Open Access

A Novel Transcatheter Suture Closure System for Patent Foramen Ovale: An Experimental Study in Swine

Su Ye¹, Luxi Guan¹, Dong Luo¹, Fengwen Zhang¹, Jianhua Lv¹, Qizong Xie², Qiao Huang², Haiming Wu², Haibo Hu^1,*, Xiangbing Pan^1,*

1 Center of Structural Heart Disease, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China
2 Halocinch Medical Technology (Shenzhen) Co., Ltd., Yifenghua Innovation Industrial Park, Dalang Street, Longhua District, Shenzhen, 518109, China

* Corresponding Authors: Haibo Hu. Email: ; Xiangbing Pan. Email:

(This article belongs to the Special Issue: Novel Methods and Techniques for the Management of Congenital Heart Disease)

Congenital Heart Disease 2025, 20(2), 181-193. https://doi.org/10.32604/chd.2025.063297

Received 10 January 2025; Accepted 22 April 2025; Issue published 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 thrombus formation. Postoperative ultrasound demonstrated stable suture and staple positions throughout follow-up, with no evidence of suture breakage, displacement, or thrombus. Staples were clearly visualized under ultrasound imaging. Both the atrial septal defect orifice diameter and residual septal shunt flow velocity decreased significantly during the observation period. Histopathological analysis revealed partially organized thrombi at the implant head and fibrous connective tissue encapsulation with localized inflammatory cell infiltration surrounding the polymer material. Conclusions: The transcatheter suture closure system (HaloStitch^®) demonstrated feasibility, safety, and biocompatibility for PFO closure in a swine model, supporting its potential for clinical translation.

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