ArticleFrontiers in cardiovascular medicine2025
Biodegradable Pansy® occluder for patent foramen ovale closure: a multicenter, single-arm, prospective study.
Article in Frontiers in cardiovascular medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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11 authors.
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Abstract
Background: 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. Objectives: 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). Methods: 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. Results: A 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. 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. Clinical Trial Registration: http://www.chictr.org.cn/index.aspx; identifier (ChiCTR1900024036).
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