Collaborative innovation to lead the world | World’s first fully biodegradable occluder launched

Source: Clinic New Vision
March 14, 2022, 5:55 p.m.

On the morning of March 12, 2022, the National Medical Center Construction Results Conference & Medicine and Engineering and Research Joint Innovation Forum were held in Beijing to reveal the world’s first fully biodegradable occluder!

Several Chinese cardiologists,experts in biomaterial fields and government and enterprise leaders attended the conference and forum to witness this exciting moment together. They were:
Academician Hu Shengshou, Chinese Academy of Engineering; Academician Zhang Xingdong, Chinese Academy of Engineering; Deputy Director Sun Zhicheng, Department of Social Affairs, National Development and Reform Commission; Director Cheng Wei, Medical Health Science and Technology Division, Beijing Municipal Science & Technology Commission and Administrative Committee of Zhongguancun Science Park; Director Zhang Xiao, Medical Health Science and Technology Division, Beijing Municipal Science & Technology Commission; Vice President Wang Jianwei, Chinese Academy of Medical Sciences & Peking Union Medical College; Professor Pan Xiangbin, Director of the Structural Heart Disease Center, Fuwai Hospital, CAMS & PUMC; Professor Wang Yunbing, Director of National Engineering Research Center for Biomaterials, Engineering Research Center in Biomaterial Sichuan University; Professor Qin Yongwen, Changhai Hospital, Naval Medical University; Professor Lai Yongqiang, Director of the Surgical Center for Structural Heart Disease, Beijing Anzhen Hospital, Capital Medical University; Professor Guo Hongchang, Surgical Center for Structural Heart Disease, Beijing Anzhen Hospital, Capital Medical University; Dr. Pu Zhongjie (Ph.D.), Chairman of Lepu Medical Technology (Beijing) Co., Ltd., Mr. Zhang Zhibin, General Manager of Lepu Medical Technology (Beijing) Co., Ltd., Mr. Guo Tongjun, Vice General Manager of Lepu Medical Technology (Beijing) Co., Ltd., and Mr. Zheng Guorui, Vice General Manager of Lepu Medical Technology (Beijing) Co., Ltd.; and Dr. Chen Juan (Ph.D.), Chairman and General Manager of Lepu ScienTech Medical Technology (Shanghai) Co., Ltd. 

MemoSorb® fully biodegradable occluder was recently approved by the National Medical Products Administration for the treatment of ventricular septal defect. MemoSorb® occluder is made of specific medical polymer materials, gives a creative leap in material design, from metal to a biodegradable material. After the job of defect closure, the occluder will gradually degrade and be safely absorbed by human body without any foreign residue, thereby mitigating the risk of long-term complications caused by traditional metal occluders which is permanent in the body after implantation. The occluder also realizes the health concept of “intervention without implantation, implantation without residue” so that children with congenital heart disease can grow up healthy as normal children.

Academician Hu Shengshou addressed the conference and released the National Medical Center construction results. MemoSorb® fully biodegradable occluder is a “first in class” original innovation, jointly developed over a span of nine years by the National Center for Cardiovascular Diseases, Fuwai Hospital, CAMS and National Engineering Research Center for Biomaterials, Engineering Research Center in Biomaterial Sichuan University together with Lepu ScienTech Medical. This product has broken through China’s technology bottleneck in this field and is a typical example of device innovation relying on China’s own technology. The successful development and NMPA approval of a MemoSorb® fully biodegradable occluder opening a biodegradable era, a new pathway of “intervention without implantation” in the treatment of congenital heart disease. This is an important milestone in global interventional therapy for cardiovascular diseases.

Academician Hu Shengshou gave an opening speech

International research and development on biodegradable occluders have been carried out for over a decade. Due to difficulties in radiography imaging of biodegradable materials, several clinical trials of various biodegradable occluders conducted in Europe and America failed—a dilemma for research and development. 

To resolve this problem, Fuwai Hospital adopted a radiation-independent approach, wherein biodegradable materials in the body are clearly visible without metal markers via echocardiography guidance. MemoSorb® fully biodegradable occluder has solved a long-time key difficulty, and for the first time, China is leading the world with a fully biodegradable original technology in the field of structural heart disease, a prime example of Chinese technology overtaking the rest of the world. This original Chinese intellectual property will not only benefit cardiovascular patients in China, but also contribute to the global frontier technology in cardiovascular diseases，delivering the voice of China to the world. 

