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July 20, 2005

Patent Foramen Ovale Closure DevicesMoving Beyond Equipoise

JAMA. 2005;294(3):366-369. doi:10.1001/jama.294.3.366

The off-label use of patent foraman ovale (PFO) closure devices in patients with a PFO and a first cryptogenic stroke has increased despite a remarkable paucity of supporting clinical data and a lack of US Food and Drug Administration (FDA) approval. Because more than 500 000 patients annually may be candidates for these devices worldwide,1 it is imperative that randomized controlled clinical trials be performed to evaluate the safety and effectiveness of PFO closure devices. An understanding of the relationship between stroke and PFO, the regulatory status of PFO closure devices, the factors hampering enrollment into ongoing randomized trials, and the implications of extensive off-label device use are crucial to the evaluation process for this potentially important therapy.