Frontiers in Cardiovascular Medicine (Apr 2025)

Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study

  • Lu He,
  • Hang Xie,
  • Yongsheng Gao,
  • Gangcheng Zhang,
  • Qunshan Shen,
  • Minghua Wang,
  • Qiguang Wang,
  • Yujiu Wang,
  • Yajuan Du,
  • Xianyang Zhu,
  • Yushun Zhang

DOI
https://doi.org/10.3389/fcvm.2025.1464712
Journal volume & issue
Vol. 12

Abstract

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BackgroundThe next-generation closure device for interventional treatment of patent foramen ovale (PFO) is regarded as biodegradable, yet the corresponding biomaterial technique is still challenging. Herein, we report the clinical application of a novel biodegradable PFO occluder [made of the biodegradable material polydioxanone (PDO)] that is finally coming into clinical use.ObjectivesThis study aimed to assess the safety and efficacy of the biodegradable Pansy® occluder (Mallow Medical, Shanghai, China) for PFO closure in patients exhibiting PFO with a substantial right-to-left shunt (RLS).MethodsSix centers in China participated in this prospective, multicenter study of PFO closure from June 2019 to September 2020. Serious adverse events occurring in the perioperative period and during follow-up were systematically collected. Contrast transthoracic echocardiography (cTTE), transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) were performed during the preoperative and follow-up periods.ResultsA total of 137 patients with a mean age of 38.1 ± 12.4 years who underwent catheter-based PFO closure with the biodegradable Pansy® occluder were included. The procedural success rate was 99.3%. Except for 2 cases (1.4%) of micropericardial effusion, there were no other complications such as cardiac tamponade, major bleeding, stroke oroccluder embolization. During the 12-month follow-up, serious adverse events occurred in 3 patients (2.2%), all of which were device-related thrombus (DRT). Four patients (2.9%) still had moderate to substantial residual RLS. The complete occlusion rate was 97.1% at 12 months after closure.ConclusionsPFO closure with the biodegradable Pansy® occluder can be performed effectively with acceptably low complication rates, low occurrence of adverse events, high procedural success rates and high complete occlusion rates at follow-up.Clinical Trial Registrationhttp://www.chictr.org.cn/index.aspx; identifier (ChiCTR1900024036).

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