Academician Zhang Xingdong gave an opening speech

Academician Zhang Xingdong pointed out that the successful development of the world’s first fully biodegradable occluder MemoSorb®, is an original innovation and an excellent example of the integration of industry, university, research, and medicine in China. Early in the 1990s, Chinese scientists found that tissue regeneration could be induced through the optimal design of material composition and structure, and thus they put forth the theory of tissue-inducing biomaterials, breaking the dogma and conventional view that materials cannot regenerate tissue, which gained international recognition. Based on this theory, a series of world-class products such as bone-induced artificial bones, cartilage, nerves, and tendons have been successfully developed and applied in clinical practice. The development and releasing of our fully biodegradable occluder marks the successful application of this theory in the cardiovascular field, and proves that non-living biomaterials can induce the repair and regeneration of heart tissue without the addition of stem cells and growth factors. 

Deputy Director Sun Zhicheng gave an opening speech

Deputy Director Sun Zhicheng from the Department of Social Affairs, National Development and Reform Commission, extended his heartiest congratulations on the successful launch of the MemoSorb® fully biodegradable occluder, and spoke highly of the technology and the successful integration of medicine, engineering, and research. He stated that he was delighted to witness the birth of MemoSorb®, a landmark innovation that is a breakthrough in the treatment of congenital heart disease, and from following to running to leading in the field. The MemoSorb® fully biodegradable occluder is a safe, green, and minimal-invasive approach that independent of radiation,  general anesthesia, and metal residue, and effectively reduces the risk for medical staff and patients. High level technology produces high level products. More advanced devices and equipment are set to emerge in the future, leading to the establishment of more mature innovation systems based on original technology. 

Vice President Wang Jianwei gave a speech

Vice President Wang Jianwei from the Chinese Academy of Medical Sciences expressed thanks to the attending leaders and guests, and extended congratulations on the launch of the world’s first fully biodegradable occluder. This is an innovative product completely self-developed in China, demonstrating an integration between medicine and engineering, and comprehensive collaboration among industry, university, and research; it is also one of the symbolic achievements under the 13th Five-Year Plan of Medical and Health Technology Innovation Project, Chinese Academy of Medical Sciences. The launch of this product has brought good news to children with congenital heart disease, providing a safer and more feasible means for the treatment of congenital heart disease. It has marked a major improvement in China’s medical innovation level and is an ideal response to the General Secretary’s instructions on medical scientific research. 

Professor Pan Xiangbin gave a lecture at the conference

Professor Pan Xiangbin, the main investigator in the clinical research of MemoSorb® fully biodegradable occluder, and who performed the first clinical implantation of the world’s fully biodegradable occluder, presented a vivid and detailed report on the clinical research results. The clinical research project is complete, standardized, scientific, and rigorous, and involved dozens of well-known clinical centers across the country—the product’s safety and efficacy have been fully proven. In addition, the successful development of the fully biodegradable occluder has simplified complex congenital heart disease operations. The occluder is guided purely by ultrasound without the need for radiation, contrast agent, and general anesthesia, and the conditions for surgery can be met even in economically underdeveloped areas, enabling more patients with congenital heart disease to be effectively treated. 

Professor Wang Yunbing gave a lecture at the conference

Chairman Cheng Juan gave a lecture at the conference

Professor Wang Yunbing and Chairman Cheng Juan of Lepu ScienTech Medical welcomed the innovation and development process of the MemoSorb® fully biodegradable occluder. ScienTech Medical is committed to the collaborative innovation of medicine, engineering, and research, to serve clinical practice and benefit patients. Based on the large-scale inter-disciplinary, trans-regional, and trans-departmental integration of the top medicine, engineering, and research units, MemoSorb® fully biodegradable occluder has created an internationally rare collaborative research product, providing key support for China’s original technology, and is a creative leap for China, from being a follower, to now overtaking others. We believe that more world-leading technologies and products will emerge in the future. 

Chairman Pu Zhongjie gave a lecture at the conference

Chairman Pu Zhongjie was exceedingly pleased about the launch of the fully biodegradable occluder. China’s first degradable stent, first pacemaker, first mechanical heart valve, and first artificial intelligence ECG automatic analysis and diagnosis software were all developed in Lepu, while today’s MemoSorb® fully biodegradable occluder is another first—a gratifying result of the company practicing the clinical concept of “intervention without implantation” as it adheres to the principle of technological innovation and iteration. This product will provide more therapeutic options for patients with congenital heart disease. In the future, Lepu will continue it scientific and technological innovation and develop leading products that belong to both China and the world to benefit children with cardiovascular disease worldwide.

At the conference, Professor Qin Yongwen of Changhai Hospital, Naval Medical University, Professor Gianfranco Butera, Director of the Center for Structural Heart Disease, St. Thomas’ Hospital, and other guests also gave speeches, and discussed the collaboration among medicine, engineering, and research. Academician Zhang Xingdong and Chairman Pu Zhongjie presented awards for outstanding contributions to clinical research to the experts involved in the research of the fully biodegradable occluder. 

Professor Qin Yongwen gave a speech

Professor Gianfranco Butera gave a speech online

Academician Zhang Xingdong and Chairman Pu Zhongjie presented awards for outstanding contributions to the experts