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.
Maisel WH, Laskey WK. Patent Foramen Ovale Closure DevicesMoving Beyond Equipoise. JAMA. 2005;294(3):366–369. doi:10.1001/jama.294.3.366
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