Biodegradable devices for transcatheter patent foramen ovale closure: current evidence and future directions

Biodegradable devices for transcatheter patent foramen ovale (PFO) closure offer an alternative to nitinol occluders by enabling effective closure without leaving a permanent implant. Metallic devices have excellent success but can cause inflammation, device-related complications, and challenges for future transseptal procedures. Biodegradable platforms, including collagen matrices and fully polymeric frames, aim to provide early stability followed by controlled resorption and tissue replacement.

Preclinical studies show rapid endothelialization, favorable biocompatibility, and organized tissue ingrowth during degradation. Early human experience with BioSTAR, Mallow, ABSNow, and Carag devices demonstrates high procedural success, good short-term occlusion, and imaging evidence of resorption. Recent multicenter studies and a randomized trial report non-inferior closure rates compared with nitinol devices and near-complete resorption within 12 to 24 months. Device-related issues such as transient thrombus, residual shunting, and structural limitations indicate the need for tailored antithrombotic therapy and careful follow-up.

Biodegradable occluders may be valuable for younger patients or those who may need future left-sided interventions. Early results are promising, but long-term clinical data are limited, and definitive evidence of reduced late complications or better stroke-prevention outcomes is still lacking. Further optimization of materials, standardized imaging endpoints, and long-term comparative studies remain priorities.