Safety and efficacy of a novel biodegradable occluder- Pansy ® occluder compared with traditional nondegradable occluder in the closure of patent foramen ovale

Background Traditional nondegradable patent foramen ovale (PFO) occluders pose mechanical complications and may limit potential transseptal access, necessitating biodegradable alternatives without permanent implants. The safety and efficacy of the fully biodegradable Pansy® occluder have not been directly compared with traditional nondegradable devices. Objects To compare the Pansy® occluder with traditional nondegradable occluders for percutaneous closure of PFO, focusing on complications, adverse events, and closure outcomes during follow-up. Methods We retrospectively analyzed consecutive patients who underwent PFO closure with the Pansy® occluder ( n = 44) or traditional nondegradable occluders ( n = 381, predominantly Amplatzer occluder) between June 2019 and June 2020 at the First Affiliated Hospital of Xi'an Jiaotong University. Propensity score matching (1:2) was performed for age, gender, spontaneous right-to-left shunt (RLS) grade, and provokable RLS grade. Outcomes included procedural success, complications, adverse events, effective closure rate, and residual shunt at 6 and 12 months. Results Before matching, Pansy® recipients were younger and included fewer female patients. After matching, baseline characteristics were well balanced. Procedural success was 100% in both groups, with no severe adverse events. Device-related thrombosis occurred in three patients in the Pansy® group (6.82% vs. 0.00%, P = 0.01); all cases resolved after 2–3 months of rivaroxaban without embolic complications. This difference may be influenced by more frequent scheduled TEE surveillance in the Pansy® group. Effective closure rates at 6 and 12 months were comparable between groups (88.64% vs. 87.50%, P = 0.85; 95.45% vs. 92.31%, P = 0.77), with no significant differences in residual shunt. Conclusions The Pansy® occluder demonstrated comparable safety and efficacy compared to nondegradable devices for PFO closure.