The Spectrum of PFO Closure Devices | 合法醫療器材資訊網

TheAmplatzeroccluderistheonlydevicethathasFDAapprovalforPFOclosureinthecontextofcryptogenicstroke.Itismadeoftwonitinolwovendiscswith ...

Patent foramen ovale (PFO) is a tunnel-like passage in the interatrial septum formed by failure of postnatal fusion of the septum primum and secundum. Persistent PFO is estimated to occur in approximately 20% to 25% of the adult population. Despite its high prevalence, the clinical significance of a persistent PFO remains an area of intense debate. Over the years, PFO has been implicated in multiple clinical conditions for which closure has been proposed, including cryptogenic stroke,1 migraine,2 decompression sickness,3 platypnea-orthodeoxia syndrome,3 and paradoxical cardiosystemic embolization.3

Nonetheless, the recently published multicenter RESPECT trial, which randomly assigned patients with a proven PFO and ischemic stroke, transient ischemic attack, or systemic thromboembolism to PFO closure or medical therapy, is the only study that has conclusively demonstrated a medium-term clinical ben...