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patent foramen ovale (PFO) occlusion device (Amplatzer)

Indications: - prevention of recurrent cryptogenic stroke in patients with patent foramen ovale [1] * incidence of recurrent cryptogenic stroke in patients with patent foramen ovale is low but 50% lower with Amplatzer [1] Adverse effects: - incidence of serious adverse effects 4% - heart injury - atrial fibrillation - blood clots - bleeding - stroke [1]

General

device (medical device)

References

  1. FDA News Release. October 28, 2016 FDA approves new device for prevention of recurrent strokes in certain patients. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm