From Clinical Needs to Innovation: Two Decades Redefining Cardiovascular Medical Technology

In the past, cardiac surgery was a perilous endeavor with a high mortality rate. Unlike surgeries on other organs, which primarily treat disease by resecting pathological tissues, cardiac surgery requires precise repair of the complex cardiovascular system, posing a severe mental and physical challenge to surgeons. For patients undergoing open-heart surgery, surviving the life-threatening ordeal was itself a great fortune, while the prolonged recovery period and heavy financial burden on families were inevitable costs to bear.

With the development of new surgical techniques and materials in cardiovascular surgery, an increasing number of patients are able to receive better treatment with less trauma, and more clinicians are capable of performing such procedures. Taking the well-known “Sun’s Procedure” in the field of cardiovascular surgery as an example, an experienced surgeon can complete the entire process of thoracotomy, repair, and suturing within four hours. Under comprehensive cardiocerebral protection mechanisms, patients recover rapidly, and the probability of secondary lesions is extremely low.

Such changes are inseparable from clinicians’ meticulous observations and bold innovations derived from extensive practice. In fact, in more mature markets for high-end medical devices, close collaboration between clinicians and engineers has long been a key model for product innovation and iteration. However, during its prolonged catch-up phase, China’s clinical medicine community has been more accustomed to learning and imitation. As clinical practice ventures into increasingly complex and challenging territories, differences in disease spectra across diverse lifestyles and ethnic groups are rendering some established treatment protocols constrained or inadequate in specific contexts.

These disparities were once experienced by Professor Sun Lizhong, then a young cardiac surgeon at Fuwai Hospital, Chinese Academy of Medical Sciences. Over the subsequent decades, many physicians in his clinical team have likewise encountered them. For clinicians, even minuscule inaccuracies in surgical instruments can lead to catastrophic consequences for patients. Leading Chinese cardiac surgeons, represented by Professor Sun, identified opportunities within the limitations of existing treatment protocols. Through a rigorous process spanning conceptualization, modeling, animal studies, and human surgery, they have created new possibilities in clinical cardiac surgery practice and expanded the boundaries of innovation in high-end medical devices in China. Professor Xu Shangdong, Chief Physician of the Department of Cardiac Surgery at Beijing Anzhen Hospital, Capital Medical University, stated that the translation of clinical innovations is not a solitary endeavor but rather a continuous process of product iteration. Only with the participation of more clinicians can such efforts truly succeed.

The beating heart has always been the most mysterious organ in the human body, and a field that modern medicine has reached only after considerable hardship. In 1983, Sun Lizhong graduated from medical school with honors and was assigned to Fuwai Hospital, Chinese Academy of Medical Sciences, then the largest specialized cardiovascular hospital in China, where he became a cardiac surgeon. Driven by immense passion for saving lives, Sun participated in his first aortic surgery during his inaugural year of practice. It was this unsuccessful operation that altered his career trajectory and nearly transformed clinical approaches to treating aortic diseases.

A male patient in his 20s was admitted to Fuwai Hospital due to an aortic aneurysm. The attending physician determined that the treatment plan would involve open-chest surgery, with a foreign expert serving as the lead surgeon and Sun Lizhong providing assistance.Unfortunately, after several hours of effort, the results remained unsatisfactory.Amidst his grief, Sun Lizhong repeatedly reviewed this surgical procedure. After observing aortic surgery cases for a period, Sun discovered that one of the key factors contributing to poor surgical outcomes was the incomplete applicability of imported artificial blood vessels in Chinese patients. Early-generation artificial blood vessels were developed for aortic replacement; when deployed into the aortic lumen using the elephant trunk technique, they presented significant drawbacks, being prone to kinking and twisting. This issue was particularly evident in aortic dissection cases. Due to the small size of the true lumen of the aorta, the artificial vessel was not only difficult to insert but also challenging to fully expand once positioned. If the entry tear was not adequately sealed, the pathology would inevitably recur, and the risk associated with secondary surgery was extremely high, making it difficult for patients to survive the operation.

Since 2003, Professor Sun Lizhong’s team has independently developed stented grafts and pioneered a novel technique for aortic arch replacement combined with the stented elephant trunk procedure, tailored to the morphological characteristics of aortic diseases in China. The stented elephant trunk technique initially addressed the issue of hemorrhage and increased the false lumen closure rate from 34% to 100%, thereby significantly reducing the need for distal aortic surgery. Even when secondary surgery is required, the placement of the stented graft substantially enhances procedural safety. In other words, the stented elephant trunk procedure not only reduces the risks associated with the initial operation but also lowers the likelihood of requiring reintervention. Subsequently, this “Sun’s Procedure” has been widely applied in the treatment of complex Type A aortic dissection and aortic pathologies involving the aortic arch and the aortic isthmus.According to statistics, nearly 80% of Type A aortic dissection cases in China are currently treated with the “Sun’s Procedure.” Among the 25,000 major vascular surgeries performed annually nationwide, over 10,000 are Sun’s Procedures.

