Global First: MemoSorb® Bioresorbable PFO Occluder Receives NMPA Approval

Sep 17, 2023 21:02 CST Updated 21:02

Shape Memory Alloy

Structural Heart Disease Medical Product R&D and Manufacturer

"Innovative Technology Creates a Thriving Life, China's Intelligent Manufacturing Leads Global Innovation," Recently, the world's first MemoSorb, independently developed by Shanghai Shape Memory Alloy Co., Ltd. (a wholly-owned subsidiary of MicroPort CardioFlow Medtech Corporation),^®Biodegradable PFO Occluder System Officially Approved by NMPAMedical Device Registration Certificate No.:China Medical Device Registration Certificate No. 20233131307), which is about to enter clinical use in China, may become a new treatment option for patients with patent foramen ovale (PFO) in China and even globally! As another significant breakthrough achieved under China's "integration of medicine and engineering" innovation mechanism in the field of cardiogenic stroke prevention and treatment, MemoSorb^®The bio-degradable PFO occluder will once again send out China's voice to the world, allowing "Intelligent Manufacturing in China" to carry the urgent clinical hopes of patients worldwide!

(Source: Official Website of the National Medical Products Administration)

Integration of Medicine and Engineering: Pioneering the Research of Domestically Produced Devices for the Prevention and Treatment of Cardiogenic Stroke

MemoSorb®

The foramen ovale is one of the vital channels necessary for fetal development. Normally, the primary septum and secondary septum will approach, adhere, and fuse with each other after birth, gradually forming a permanent atrial septum. However, if complete fusion does not occur by the age of 3 or older, the residual slit-like channel is referred to as Patent Foramen Ovale (PFO).In the 1980s, Professor Lechat and others first proposed the association between PFO and cerebral infarction, suggesting that "potential emboli in the veins pass through the foramen ovale, causing paradoxical embolism and leading to stroke events."Relevant studies have found that,The incidence rate of PFO is 30% in individuals aged 1-29 years, 25% in those aged 30-79 years, and 20.2% in individuals over 80 years old. The incidence rate of PFO in adults is approximately 25%, while the prevalence of stroke in PFO patients younger than 55 years old can be as high as 50%., further suggesting that PFO is one of the key factors in cardiogenic stroke, and that the size, degree, and permeability of the foramen ovale are all associated with an increased risk of thromboembolism and stroke.At the same time, the "Annual Report on Interventional Treatment of Patent Foramen Ovale 2022" shows that the number of PFO interventional treatments in China has grown rapidly in recent years.In 2022, the number of PFO treatments (interventional and surgical) in China reached approximately 40,000 cases, ranking first among all interventional procedures for structural heart disease.。

Driven by the urgent needs of a large number of patients with patent foramen ovale (PFO), the "forward wheels" of modern medicine continue to advance towards directions such as "intervention without implantation, implantation without residue." Enhancing the safety, tissue compatibility, and degradability of materials has become an essential path for the development of original interventional devices in China. As another significant achievement in the bioresorbable core technology product line of CardioMems, MemoSor...b^®Biodegradable PFO Occluder, Designed with China's Original Technology at Its Core, Achieves an Innovative Upgrade from Metal to Biodegradable Materials.It not only fully functions as a "temporary bridge" after implantation, but its main structure can also gradually degrade as the endothelialization process progresses, ultimately completing autologous tissue repair. This fully realizes the advanced interventional concept of "intervention without implantation, implantation without residue," providing renewed momentum for the arrival of a green new era in the prevention and treatment of cardiogenic stroke.Believe in MemoSorb^®After the biodegradable PFO occluder is marketed, more patients with patent foramen ovale (PFO) will achieve long-term clinical benefits and enjoy a healthy and normal life just like everyone else!

Degradation Without a Trace, Protecting Both Heart and Brain

MemoSorb®

MemoSorb^®The bio-degradable PFO occluder is made byProfessor Wang Yunbing, Director of the National Engineering Research Center for Biomaterials、Professor Pan Xiangbin's Team at the National Regional Medical Center, Yunnan Fuwai Cardiovascular HospitalUnitedXin Tai Medical, combining medical and engineering expertise, jointly developed.

In recent years, the incidence of stroke has shown a trend of affecting younger populations, with unexplained strokes occurring more frequently among young adults. Research both in China and internationally has indicated that,Patent Foramen Ovale (PFO)It is one of the main pathogenic factors of cryptogenic stroke and is closely related to migraine, peripheral arterial embolism, and decompression sickness. Approximately 40% of patients with cryptogenic stroke and 60% of patients with aura migraines have PFO.

PFO is one of the most common congenital cardiac anomalies in adults, with approximately one-quarter of adults having a patent foramen ovale, according to Frost & Sullivan.In 2021, the number of patients with cardiogenic stroke in China was 4.5 million, and it is expected to reach 5.7 million by 2030.Closure of PFO can effectively prevent related strokes and alleviate symptoms of associated diseases. However, traditional metal PFO occluders, once implanted, will remain with the patient for life and may cause complications such as nickel ion release, endocardial tissue erosion, thrombosis, and atrial arrhythmias.Will impede the subsequent left-heart system intervention pathway。

Against this background, MemoSorb^®The biodegradable PFO occluder emerges as a solution. Made from biomedical high-polymer materials, it serves as a temporary bridge after being implanted in the human body.After guiding autologous tissue biological repair, it gradually degrades into carbon dioxide and water and is excreted from the body.While successfully closing the foramen ovale,Achieve "implantation without residue," avoid the potential complications risk of metal occluders remaining in the body for life, effectively reduce the incidence of cardioembolic stroke, and alleviate symptoms such as migraine and dizziness.It also leaves a safe pathway for future interventional treatments such as atrial septal puncture, bringing long-term health benefits and improved quality of life to patients.

MemoSorb^®The successful launch of the biodegradable PFO occluder,Of great significance for preventing stroke of unknown causes and promoting the development of the "heart-brain co-treatment" discipline in China.In the future, with the further development of its clinical application, it will bring more benefits to a large number of patients, especially young patients.

Source of the article: Chemistry and Materials Science

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