A scaffold-degradable single-rivet ASD occluder with amplatzer-like design: a multicenter randomized controlled trial.
Cardiovasc Interv TherJun 19, 2026 (epub)
Liqing Zhao, Jiawei Gao, Xin Zhou et al.
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In 30 seconds
This multicenter randomized controlled trial evaluated the safety and efficacy of a biodegradable Pansy ASD occluder in 112 patients, including 71 pediatric cases. The primary endpoint, closure success rate at six months, was 100% for both the Pansy and metal occluder groups, with no residual shunts detected.
Key findings
- Closure success rate at six months was 100% for both the Pansy and metal occluder groups.
- One patient in the experimental group required device explantation due to abnormal tissue hyperplasia.
- Pathological analysis showed near-complete degradation of the PDO framework with smooth endothelial coverage.
Why it matters
The development of biodegradable occluders like the Pansy may reduce long-term complications associated with metallic devices, offering a safer alternative for patients with atrial septal defects.