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July 31, 2016

American Academy of Neurology Recommends Against PFO Closure for Patients Who Had a Stroke

August 1, 2016—The American Academy of Neurology (AAN) recently announced an updated recommendation stating that catheter-based closure of patent foramen ovale (PFO) should not be routinely recommended for people who have had a stroke and a PFO. The practice advisory, which updates a previous AAN guideline, has been published online by Steven R. Messé, MD, et al in the AAN’s journal, Neurology.

According to AAN, investigators developed the advisory by reviewing all available scientific studies on people with PFO who also had an ischemic stroke. The AAN stated that when the society developed an earlier guideline on this topic in 2004, not enough evidence was available to make a recommendation on whether closing a PFO was effective in reducing stroke risk.

In the AAN announcement, Dr. Messé commented, “Compared with other ways to prevent a second stroke, such as medications to reduce blood clots, the devices used to close a patent foramen ovale have limited evidence to support their use. It’s still uncertain how effective these devices are in reducing stroke risk, and the procedure is associated with uncommon but potentially serious complications.” Dr. Messé is with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania. 

Dr. Messé, who is a Fellow of the AAN, noted that the devices used for PFO closure are not available for routine use in the United States, so the procedure must be done off-label with a device approved for treating a similar heart defect or with another device that does not have strong evidence regarding its use. At the time of publication, the US Food and Drug Administration is currently reviewing the one device that has the best evidence regarding closure, noted the AAN.

The advisory also recommends that aspirin or other antiplatelet drugs be used to prevent blood clots instead of anticoagulant drugs such as warfarin and heparin, unless there is another reason to use blood thinners, such as a person with a history of blood clots in the legs or lungs.

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August 1, 2016

Micro Interventional Devices Receives FDA Clearance for Permaseal Closure Device

August 1, 2016

Micro Interventional Devices Receives FDA Clearance for Permaseal Closure Device


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