PATENT FORAMEN OVALE CLOSURE: CURRENT THERAPEUTIC STRATEGIES WITH PARTICULAR FOCUS ON BIODEGRADABLE AND NON-BIODEGRADABLE OCCLUDERS
DOI:
https://doi.org/10.31435/ijitss.4(52).2026.6369Keywords:
Patent Foramen Ovale, Biodegradable Occluders, Non-biodegradable Occluders, NobleStitch EL, Pansy® Occluder, Cryptogenic StrokeAbstract
Introduction: Percutaneous closure of patent foramen ovale (PFO) has become an established strategy for the secondary prevention of cryptogenic stroke in carefully selected patients. Although conventional non-biodegradable occluders remain the current standard of care, the search for technologies that reduce long-term device-related complications has led to the development of biodegradable occluders and implant-free closure techniques.
Materials and Methods: This narrative review summarizes the current evidence published between 2018 and 2026 regarding transcatheter PFO closure. Clinical trials, observational studies, registries and case reports evaluating conventional metallic occluders, biodegradable devices, and the NobleStitch EL suture-mediated system were analyzed with particular emphasis on procedural efficacy, safety, residual shunting, and long-term clinical outcomes.
Results: Conventional metallic occluders demonstrated excellent long-term efficacy and safety and remain the reference standard for PFO closure. Biodegradable devices showed comparable procedural success while offering the potential advantage of gradual implant resorption and improved biocompatibility. The NobleStitch EL system provides an implant-free alternative, although it is effectiveness depends largely on favourable PFO anatomy and appropriate patient selection.
Conclusions: Emerging technologies broaden the therapeutic options for transcatheter PFO closure. While conventional occluders remain the gold standard, biodegradable devices and suture-mediated techniques represent promising alternatives that warrant further evaluation in large prospective studies with long-term follow-up.
References
Zhang, F., Dong, J., Wei, P., Fang, W., Hu, H., Kong, X., Bai, M., Pan, J., Luo, Z., Zhang, P., Qu, B., Hu, J., Lu, Y., Wang, C., Wang, S., & Pan, X. (2026). Transcatheter closure of patent foramen ovale with a novel biodegradable device: A prospective, multicenter, randomized controlled clinical trial. Circulation, 153(2), 71–81. https://doi.org/10.1161/CIRCULATIONAHA.125.074609
He, L., Xie, H., Gao, Y., Zhang, G., Shen, Q., Wang, M., Wang, Q., Wang, Y., Du, Y., Zhu, X., & Zhang, Y. (2025). Biodegradable Pansy® occluder for patent foramen ovale closure: A multicenter, single-arm, prospective study. Frontiers in Cardiovascular Medicine, 12, Article 1464712. https://doi.org/10.3389/fcvm.2025.1464712
Li, B., Zeng, H., Xie, H., Lan, B., & Zhang, Y. (2026). Safety and efficacy of a novel biodegradable Pansy® occluder compared with traditional non-degradable occluders in the closure of patent foramen ovale. Frontiers in Cardiovascular Medicine, 13, Article 1704287. https://doi.org/10.3389/fcvm.2026.1704287
Witte, L. S., Renkens, M. P. L., Gąsecka, A., El Bouziani, A., De Winter, R. J., Tijssen, J. G. P., Stella, P. R., Leibundgut, G., & Voskuil, M. (2023). Anatomical predictors for suture-based closure of the patent foramen ovale: A multicenter experience. Catheterization and Cardiovascular Interventions, 102(2), 273–280. https://doi.org/10.1002/ccd.30691
Gaetti, G., Beneduce, A., La Fauci, D., Scardoni, A., Chiappa, F., Bellini, L., Franzin, M., Natale, A. M., Marras, P., Ranieri, P., Signorelli, C., Bossi, E., Ferrario, L., Foglia, E., Montorfano, M., & Odone, A. (2022). Suture-mediated patent foramen ovale closure using the NobleStitch EL: Results from a hospital-based health technology assessment. International Journal of Environmental Research and Public Health, 19(13), Article 7863. https://doi.org/10.3390/ijerph19137863
Du, Y., Xie, H., Wang, X., Shao, H., He, L., & Zhang, Y. (2023). Successful percutaneous closure of a large complex patent foramen ovale with an atrial septal aneurysm and two small atrial septal defects using a novel biodegradable occluder. European Heart Journal – Case Reports, 7(2), ytad043. https://doi.org/10.1093/ehjcr/ytad043
Luo, D., Guan, L., Li, H., Lv, J., Hu, H., & Pan, X. (2025). Percutaneous closure of residual shunt after patent foramen ovale closure with a biodegradable occluder. JACC: Case Reports, 30(40), Article 105901. https://doi.org/10.1016/j.jaccas.2025.105901
Gaspardone, A., De Marco, F., Sgueglia, G. A., De Santis, A., Iamele, M., D'Ascoli, E., Tusa, M., Corciu, A., Mullen, M., Nobles, A., Carminati, M., & Bedogni, F. (2018). Novel percutaneous suture-mediated patent foramen ovale closure technique: Early results of the NobleStitch EL Italian Registry. EuroIntervention, 14(3), e272–e279. https://doi.org/10.4244/EIJ-D-18-00023
