Experimental Study of the TAI QINGTM Single-Hub Patent Foramen Ovale Occluder.

Aim: To evaluate the feasibility, safety, and effectiveness of the TAI QINGTM single-hub occluder for patent foramen ovale (PFO) in preclinical animal experiments. Methods: Twelve Labrador retrievers were included to establish an animal model of PFO. Under fluoroscopic guidance, the TAI QINGTM single-hub occluder was implanted in the animals with PFO. Three animals were sacrificed at 1, 3, 9 and 12 months post-implantation, respectively, to evaluate the macroscopic anatomical structure and pathological conditions. Results: The TAI QINGTM single-hub occluder was successfully implanted in all 12 Labrador retrievers (100%). No implant-related complications were detected during the operation and follow-up. The occluder remained stable in its implant location. At 1 month post-implantation, the surfaces of both discs was covered with a translucent layer. Over time, the surface of the occluder became covered with an opalescent membrane, and the tissue surrounding the occluder gradually thickened. Histological and electronic microscopy analysis revealed the presence of endothelial cells and collagen fiber deposition in the tissue with increasing implantation time. Furthermore, at 12 months post-implantation, successful re-puncture was performed. Conclusions: The TAI QINGTM single-hub occluder was safe and effective in the animal model. The results support further investigations in large animal models and human clinical trials.