Sun Lizhong

President of Shanghai DeltaHealth Hospital

Meanwhile, many clinicians and research teams have developed optimized clinical protocols based on the Sun’s procedure, including multi-branched vascular techniques and suture-free distal anastomosis. More importantly, the evolution of the Sun’s procedure has driven R&D efforts in China in aortic surgery, cerebral protection techniques, myocardial protection techniques, novel aortic surgical procedures, and new biomaterials. Given China’s large population and the complexity of patient conditions, clinical innovation can foster the development of diverse surgical techniques and products, accelerating the market launch of domestically produced stent grafts, synthetic vascular grafts, and other medical devices.

As a typical representative of clinical innovation translation, Professor Sun Lizhong pointed out that medical products require substantial investment, have long development cycles, yield slow returns, and carry high risks of failure. At the outset of initiating clinical innovation translation, it is essential to integrate basic theoretical knowledge with clinical needs and rigorously assess the likelihood of clinical benefit. “One must possess both interest and expertise, as well as wisdom and compassion; none of these elements can be dispensed with.” Technological improvements lacking clinical demand cannot be considered innovation, and product innovations without clinical value, even if ultimately developed, will struggle to sustain their viability during promotion and adoption.

Furthermore, the translation of clinical innovations into practice is a team effort that emphasizes interdisciplinary and cross-professional collaboration. Typically, physicians propose concepts based on patients’ pathophysiology and pathological anatomy—such as the design of the stented elephant trunk technique—while engineers are responsible for implementation. Engineers bring greater expertise in material development, thereby enabling the creation of prototypes, which then undergo product testing and animal experiments,ClinicalExperiments, etc. Even after a product is launched on the market, improvements continue unabated. Taking the frozen elephant trunk procedure as an example, the team of clinicians led by Sun Lizhong has been continuously exploring simpler techniques and better materials. “It is a process of relentless pursuit,” said Sun Lizhong.

Only through unremitting efforts in all aspects can complex procedures be simplified and immature technologies be refined. In the view of Professor Sun Lizhong, major breakthroughs in clinical innovation cannot be achieved by individuals or small teams alone; while individuals and small teams may attain modest achievements, it is large teams that deliver significant outcomes. Throughout this process, team members mutually reinforce one another, thereby facilitating a leap forward in both concepts and technological systems.

Driven by Professor Sun Lizhong’s spirit of exploration and innovative practice, Professor Zheng Jun, Professor Xu Shangdong, and others have subsequently developed innovative products such as artificial blood vessels and stent grafts, based on their extensive clinical experience. These advancements have significantly optimized treatment solutions for aortic diseases and enhanced patient benefits.

In April 2019, the VASOLINE™ synthetic vascular graft, co-developed under the leadership of Director Zheng Jun, was implanted in its first clinical case at Beijing Anzhen Hospital, Capital Medical University. Postoperatively, the surgeons who performed the procedure evaluated the graft as having a soft texture, excellent suturability, and effective hemostatic properties. There was no postoperative bleeding, blood flow within the graft remained patent, and the patient recovered well.

It is understood that the VASOLINE™ synthetic vascular graft is woven from polyester fibers and coated with degradable biomaterials, designed for arterial replacement, repair, and bypass surgeries. Preclinical studies have confirmed that this synthetic graft exhibits minimal blood leakage after implantation, along with excellent handling characteristics and suturability for surgeons. Test results at six months post-implantation demonstrated good biocompatibility and hemocompatibility. As the first domestically developed and manufactured synthetic vascular graft in China, the clinical introduction of VASOLINE™ will fill the gap in this product category within the country and break the monopoly held by imported products.

In China, there is a higher prevalence of patients with aortic dissection. The advantages of imported stent grafts designed for true aneurysms become disadvantages when used to treat aortic dissection; these include overall rigidity, crown-like flaring of the proximal bare stent, and a straight cylindrical configuration of the stent graft body. The use of such stent grafts in dissection treatment has led to two serious complications: one is proximal retrograde dissection, resulting in Type A aortic dissection, and the other is distal aortic dilation, which may even lead to the formation of new entry tears.

