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Exhilarating news: ScienTech Medical’s MemoSorb® Biodegradable Patent Foramen Ovale (PFO) Occluder obtained NMPA approval



      Recently, the National Medical Products Administration (NMPA) of China officially approved the registration of the MemoSorb® Biodegradable Patent Foramen Ovale (PFO) Occluder, independently developed by Shanghai Shape Memory Alloy Co., Ltd., a wholly-owned subsidiary of Lepu ScienTech Medical Technology (Shanghai) Co., Ltd. The medical device registration number is NMPA Approval No. 2022331307.

       As the first biodegradable PFO occluder formally certified and marketed in the field of global cardioembolic stroke (CES) prevention, this device represents a significant achivement of ScienTech Medical's core biodegradable technology. Its successful development and approval lead worldwide CES prevention and treatment of structural heart disease to the biodegradable material era.


(Source: official website of the National Medical Products Administration)




Residue-free implantation; Heart and brain protection in tandem


    Combining their medical and engineering expertise, the teams of Professor Wang Yunbing, the director of the National Biomedical Materials Engineering and Technology Research Center, and Professor Pan Xiangbin from the Fuwai Cardiovascular Hospital of Yunnan Province, a National Regional Medical Center, in collaboration with ScienTech Medica, developed the MemoSorb® Biodegradable Patent Foramen Ovale (PFO) Occluder. 


       Of late, the prevalence of cryptogenic stroke(CS) in younger populations has increased, and a new trend has shown that younger people are experiencing strokes. Studies in China and overseas have shown that the patent foramen ovale (PFO) is a major contributing factor for CS and is closely associated with conditions including migraines, peripheral arterial embolism, and decompression sickness. PFO is seen in about 40% of patients with CS and 60% of patients with migraine auras.


       Approximately one-fourth of adults possess a PFO, rendering it one of the most common congenital cardiac abnormalities. Data from Frost & Sullivan indicate that there were over 4.5 million patients with CES in China in 2021, with an anticipated rise to approximately 5.7 million by 2030. Closing the PFO can effectively prevent related strokes and alleviate associated symptoms. Traditional metal PFO occluders, once implanted, are permanent fixtures within the patients’ bodies for their lifetime. This increases the risk of complications including nickel ion release, endocardial tissue erosion, thrombus formation, and atrial arrhythmias. Additionally, these occluders might impede future interventions involving the left heart system.


      To address this issue, the MemoSorb® Biodegradable PFO Occluder was created. After implantation, it acts as a temporary bridge within the body. It constructed from biomedical polymer components., facilitates autologous tissue repair before gradually breaking down into carbon dioxide and water, which is eventually naturally eliminated from the body. This advancement allows for "residue-free implantation" to ensure successful PFO closure. By eliminating the potential complications linked to permanent metal occluders, the risk of stroke is reduced, and symptoms such as migraines and dizziness are alleviated. Additionally, it creates a secure channel for future interventions like trans-septal puncture so as to improve the long-term health and quality of life of patients.


  The approval and market launch of the MemoSorb® Biodegradable PFO Occluders are pivotal in preventing CS and promoting the holistic approach of "Treating heart and brain together" in China. As its clinical applications expand, it will eventually benefit a wider group of patients, especially young children.



Intensely cultivating expertise and continuous innovation in the field of structural heart disease


      Intensely cultivating expertise and continuous innovation in the field of structural heart disease
ScienTech Medical is a high-tech enterprise dedicated to the research, development, manufacture, and operation of interventional medical devices for structural heart diseases. Through over 20 years of efforts, ScienTech Medical has evolved into one of the leading manufacturers in China, specializing in structural heart disease occlusion devices and related surgical products. We have developed a comprehensive product line and became pioneers in the application of biodegradable technology in the field of structural heart diseases. ScienTech Medical will continue to prioritize innovation of technology in the future while bolstering our core technology platform and independent intellectual property management system. We will also continue to transform the application of biodegradable technology and innovative achievements into higher-quality products and cutting-edge medical solutions for patients in China and around the world.


     As the primary shareholder of ScienTech Medical, Lepu Medical stands as one of the pioneering companies in China and focus on R&D as well as the manufacturing of interventional medical devices for cardiac applications. The company is committed to meeting the rising demands for comprehensive cardiovascular health, elderly care, and rehabilitation services under the current development strategy of "integrating cardiovascular medical devices, cardiovascular pharmaceuticals, medical services, and health management". The Ministry of Science and Technology of China has designated Lepu Medical as the "National Engineering and Technology Research Center for Implantable and Interventional Diagnostic and Therapeutic Medical Devices for Heart Diseases". ScienTech Medical is deeply involved in various national research projects. Lepu Medical has achieved significant advancements in the industry through its independently developed products, which include bioabsorbable stents, drug-eluting balloons, cutting balloons, biodegradable occluders, TAVR valves, and AI-based automated ECG diagnostic systems, which is reaching a high technological standard in the industry.


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