Key result
Biodegradable VSD occluders achieve high procedural success with low rates of conduction disturbances.
Why the study?
Conventional nitinol-based occluders for transcatheter VSD closure carry permanent risks of atrioventricular conduction disturbances, device erosion, and nickel allergy, motivating the development of fully biodegradable occluders to eliminate long-term risks of permanent metallic implants.
Do fully biodegradable VSD occluders provide equivalent closure efficacy while eliminating long-term device-related risks compared to conventional nitinol-based occluders in patients with ventricular septal defect?
Do fully biodegradable VSD occluders provide equivalent closure efficacy while eliminating long-term device-related risks compared to conventional nitinol-based occluders in patients with ventricular septal defect?
Fully biodegradable VSD occluders utilizing PDO and PLLA materials have achieved clinical translation and regulatory approval in China, offering effective defect closure without the permanent risks of metallic implants.
Answers are grounded in this paper and cite their sources.
Early translation of biodegradable VSD occluders warrants clinical caution; leaves open need for randomized validation.
Ventricular septal defect (VSD) is the most prevalent congenital heart disease (CHD), which is approximately 20% of all congenital cardiac defects. Although transcatheter closure of VSD is a favorable alternative to traditional open-heart surgery, conventional nitinol-based occluders carry permanent risks of atrioventricular conduction disturbances, device erosion, and nickel allergy, which precluded regulatory approval in the United States for perimembranous VSD. Fully biodegradable occluders represent an attractive solution, offering equivalent closure efficacy while eliminating the long-term risks due to a permanent metallic implant. Owing to favorable endothelization-degradation kinetics, biocompatibility, and mechanical performance, polydioxanone (PDO) and poly-L-lactic acid (PLLA) have emerged as the superior framework and membrane materials, respectively. Clinical evidence from case series, retrospective cohort studies, and a multicenter randomized controlled trial suggests high procedural success and favorable short- to mid-term safety, with a low incidence of conduction disturbances following biodegradable VSD occluder implantation. In 2022, the National Medical Products Administration (NMPA) of China has granted regulatory approval for the MemoSorb® device, which represents the first clinical available fully biodegradable VSD occluder. This review focuses on biomaterials science, structural design principles, preclinical animal studies, and the emerging clinical evidence of fully biodegradable VSD occluder.
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Yang et al. (2026) conducted a review in Ventricular septal defect (VSD). Fully biodegradable ventricular septal defect occluders (polydioxanone framework and poly-L-lactic acid membrane) vs. Conventional nitinol-based occluders was evaluated on Procedural success and short- to mid-term safety (including conduction disturbances). Fully biodegradable VSD occluders made of PDO and PLLA offer high procedural success and favorable short- to mid-term safety with a low incidence of conduction disturbances.
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