Fully biodegradable septal defect occluder-a double umbrella design.

Current percutaneous devices for septal defect treatment are made of nondegradable metallic and synthetic fabric materials. These devices are not ideal due to risks of future complications from device erosions and potential obstructed access for future transseptal procedures. The biodegradable double umbrella device was made of fully biodegradable polymers, featured with two discs connected with a stretchable stem. The devices were inserted across the PFO model created on Yorkshire swines through a short sheath by open thoracotomy. Fluoroscopic imaging and echocardiography obtained during the 1-month follow-up study period showed that the devices were in stable position with no shunt. The in-vitro degradation study and post-mortem explantation confirmed that the devices have good integrity and mechanical strength during the 1-month trial. Furthermore, the devices appeared to be well endothelialized after 1 month. These results showed clearly that it is feasible to replace the current nondegradable devices with the new generation biodegradable PFO occluders. This work studied and proved the feasibility of interventional closure of patent foramen ovale (PFO) with a fully biodegradable device, that we call the "double umbrella" (DU) for its symbolic design.