Key result
Biodegradable Pansy occluder achieves ~97% complete PFO occlusion at one year with low complication rates.
Why the study?
Next-generation biodegradable PFO closure devices remain challenging to develop, prompting assessment of the safety and efficacy of a novel biodegradable occluder in patients with substantial right-to-left shunt.
Does catheter-based PFO closure with the biodegradable Pansy occluder safely and effectively achieve occlusion in patients with PFO and substantial right-to-left shunt?
Cohort (n=137)
Yes
Does catheter-based PFO closure with the biodegradable Pansy occluder safely and effectively achieve occlusion in patients with PFO and substantial right-to-left shunt?
The novel biodegradable Pansy PFO occluder demonstrated high procedural success and a 97.1% complete occlusion rate at 12 months with a low rate of serious adverse events, suggesting it is a safe and effective alternative to permanent metal occluders.
Supports biodegradable PFO occluder evaluation; leaves open randomized confirmation versus permanent devices.
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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He et al. (2025) conducted a cohort in Patent foramen ovale (PFO) with substantial right-to-left shunt (n=137). Biodegradable Pansy® occluder was evaluated on Complete occlusion rate at 12 months. The biodegradable Pansy® occluder for patent foramen ovale closure achieved a 99.3% procedural success rate and a 97.1% complete occlusion rate at 12 months, with a 2.2% rate of serious adverse events.
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