ArticleJACC. Basic to translational science2025
A Novel Patent Foramen Ovale Occluder With Left Clamp Arms: Preclinical Experiment and First-in-Human Study.
Article in JACC. Basic to translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Traditional occluders for the closure of patent foramen ovale (PFO) may be associated with some potential risks, including device-related thrombus, induction of arrhythmias, residual shunt, and difficulty in puncturing atrial septum. The TriFlower device is a novel transcatheter PFO occluder that features a clamp arm design. The device success rate was 100% (n = 18) in the animal experiment. Endothelialization of the left clamp arms was completed at an early stage (30 days after implantation). The acute procedure success rate in 17 patients was 100%. At 6-month follow-up, the primary efficacy endpoint, an effective PFO closure defined as residual shunt grade 1 or lower, was met in 16 (94.1%) patients and 14 (82.4%) patients had a complete closure. There were no device-related complications. These findings indicate that the TriFlower device is feasible, safe, and effective for transcatheter PFO closure. Its potential advantages include rapid endothelialization and low left atrial interference.
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