Xinsorb Bioresorbable Scaffold by Ge Junbo Team and Shandong Huaan Receives CIIF Award at the 23rd China International Industry Fair

Sep 20, 2023 08:00 CST Updated 08:00

Huaan

Research and Development, Production of Cardiovascular Stent Products

On September 19, Xinsorb, the first rapamycin-eluting bioresorbable scaffold with China's independent intellectual property rights, developed through 15 years of dedicated efforts by the team of Academician Ge Junbo from Fudan University's Zhongshan Hospital and Shandong Huaan Biotechnology Co., Ltd., received the CIIF Award at the 23rd China International Industry Fair (CIIF) held in Shanghai this year.

It can be said that the Xinsorb stent represents a significant leap forward in China's interventional treatment of coronary heart disease. It is not only a model of industry-academia-research collaboration in China's medical device sector but also a representative product of "Made in China."

Unlike traditional metal stents,Xinsorb Bioresorbable Scaffold Uses Fully Degradable Polylactic Acid (PLLA) as the Stent Matrix Material, Which is Absorbed and Metabolized by the Body After the Vessel Completes Remodeling, Avoiding Long-Term Risks of Permanent Metal Stent Retention in the Body and Eliminating the Restriction of the Metal Cage on Vessel Dilation and Contraction Function.Three to four months after implantation, the structure of the diseased blood vessel is basically fixed and no longer requires support; one year after implantation, the stent begins to gradually degrade into water and carbon dioxide; within four to five years, the stent is naturally metabolized and absorbed by the body, restoring the blood vessel's structure and function to their natural state, ultimately achieving complete repair of the diseased blood vessel.

Since gaining approval from the National Medical Products Administration (NMPA) on March 4, 2020, Xinsorb has been successfully implanted in over 28,000 patients across more than 700 hospitals. It holds the largest market share among similar products. It is projected that in the future, more than 150,000 coronary heart disease patients will benefit annually. Xinsorb is expected to gradually replace metal stents and become a new treatment option for some coronary heart disease patients.

"Bioabsorbable Stent":

Allow patients with coronary heart disease to benefit gradually and in the long term.

"Xin" is the pinyin for the heart "心", and "sorb" is the English suffix for "absorption". Academician Ge Junbo named it "Xinsorb", which intuitively reflects the product's key feature—being absorbable by the heart—and proudly highlights the Chinese element of this innovative stent.

According to the latest edition of the "Report on Cardiovascular Health and Diseases in China," cardiovascular diseases have become the leading cause of death among urban and rural residents in China. Both the morbidity and mortality rates are still on the rise, imposing a heavy burden on families and society. Currently, there are approximately 330 million cardiovascular disease patients in China, including 11.39 million with coronary heart disease. Nearly 1.4 million people require percutaneous coronary intervention (PCI) treatment each year.

Over the past forty years, as one of the important means for treating coronary heart disease, coronary intervention surgery has gone through three historical stages: the era of simple balloon dilation, the era of bare-metal stents, and the current era of drug-eluting metal stents. Due to the non-degradable nature of metal materials, long-term foreign body stimulation causing chronic vascular inflammation leads to 3-5% of patients experiencing in-stent restenosis or stent thrombosis annually. Bioresorbable scaffolds are absorbed and metabolized by the body after the blood vessel completes remodeling. In theory, this significantly reduces the occurrence of long-term stent failure. Against the backdrop of the increasing younger population affected by coronary heart disease, bioresorbable scaffolds have been hailed as the "fourth revolution in coronary intervention treatment."

Academician Ge and the First Patient Treated with Xinsorb Bioresorbable Scaffold

Compared with traditional non-degradable stents, the surgical operation process of the Xinsorb bioresorbable stent is equally convenient. Its core advantages lie in material design and manufacturing technology. Xinsorb uses polylactic acid (PLLA), a fully degradable polymer material, as the stent substrate, and is coated with a layer of fully degradable racemic polylactic acid (PDLLA) as the drug-loading coating. After being implanted into the coronary artery through interventional surgery, it can support narrowed blood vessels and improve myocardial ischemia.

