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Updated: Aug 14, 2025

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A fully biodegradable polydioxanone occluder for ventricle septal defect closure.

Zefu Li1, Pengxu Kong1, Xiang Liu2,3

  • 1Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Health Commission Key Laboratory of Cardiovascular Regeneration Medicine, National Clinical Research Center for Cardiovascular Diseases, Beijing, China.

Bioactive Materials
|January 12, 2023
PubMed
Summary

A novel biodegradable polydioxanone (PDO) occluder offers a safe and effective alternative for treating ventricular septal defects (VSDs), avoiding metal-related complications.

Keywords:
Biodegradable occluderCongenital heart diseasePolymerTissue regenerationVentricle septal defect

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Area of Science:

  • Biomaterials Science
  • Cardiovascular Research
  • Medical Devices

Background:

  • Ventricular septal defect (VSD) is a common congenital heart defect (CHD).
  • Current nitinol-based occluders pose risks like nickel allergy, myocardial abrasion, and arrhythmia.
  • There is a need for safer, metal-free alternatives for VSD closure.

Purpose of the Study:

  • To develop and evaluate a fully biodegradable polydioxanone (PDO) occluder for VSD closure.
  • To assess the safety, efficacy, and biocompatibility of the PDO occluder compared to nitinol devices.

Main Methods:

  • Development of a PDO occluder with a shape line and poly-l-lactic acid (PLLA) membranes.
  • Evaluation of mechanical properties, biocompatibility, and degradation in a rat subcutaneous implantation model.
  • Assessment of safety and efficacy in a canine VSD model and a pilot clinical trial.

Main Results:

  • The PDO occluder demonstrated excellent mechanical strength, fatigue resistance, and geometry fitness.
  • PDO filaments showed reduced inflammation, fibrosis, and enhanced endothelialization compared to nitinol.
  • Successful VSD closure, positive cardiac remodeling, and absence of adverse events in canine and human trials.

Conclusions:

  • The fully bioresorbable PDO occluder is a safe and effective device for clinical VSD closure.
  • This biodegradable occluder addresses complications associated with metal devices.
  • It shows significant promise for treating structural congenital heart diseases.