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CLINICAL TRIAL article

Front. Cardiovasc. Med.
Sec. Structural Interventional Cardiology
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1464712

Biodegradable Pansy ® Occluder for Patent Foramen Ovale Closure: A Multicenter, Single-arm, Prospective Study

Provisionally accepted
Lu He Lu He 1Hang Xie Hang Xie 1Yongsheng Gao Yongsheng Gao 2Gangcheng Zhang Gangcheng Zhang 3Qunshan Shen Qunshan Shen 3Minghua Wang Minghua Wang 4Qiguang Wang Qiguang Wang 5Yujiu Wang Yujiu Wang 6Yajuan Du Yajuan Du 1Yushun Zhang Yushun Zhang 1*
  • 1 Department of Structural Cardiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
  • 2 First Affiliated Hospital of Jilin University, Changchun, Jilin Province, China
  • 3 Wuhan Asia Heart Hospital, Wuhan, Hubei Province, China
  • 4 Shandong Provincial Qianfoshan Hospital, Jinan, Shandong Province, China
  • 5 Northern Theater Command General Hospital, Shenyang, Liaoning Province, China
  • 6 Binzhou Medical University Hospital, Binzhou, Shandong Province, China

The final, formatted version of the article will be published soon.

    The 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.This 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).Six 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.A total of 137 patients with a mean age of 38.1±12.4 years who underwent catheterbased 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.CONCLUSIONS: PFO 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.

    Keywords: patent foramen ovale, Biodegradable, Occluder, interventional, therapy

    Received: 15 Jul 2024; Accepted: 14 Jan 2025.

    Copyright: © 2025 He, Xie, Gao, Zhang, Shen, Wang, Wang, Wang, Du and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yushun Zhang, Department of Structural Cardiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.