FDA Approves New Device for the Prevention of Strokes

The FDA has approved the Amplatzer PFO Occluder device for the reduction of stroke risk in patients who have previously had a stroke caused by a blood clot passing through a patent foramen ovale (PFO).

PFO are present in roughly 25% to 30% of Americans, and typically cause no health problems. However, patients who have had a cryptogenic stroke and who have PFO may be at increased risk of a second stroke.
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The device is inserted via catheter into the heart, between the left atrium and the right atrium. It had previously been on the market under a humanitarian device exemption, but was withdrawn by the
manufacturer in 2006 after the FDA found that its target population was greater than 4000 patients.

The safety and efficacy of the device was assessed in a randomized study of 499 participants aged 18 to 60 years old treated with the Amplatzer PFO Occluder plus blood-thinning medication, compared with 481 participants treated with blood-thinning medication alone. The researchers found a 50% reduction in the rate of new strokes in participants using the device compared with controls.

Adverse effects include heart injury; irregular or rapid heart rate; blood clots in the heart leg, or lung; bleeding; and stroke.

—Michael Potts

Reference:

FDA. FDA approves new device for prevention of recurrent strokes in certain patients [press release]. October 28, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm. Accessed October 31, 2016.