FDA Approves St. Jude Device for Prevention of Recurrent Strokes

The FDA has approved the Amplatzer PFO Occluder device, which reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot passing through a small hole in the heart, called a patent foramen ovale (PFO), and then traveling to the brain.

The Amplatzer PFO Occluder 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 (right atrium) and the top left chamber (left atrium).

The safety and efficacy was assessed study that evaluated 499 participants aged 18 to 60 years old who were treated with the Amplatzer PFO Occluder plus blood-thinning medications compared to 481 participants who were treated with blood-thinning medications alone.

The study found a 50 percent reduction in the rate of new strokes in participants. — Cynthia Jessup