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# FDA OKs St. Jude Stroke Reducing Device
- URL: https://www.fdaweb.com/fda-oks-st-jude-stroke-reducing-device/
- Published: 2016-10-28T12:00:00.000Z
- Updated: 2026-09-14T21:43:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137202

FDA has approved a St. Jude Medical PMA for the Amplatzer PFO Occluder device to reduce the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart (patent foramen ovale) and then traveled to the brain. About 25% to 30% of Americans have a patent foramen ovale (PFO), which typically causes no health problems and does not require treatment, according to an agency [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm?ref=fdaweb.com).  

“However, in some patients, medical tests cannot identify the cause of the stroke, which is referred to as a cryptogenic stroke,” FDA says. “In a small percentage of these patients, it is believed that the PFO provided a path for a blood clot to travel to the brain where it blocked a blood vessel resulting in a stroke. Patients with a cryptogenic stroke and a PFO may be at an increased risk of having a second stroke.”

The device is inserted through a catheter that is placed in a leg vein and advanced to the heart. It is then implanted close to the hole in the heart between the top right chamber and the top left chamber. Approval was based on data from 499 patients aged 18 to 60 years old who were treated with Amplatzer plus blood-thinning medications compared to 481 participants who were treated with blood-thinning medications alone. “While the rate of new strokes in both treatment groups was very low, the study found a 50% reduction in the rate of new strokes in participants using the Amplatzer PFO Occluder plus blood-thinning medications compared to participants taking only blood-thinning medications,” FDA says.