Beneduce, A., Ancona, M. B., Moroni, F., Ancona, F., Ingallina, G., Melillo, F., Russo, F., Ferri, L. A., Bellini, B., Vella, C., Chieffo, A., Agricola, E., & Montorfano, M. (2022). A systematic transoesophageal echocardiography study of suture-mediated percutaneous patent foramen ovale closure. EuroIntervention, 18(1), 63–67. https://doi.org/10.4244/EIJ-D-21-00242
Zannoni, J., Popolo Rubbio, A., Tusa, M. B., Corciu, A. I., Casenghi, M., Cannone, G., Barletta, M., Stefanini, E., Mantovani, V., Gorla, R., Brambilla, N., Testa, L., Bedogni, F., & De Marco, F. (2022). Mechanisms of ineffective patent foramen ovale closure using the percutaneous suture-mediated NobleStitch system. EuroIntervention, 18(1), 68–70. https://doi.org/10.4244/EIJ-D-21-01021
Randhawa, S., Mehta, J. L., & Dhar, G. (2024). Percutaneous patent foramen ovale closure: Stroke and beyond. Current Cardiology Reviews, 20(3), 77–86. https://doi.org/10.2174/011573403X276984240304044109
Sperlongano, S., Giordano, M., Ciccarelli, G., Bassi, G., Malvezzi Caracciolo D'Aquino, M., Del Giudice, C., Gaio, G., D'Andrea, A., Postolache, A., Cappelli Bigazzi, M., Scognamiglio, G., Sarubbi, B., Russo, M. G., Golino, P., & Lancellotti, P. (2022). Advances in percutaneous patent foramen ovale closure: From the procedure to the echocardiographic guidance. Journal of Clinical Medicine, 11(14), Article 4001. https://doi.org/10.3390/jcm11144001
Shi, F., Sha, L., Li, H., Tang, Y., Huang, L., Liu, H., Li, X., Li, L., Yang, W., Kang, D., & Chen, L. (2023). Recent progress in patent foramen ovale and related neurological diseases: A narrative review. Frontiers in Neurology, 14, Article 1129062. https://doi.org/10.3389/fneur.2023.1129062
Kasner, S. E., Sondergaard, L., Nakum, M., Gomez Montero, M., Hashim, M., & Landaas, E. J. (2024). A matching-adjusted indirect comparison of results from REDUCE and RESPECT: Two randomized trials on patent foramen ovale closure devices to prevent recurrent cryptogenic stroke. Journal of Medical Economics, 27(1), 337–343. https://doi.org/10.1080/13696998.2024.2320604
Apostolos, A., Gregoriou, S., Drakopoulou, M., Trantalis, G., Tsiogka, A., Ktenopoulos, N., Aggeli, K., Stratigos, A., Tsioufis, K., & Toutouzas, K. (2025). Patent foramen ovale closure in patients with and without nickel hypersensitivity: A randomized trial. Circulation: Cardiovascular Interventions, 18(4), e015228. https://doi.org/10.1161/CIRCINTERVENTIONS.125.015228
Kluck, B. W., Gupta, R., & Orzel, A. (2025). Retrospective comparison of device versus suture for patent foramen ovale closure. Heart International, 19(1), 48–56. https://doi.org/10.17925/HI.2025.19.1.4
Kayvanpour, E., Matzeit, E., Kaya, Z., Pleger, S., Bahrmann, A., Reichardt, C., Ringleb, P. A., Frey, N., Meder, B., & Sedaghat-Hamedani, F. (2024). Comparative effectiveness of devices for interventional patent foramen ovale closure: Insights from a 23-year monocentric analysis. Journal of Clinical Medicine, 13(21), Article 6354. https://doi.org/10.3390/jcm13216354
Yapan Emren, Z., Emren, S. V., Karagöz, U., Çelik, A., Özdemir, E., Çitekçi, F. T., Aktürk, S., & Akar, B. (2026). Long-term comparative efficacy and safety of different patent foramen ovale closure devices: Real-world evidence from a 15-year cohort. Journal of Clinical Medicine, 15(9), Article 3429. https://doi.org/10.3390/jcm15093429
Sorysz, D., Glądys, K., Węgiel, M., & Bartuś, S. (2026). Transcatheter closure of interatrial communication using the Cocoon occluder in patients with confirmed nickel hypersensitivity: A long-term observational study. Postępy w Kardiologii Interwencyjnej (Advances in Interventional Cardiology), 22(1), 137–140. https://doi.org/10.5114/aic.2026.160010
Testa, L., Popolo Rubbio, A., Squillace, M., Albano, F., Cesario, V., Casenghi, M., Tarantini, G., Pagnotta, P., Ielasi, A., Popusoi, G., Paloscia, L., Durante, A., Maffeo, D., Meucci, F., Valentini, G., Ussia, G. P., Cioffi, P., Cortese, B., Sangiorgi, G., & Bedogni, F. (2023). Patent foramen ovale occlusion with the Cocoon PFO Occluder: The PROS-IT collaborative project. Frontiers in Cardiovascular Medicine, 9, Article 1064026. https://doi.org/10.3389/fcvm.2022.1064026
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Laura Magdalena Sikorska, Magdalena Aleksandra Boniecka, Dominika Adrianna Ossowska, Julia Anna Kujawa, Klaudia Ścibior, Wiktor Wardyn, Aleksandra Kostańska , Anna Jankowska , Alicja Solecka, Alicja Nierychlewska, Michał Falis

This work is licensed under a Creative Commons Attribution 4.0 International License.
All articles are published in open-access and licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). Hence, authors retain copyright to the content of the articles.
CC BY 4.0 License allows content to be copied, adapted, displayed, distributed, re-published or otherwise re-used for any purpose including for adaptation and commercial use provided the content is attributed.

