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Updated: Jun 7, 2026

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence

Published on: December 23, 2022

Fully biodegradable septal defect occluder-a double umbrella design.

Duc Duong-Hong¹, Yong-Dan Tang, Wei Wu

¹School of Materials Science and Engineering, Nanyang Technological University, Singapore.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions

|October 27, 2010

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A new biodegradable "double umbrella" device offers a promising alternative for patent foramen ovale (PFO) closure. This PFO occluder shows feasibility and stability, potentially reducing future complications from nondegradable implants.

Area of Science:

Biomaterials Science
Cardiovascular Surgery
Medical Devices

Background:

Current patent foramen ovale (PFO) closure devices utilize nondegradable materials, posing risks of erosion and future procedural access obstruction.
There is a clinical need for advanced PFO occluders that mitigate long-term complications.

Purpose of the Study:

To evaluate the feasibility and performance of a novel, fully biodegradable "double umbrella" (DU) device for interventional PFO closure.

Main Methods:

The biodegradable DU device, composed of polymers, was implanted in a Yorkshire swine PFO model via thoracotomy.
Device placement and stability were assessed using fluoroscopic imaging and echocardiography over a 1-month period.
In-vitro degradation and post-mortem explantation evaluated device integrity and mechanical strength.

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Main Results:

The biodegradable DU device demonstrated stable positioning without residual shunting in the PFO model.
In-vitro and ex-vivo analyses confirmed the device's integrity and mechanical strength throughout the 1-month study.
Histological examination revealed successful endothelialization of the device after 1 month.

Conclusions:

The fully biodegradable "double umbrella" device is a feasible and effective alternative for patent foramen ovale closure.
This novel PFO occluder shows potential to overcome the limitations associated with current nondegradable devices.