▎WuXi AppTec Content Team Report

News on September 11, LePu Heart Medical(hereinafter referred to as XinTai Medical)Announced that its wholly-owned subsidiary, Shanghai Shape Memory Alloy Co., Ltd., has developedMemoSorb Bioabsorbable PFO Occluder（PFO）OccluderOfficially received registration approval from China's National Medical Products Administration (NMPA). According to the press release from Xintai Medical, this innovative device isField of Cardiogenic Stroke Prevention and TreatmentOfBiodegradableThe PFO Occluder is another achievement in Cardial Medical's biodegradable core technology product line.

In recent years, the incidence of stroke has shown a trend of becoming younger, and unexplained strokes in young people have become more frequent. Studies have shown that patent foramen ovale (PFO) is one of the main pathogenic factors of unexplained stroke, and it is also closely related to migraines and peripheral arterial embolism.

PFO is also one of the most common congenital cardiac anomalies in adults. Closure of PFO can effectively prevent related strokes and alleviate symptoms of associated conditions. However, traditional metal PFO occluders, once implanted, remain with the patient for life and may cause complications such as nickel ion release, endocardial tissue erosion, atrial arrhythmias, and thrombosis, while also obstructing future interventional pathways to the left heart system.

MemoSorb Bioabsorbable PFO Occluder was developed by the director of the National Engineering Research Center for Biomaterials, China.Professor Wang Yunbing's Team. The team of Professor Pan Xiangbin from the Yunnan Fuwai Cardiovascular Hospital, China's National Regional Medical Center, jointly developed with Xin Tai Medical. According to the press release from Xin Tai Medical, the product is made of biomedical polymer materials.After implantation into the human body, it will serve as a temporary bridge, guiding autologous tissue biological repair, and then gradually degrade into carbon dioxide and water to be excreted from the body.. The product also achieves "no residual implant" while successfully closing the foramen ovale.Avoiding the potential complications of permanent metal occluders in the body can effectively reduce the incidence of cardioembolic stroke., alleviating symptoms such as dizziness and migraines, while also reserving a safe pathway for future interventional treatments like atrial septal puncture, bringing long-term health benefits and improved quality of life to patients.