Professor Xu Shangdong’s team conducted meticulous research into the anatomical characteristics of aortic dissection and, beginning in 1999, independently developed stent grafts specifically designed for aortic dissection, featuring distinct Chinese characteristics. By 2003, these domestically produced stent grafts underwent their first clinical trials, and in 2005, they passed quality and technical assessments by the State Food and Drug Administration (SFDA), receiving approval for clinical use. Throughout this process, spanning from animal studies to clinical trials, issues were identified, analyzed, and fed back to manufacturers for modification and resolution. Through repeated experimentation by manufacturers, clinicians, and researchers, a stent graft for aortic dissection with Chinese characteristics gradually matured and was refined.

Professor Xu Shangdong pointed out that the improvements to this stent graft were achieved step by step—identifying, analyzing, and resolving issues. “This process lasted five to seven years and also refined our understanding of aortic dissection. Clinical innovation and translation is not a straight line; it is more akin to a continuously rotating circle.”

At present, an increasing number of clinicians are engaging in the translation of clinical innovations, yet most efforts remain isolated and fragmented. In other words, while basic product designs and first-generation prototypes have been developed, progress often stalls during detailed optimization and engineering refinement. Professor Zheng Jun points out that achieving a clinical breakthrough by addressing a single issue is highly challenging. As clinical innovations become more refined, they generate substantial engineering requirements that necessitate professional, enterprise-level teams for implementation. Often, even a single company struggles to meet all product demands, highlighting the need to leverage an increasingly mature industrial ecosystem.

In practice, the clinical translation of innovations typically requires a synchronized three-generation strategy: commercializing one generation, developing the next, and conducting preliminary research on a third. Even with this approach, many failures occur. These include small-vessel products blocked by competitors before completing the clinical translation pathway, and large-vessel products that failed during the regulatory registration process. “Furthermore, there are instances where product iteration outpaces current technological capabilities, necessitating a gradual, pragmatic approach to realization and translation.”

Professor Zheng Jun emphasized that developing a truly successful product requires more than just passion; it demands robust support from a wide range of resources. “While the initial idea is certainly important, it is equally crucial to effectively integrate resources and persevere through challenges.” The journey from clinical trial design and data collection to peer review, expert evaluation, product launch, and high-penetration market adoption is complex and protracted. Professor Zheng pointed out that this process first requires clinicians to have a strong interest in innovation and translation. Second, teams should foster a mentorship culture where experienced members guide newcomers, thereby avoiding common pitfalls and increasing the likelihood of success. Finally, support from the industrial ecosystem is essential, leveraging technology platforms, funding platforms, and commercial service platforms to facilitate the transformation of innovative ideas into tangible products.

Professor Xu Shangdong candidly admitted that when he and his team first embarked on clinical innovation, they did not have a fully formed concept of the final product in mind. However, through the systematic validation of individual ideas, they ultimately developed innovative products that transformed clinical practice. Admittedly, the path from clinical innovation to commercial translation is fraught with challenges and long-term hurdles, but persistent effort will surely lead to success.

2021 FTC China Frontier Forum on Cardiac Surgery

The forum will be jointly hosted by the Cardiac Surgery Professional Technical Committee of the China Medical Education Association and the Cardiovascular Surgery Technology and Engineering Branch of the China Medicine Biotechnology Association. The forum will invite representatives from enterprises, physicians/experts and scholars, universities, Germany, and the investment community to exchange views and discuss two major topics: heart failure and distal aortic dissection. Additionally, the launch ceremony of the Eurasian Medical Technology Association will be held.

Forum Registration Link:http://hdxu.cn/UxRw4

Scan the QR Code to Register

As a concurrent event of the conference, from September 18 to November 5, the Cardiac Surgery Professional Committee of the China Medical Education Association, the Cardiac Surgery Professional Committee of the Chinese Medicine and Biotechnology Engineering Association, and VCBeat jointly launched the “Cardiovascular Technology Innovation Case Call for Entries: ‘Heart Perspective, Heart Thinking’.” This initiative broadly solicits innovative cases in cardiovascular technology from medical institutions at all levels, medical device companies, healthcare service providers, and outstanding projects from specialized colleges and universities within the cardiovascular field. It aims to conduct in-depth analyses of the methodologies, pathways, and outcomes associated with these cases, and to summarize best practices. By facilitating direct dialogue among medical professionals, industry players, and investors, the initiative seeks to break down traditional barriers to the translation of scientific achievements, establish close collaborations, and promote the industrialization of high-quality scientific research outcomes.