Su Ye1, Luxi Guan1, Dong Luo1, Fengwen Zhang1, Jianhua Lv1, Qizong Xie2, Qiao Huang2, Haiming Wu2, Haibo Hu1,*, Xiangbing Pan1,*
Congenital Heart Disease, Vol.20, No.2, pp. 181-193, 2025, DOI:10.32604/chd.2025.063297
- 30 April 2025
Abstract Objectives: This study aimed to evaluate the feasibility, safety, and efficacy of a novel transcatheter suture closure system (HaloStitch®) for patent foramen ovale (PFO) closure in a swine model. Methods: Thirteen swine underwent experimental PFO model creation. All animals received implantation of the transcatheter suture closure system to evaluate procedural success. Comprehensive follow-up over six months included serial ultrasound imaging, histopathological analysis, and gross anatomical examination of cardiac specimens. Results: Successful HaloStitch® device implantation was achieved in 11 of 13 swine. Gross anatomical examination confirmed secure positioning of all sutures in the atrial septum, with no redundancy or… More >