AbstractAtrial septal defect (ASD) is one of the major congenital heart diseases, and transcatheter closure with a cardiac occluder is a modern method to treat ASD with the advantage of mini-invasiveness over traditional surgical closure. While current occlusion devices are mainly made of non-degradable nitinol with superelasticity, the permanent existence of a metal in vivo may trigger potential complications and especially has an adverse effect on the heart development for children. However, it is challenging to invent a superelasticity-free occluder that can be delivered through a catheter but firmly locked after being opened at the target site; it is also much desired for research and development to quickly assess the feasibility of a superelasticity-free occluder in vitro. Herein, a biodegradable poly(L-lactide) (PLLA) occluder composed of a braided PLLA frame as the skeleton and a nonwoven PLLA fabric as the flow-blocking membrane is developed, and a controllable locking structure is designed to enable firm closure for a device even without superelasticity. We also suggest and justify a series of in vitro methods to assess the efficacy of the biodegradable occluder, and the results confirm the reliability of locking, water-blocking, mechanical strength and degradability. It is found that the PLLA fabric with moderate fiber density is optimal for surface endothelialization. We also carry out biological assessments; significant endothelialization and alleviated inflammation response are observed after 6 months of subcutaneous implantation into rabbits. The porcine model illustrates that the biodegradable polymeric occluder can be successfully implanted into the atrial septum via transcatheter intervention; the follow-ups have confirmed the safety and efficacy of this biodegradable polymeric occluder with the controllable locking structure.

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