"After being implanted into the human body, it can be absorbed by blood vessels and gradually degrade while maintaining stability. It does not exert permanent pressure or restriction on patients like metal stents do, while in the early stages, it provides the same level of support as a metallic stent. In the long term, after the stent degrades, there will be no foreign body to cause inflammatory reactions, and the natural elasticity of the blood vessel will also be restored." Shen Li, Chief Physician of Cardiology at Zhongshan Hospital and Deputy Director of the Cardiovascular Interventional Therapy Technology and Devices Engineering Research Center under the Ministry of Education, vividly described it as a "disappearing stent," saying, "After completing its mission, it quietly leaves, without taking a single cloud with it."

Imaging of the first patient five years post-surgery

After 15 years of exploration,

Officially approved for marketing and put into use

Over the nearly 20 years of Xinsorb's development, Academician Ge Junbo has led his students through the efforts of several generations to finally realize the initial dream of a "bioresorbable scaffold." "Twenty years ago, I was still a student; twenty years later, I am now a doctoral supervisor," Shen Li remarked.

Development History of Xinsorb

How good is the biocompatibility of the material placed inside the blood vessel? Will it degrade too early to support the blood vessel? Will it cause excessive toxicity... A brand-new medical device must go through complex exploration and multi-party cooperation from the proposal of the idea to its implementation.

Ge Junbo's team initially proposed the idea in 2005. After undergoing a series of attempts including material screening and verification, and conducting experiments on in vitro, small animals, and large animals, as well as following up from short-term results to long-term effects, they finally welcomed the first clinical trial in September 2013. This marked the first case of a domestically produced bioresorbable scaffold implantation in China. In 2021, the team followed up with the first patient 8 years post-operation, and the patient was in good health with fully restored vascular function. As the stent had gradually degraded, the patient also experienced no psychological or physiological burden.

First Patient Implantation

After another seven years since 2013, continued large-scale clinical trials, follow-ups, and rigorous reviews were conducted. Finally, on March 4, 2020, it was approved by the National Medical Products Administration for marketing. Currently, Xinsorb has been put into use in more than 700 hospitals in China and is expected to further expand overseas. "More hospitals can adopt this new technology. Technically speaking, grassroots hospitals capable of performing coronary intervention surgeries can also use it, provided they have a good grasp of the indications and standardized usage," said Shen Li.

Approved for marketing by the National Medical Products Administration on March 4, 2020

"Integration of Medicine and Engineering" Model:

Need to aim for a clinical orientation

In fact, Academician Ge Junbo began to酝酿 the idea of a "biodegradable stent" after returning to China in the late 1990s, and has long been committed to promoting the clinical technology innovation and scientific research成果转化 in cardiovascular diseases in China.

After years of efforts, he led his team to develop the world's first biodegradable coating coronary stent, which is also the world's first drug-eluting stent with a degradable coating. Xinsorb represents another major breakthrough based on this foundation.

During the long exploration process, Ge Junbo's team gradually realized the importance of "medical-engineering integration" and the core elements of innovation, evolving from individual efforts to collaboration with engineering teams.

“From the doctors, by the engineers, for the patients.” Ge Junbo once proposed this viewpoint. He believed that innovation in medical devices must be based on clinical needs – it is the doctors who raise the concept of “whether stents need to be implanted for a long time,” and only then do engineers realize the need to create a degradable material. Subsequently, both parties continuously communicate, collaborate, experiment, and provide feedback, ultimately developing a product that meets both clinical needs and engineering principles.

In order to enhance the original innovation capabilities of Chinese doctors, Academician Ge Junbo advocated for and initiated the China Cardiovascular Innovators Club (CCI). The aim is to integrate doctors, engineers, and enterprises to create an innovation ecosystem that provides a better environment for clinical doctors. Since its establishment in 2015, the CCI has generated more than 100 patents, fostered over 20 startups, and brought many products to market.

Currently, bioresorbable scaffolds still cannot completely replace metal stents. Xinsorb is more suitable for relatively younger patients with relatively simple conditions, and is still not applicable for some complex lesions, such as cases of severe vascular calcification, severe distortion, or diffuse stenosis. In the future, the team will continue to conduct research, further improve the product, expand the range of suitable users, and further promote the "intervention without implantation" concept, seeking more new breakthroughs in original medical devices.

CCI Cardiovascular Doctors Innovation Club

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