In collaboration with Shanghai Mallow Medical Instrument Co., Ltd., Prof. Wang Yunbing’s team of the College of Biomedical Engineering/National Engineering Research Center for Biomaterials, and Professor Pan Xiangbin's team from Fuwai Hospital have conducted research to tackle key issues and developed the world’s first biodegradable patent foramen ovale occluder (National Machinery Registration No. 20233131307). This invention provides a new treatment for patients with patent foramen ovale (PFO) in China and worldwide.
Biodegradable foramen ovale occluder and its immediate occlusion effect
PFO is one of the main pathogenic factors of stroke and is closely related to migraine, peripheral arterial embolism, decompression sickness, etc. About a quarter of adults worldwide have PFO, which is one of the most common congenital heart abnormalities among adults.
In recent years, the incidence of stroke has shown a younger trend, and sealing the patent foramen ovale can effectively prevent the occurrence of related stroke and alleviate the symptoms of related diseases.Currently, metallic PFO occluders are widely used in clinical practice. Once the metallic occluder is implanted in the body, it may cause wearing of adjacent structures, thrombosis, hemolysis, nickel allergy, cardiac conduction abnormalities. Therefore, if the occluder is composed of non-toxic, biodegradable materials, the risk of long-term complications can be greatly reduced.
The PFO-degradable occluder is composed of an occluding umbrella disc, interlayer membrane, and suture, which is composed of degradable woven silk. The interlayer membrane is composed of a polyethylene terephthalate (PET) matrix membraneand thesuture is made of degradable nylon thread. After implanting the occluder into the human body, it can achieve immediate occlusion and maintain its structure within 3 months, and the occluder possessesgood memory, biocompatibility, and mechanical properties. The novel biodegradable occluder will bring long-term health benefits and improve quality of life to patients. It is one of the breakthroughs in materials and instruments for cardiovascular and cerebrovascular regeneration and repair worldwide.