The FDA has approved the Amplatzer Patent Foramen Ovale (PFO) Occluder device, which reduces the risk of stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a PFO. The Amplatzer PFO Occluder is inserted through a catheter that is placed in a leg vein and advanced to the heart. In a randomized study, 499 participants ages 18 to 60 were treated with the Amplatzer PFO Occluder and blood-thinning medications and compared with 481 participants treated with blood-thinning medications alone. There was a 50% reduction in the rate of new strokes in participants using the Amplatzer PFO Occluder and blood-thinning medications, compared with participants taking medications alone. St. Jude Medical, headquartered in Plymouth, Minnesota, markets the Amplatzer PFO Occluder.
—Kimberly Williams