Chinese patients. Currently, import substitution in the drug-eluting stent sector is largely complete, with domestically produced cardiac stents accounting for approximately 75% of the market share, among which MicroPort’s cardiac stents hold a 31.56% market share.

Firehawk™ Sirolimus-Targeted Eluting Coronary Stent System

"Putting People First: The Original Aspiration and Ultimate Goal"

It is not only coronary drug-eluting stents that have earned the “MicroPort” brand respect at home and abroad; over the past two decades, MicroPort has developed one innovative product after another that achieved “first in China” and even “first globally.”

Degenerative knee joint disease, also known as knee osteoarthritis, is one of the most common and disabling conditions among the elderly. In China, the prevalence rate reaches 50% in individuals over 60 years old, and rises to as high as 70% in those over 70. Despite such high prevalence, the domestic market has long lacked a knee prosthesis truly suited for Chinese patients. “A normal human knee shifts posteriorly during flexion, which helps maintain joint stability. However, most current artificial knee implants tend to slide anteriorly involuntarily when the knee is bent after implantation, a phenomenon that is particularly noticeable when descending stairs, causing fear and discomfort in patients. In contrast, MicroPort’s domestically produced SoSuperior minimally invasive knee system adopts a unique highly biomimetic internal-stabilizing ball-and-socket articular surface design. This design concept is backed by more than 20 years of successful clinical experience and extensive follow-up data spanning up to 17 years. The system enables postoperative kinematic characteristics to match those of natural knees, resulting in a more natural and flexible gait. Patients no longer feel as if they are ‘walking on thin ice’ after surgery and can almost ‘forget’ they have undergone knee replacement, thereby further enhancing patient satisfaction,” stated Weng Zixin, President of MicroPort Orthopedics China.

Implantable cardiac pacemakers are currently the only effective treatment for bradycardia that can reduce mortality and improve quality of life. In China, there are approximately 1 million patients with bradycardia, with 300,000 to 400,000 new cases annually; however, only about 100,000 patients receive pacemaker therapy each year. The launch of the Rega series of implantable cardiac pacemakers, manufactured by MicroPort LeadCare (a subsidiary of MicroPort), has broken the long-standing dominance of imported products in the Chinese pacemaker market, ushering in a new era of domestic industrialization for high-end medical equipment and accelerating import substitution. "Rega is currently the smallest dual-chamber pacemaker on the global market, with a volume of only 8 cubic centimeters—more than 30% smaller than imported brands—making it better suited to the generally slimmer physique of Chinese patients. Its service life can reach 10 to 12 years. Its physiological pacing algorithms are at the forefront globally, capable of maximally simulating normal human cardiac rhythm. Furthermore, Rega is priced 20%-30% lower than comparable imported products," stated Zhu Xiaoming, Executive General Manager of MicroPort LeadCare.

With the rising incidence of atherosclerosis, aortic expansion diseases, represented by aortic dissection, have become common in China and are associated with high rates of disability and mortality. The advent of stent-graft endovascular repair has significantly reduced surgical trauma and has gradually become the primary treatment for aortic expansion diseases. However, aortic expansion diseases such as thoracic aortic dissection involving the branch arteries of the aortic arch have long been considered relative contraindications for endovascular therapy due to the lack of suitable endografts. According to Dr. Yuan Zhenyu, Senior Director of R&D at MicroPort Endovastec (a subsidiary of MicroPort), the Castor branched stent-graft, independently developed by MicroPort Endovastec, is the world’s first covered stent capable of simultaneously achieving endovascular repair of the aorta and reconstruction of aortic arch branch arteries through minimally invasive procedures.

On August 28 this year, VitaFlow, China’s first approved self-expanding bovine pericardial bioprosthetic valve independently developed by MicroPort CardioFlow, a subsidiary of MicroPort, was implanted for the first time post-launch, giving a new lease on life to a 70-year-old patient. Aortic stenosis is one of the most common and severe valvular diseases among the elderly, with its prevalence rising significantly with age. In Western countries, the incidence of aortic stenosis is approximately 2% in individuals aged 65 and older, and around 4% in those aged 85 and older. Without timely intervention, the median survival period for patients is two to three years. Transcatheter Aortic Valve Replacement (TAVR) is an interventional procedure that has been adopted in clinical practice in recent years. In China, there are more than 2.8 million patients with severe aortic stenosis. Although interventional therapy for valvular disease started relatively late in China, it has developed rapidly. By the end of 2018, over 100 hospitals in more than 20 provinces and municipalities had performed nearly 2,000 TAVR procedures, indicating substantial clinical demand for TAVR products in the country. “The price of VitaFlow is expected to be more than 30% lower than existing products on the domestic market, which will significantly reduce the overall cost of TAVR procedures and benefit more patients,” said Wu Guojia, Vice President of Marketing and Sales at MicroPort CardioFlow.

MicroPort’s innovative achievements are inseparable from its robust scientific research capabilities and its unwavering commitment to quality.

To date, MicroPort’s minimally invasive coronary stent products have saved the lives of more than 4 million patients worldwide, its orthopedic joint products have benefited over 600,000 patients, and its innovative products in the field of cardiac rhythm management have improved the lives of more than 1 million patients globally. These achievements are attributable not only to MicroPort’s robust R&D capabilities and unwavering commitment to quality, but also to its steadfast adherence to and protection of its original aspiration: “people-oriented” care.

Over the past two decades, MicroPort has shattered global prejudices against “Made in China” with a succession of domestically and even globally leading products, earning recognition and acclaim for meeting “European and American standards.” This Shanghai-based homegrown brand has made its “Chinese voice” heard in the high-end medical device industry—a sector characterized by cutting-edge technology, critical relevance to national welfare and people’s livelihoods, and once tightly monopolized by Western countries—thus taking a significant step toward elevating the international standing of China’s innovative medical devices. Looking ahead, MicroPort remains committed to delivering more innovative, high-quality, premium medical products trusted by patients and physicians worldwide, akin to its Firehawk stent, and to providing more “integrated Chinese solutions” to address global healthcare challenges. (By Dong Zhiwen)