Key result
Biodegradable and suture-based devices match metallic occluders with ~91% PFO closure rates without permanent implants.
Why the study?
Conventional non-biodegradable PFO occluders are the standard of care for secondary prevention of cryptogenic stroke, but efforts to reduce long-term device-related complications have spurred the development of biodegradable occluders and implant-free closure techniques.
Do biodegradable occluders and suture-mediated closure techniques provide comparable procedural efficacy, safety, and long-term outcomes compared to conventional metallic occluders in patients undergoing transcatheter PFO closure?
Do biodegradable occluders and suture-mediated closure techniques provide comparable procedural efficacy, safety, and long-term outcomes compared to conventional metallic occluders in patients undergoing transcatheter PFO closure?
While conventional metallic occluders remain the gold standard for PFO closure, biodegradable devices and suture-mediated techniques show promising procedural efficacy and offer implant-reducing or implant-free alternatives pending further large prospective evaluation.
May support biodegradable or suture-mediated PFO closure in select patients; leaves open randomized confirmation before practice change.
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.
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Sikorska et al. (2026) conducted a review in Patent foramen ovale (PFO) and cryptogenic stroke. Biodegradable occluders (PDO/PLLA, Pansy, Memosorb, PFO-NBO) and suture-mediated closure (NobleStitch EL) vs. Conventional non-biodegradable metallic occluders (Amplatzer, Gore Cardioform, Gore Helex, Occlutech, Cardia PFO-Star, Cocoon) was evaluated. Biodegradable occluders and the NobleStitch EL system achieve high PFO closure rates comparable to metallic occluders (e.g., 90.63% vs 91.49% at 6 months) while avoiding permanent implants.
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