Sichuan University's Professor Wang Yunbing Team Files Patent for a Novel Tissue-Inductive, Fully Bioresorbable Cardiac Occluder

Professor Wang Yunbing’s team at the National Engineering Research Center for Biomaterials, Sichuan University, submitted a in September 2022Patent for a Cardiac Occluder with Tissue-Inducing Regenerative Function and Its Preparation Method. This patent can significantly enhance the tissue-inductive regenerative function of the matrix material, endowing it with favorable anti-inflammatory properties and hemocompatibility, and entered the patent publication stage in April 2023.

It is reported that in June 2022, the fully bioresorbable cardiac occluder jointly developed by Professor Wang Yunbing’s team, Shanghai Shape Memory Alloy Material Co., Ltd., and Fuwai Hospital became the only fully bioresorbable cardiac occluder approved for market launch worldwide. The stent component is made of poly(p-dioxanone), while the flow-obstructing membrane is made of polylactic acid. Its core design features"Fully Degradable + Inducing Tissue Regeneration"。

By precisely regulating the material’s own segmental structure, three-dimensional microporous architecture, and degradation profile—without the addition of exogenous active cells or growth factors—the occluder achieves a favorable match between its dynamic mechanical support and degradation performance and tissue repair.

Interventional occlusion is a minimally invasive procedure used to treat ventricular septal defects. However, traditional metallic occluders remain permanently implanted in the patient’s body, which can lead to various long-term complications and chronic inflammation, while also limiting the feasibility of subsequent therapeutic interventions.

Minimally invasive interventional occluders used for the treatment of congenital heart disease are generally fabricated from nickel-titanium alloy. As these devices remain permanently in the body after implantation, they may cause various long-term complications, such as fretting corrosion, allergic reactions, and conduction block. In contrast, bioresorbable occluders can effectively circumvent the limitations associated with nickel-titanium alloy devices and have long been a focal point of research both domestically and internationally.

In 2006, NMT Medical in Boston, Massachusetts, USA, developed a biodegradable occluder—BioSTAR Occluder,The stent structure of this occluder is composed of non-magnetic nickel-cobalt-chromium-molybdenum alloy, with each of the double discs supported by four alloy metal wires and covered by a flow-blocking membrane made of porcine-derived type I collagen. The successful development and clinical application of the BioSTAR occluder mark the entry of occluder research into the era of biodegradable occluders, providing new insights for numerous researchers.

Researchers at the Singapore Institute of Technology have also developed aFully Biodegradable "Double-Disc" Occluder for Atrial Septal Defect/Patent Foramen Ovale (ASD/PFO)——Double-umbrella occluder. The left and right atrial discs of this occluder are made of PCL, providing superior anchoring. Once delivered to the target site, the device self-expands into a double-disc configuration to seal the defect.

In China,Lepu Medical, Lifetech Scientific, JinKui MedicalBiodegradable occluders have all been developed. Among them, the MemoSorb fully biodegradable occluder, jointly developed by Shanghai Shape Memory Alloy Material Co., Ltd. and the National Engineering Research Center for Biomaterials, was successfully launched in 2022. As the world’s first fully absorbable occluder, it has broken China’s bottleneck dilemma in this field of “always imitating, never surpassing.”

In 2023, Lepu Medtech'sNeoSorb: Second-Generation Fully Bioresorbable PFO OccluderA nationwide multicenter clinical trial has also been launched. Featuring an innovative structure, improved waist design, and optimized flow obstruction, the product is currently enrolling patients. It is reported that Lepu Medical initiated the clinical trial of the fourth-generation MemoSorb Ventricular Septal Defect Occluder in the United States in the fourth quarter of 2023, marking its expansion into overseas markets. In addition, produced by Shanghai Jinkui MedicalPansy Biodegradable PFO OccluderRegistration approval was submitted to the National Medical Products Administration (NMPA) in 2023.

From the perspective of technological development, biodegradable occluders continue to advance. In 2024, the team led by Director Zhang Gangcheng at Zhongnan Hospital of Wuhan University successfully implanted a novel biodegradable ConBrella™ occluder into a patient’s defect site. The entire procedure, performed under local anesthesia and guided by transthoracic echocardiography, was completed in 20 minutes. Postoperative ultrasound demonstrated favorable morphology and positioning of the occluder, with no residual shunt, indicating an ideal occlusion effect. This case also marked the first enrollment in China.