Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story
Goldsweig A, Deng Y, Yao X, Desai N, Cohen D, Aronow H, Messé S, Ross J, Lansky A, Savitz S. Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story. Circulation Cardiovascular Quality And Outcomes 2024, 17: e010200. PMID: 38189127, PMCID: PMC10844981, DOI: 10.1161/circoutcomes.123.010200.Peer-Reviewed Original ResearchStroke/systemic embolismTransient ischemia attackPFO closureSystemic embolismIschemia attackRetrospective cohort studyTransient ischemic attackHalf of patientsOptumLabs Data WarehouseCommercial insurance enrolleesRegulatory approvalClinical trial publicationsIschemic attackRecurrent strokeCohort studyPatent foramenUnderwent closureAtrial fibrillationClinical trialsInsurance enrolleesDecompression illnessTrial publicationsOff labelPatientsProcedure volume