Ten years after it was voluntarily from the market, FDA has approved St. Jude's Amplatzer PFO Occluder device for reducing recurrent stroke risk in certain patients.
FDA and St. Jude Medical on October 28 announced approval of the company's Amplatzer PFO Occluder to reduce recurrent stroke risk in patients believed to have had previously had a stroke because a blood clot passed through a small hole in their heart and passed onto their brain.
About a quarter to a third of Americans have patent foramen ovale (PFO), a small in the wall between the right and left upper chambers of the heart that never closed after birth. It generally causes no health problems. But it seems that in cases where a stroke had an unknown cause, risk of a second stroke is greater when there is a PFO.
The Amplatzer PFO Occluder plugs the hole through a catheter-based procedure. It was previously available in the U.S. under a humanitarian device exemption, but was voluntarily withdrawn from the market after FDA concluded the patient population was more than 4000.
“Given what we know about the devastating effects of ischemic stroke, the Amplatzer PFO Occluder is a compelling treatment option in preventing another stroke for patients with a history of cryptogenic stroke and a PFO who are otherwise young and healthy," Jeffrey L. Saver, MD, director of the stroke center at UCLA and professor of neurology at David Geffen School of Medicine, said in a St. Jude Medical news release.
In a randomized study involving 499 people 18 to 60 years old, rate of new strokes was actually low in both groups, but there was a 50% reduction in new strokes among people with both the Amplatzer PFO Occluder versus only blood-thinning medications. The results were enough for FDA to conclude "reasonable assurance of safety and effectiveness."
Given the adverse events associated with the device or the implantation procedure—including injury to the heart, irregular and/or rapid heart rate (atrial fibrillation), blood clots in the heart, leg or lung, bleeding and stroke—device adoption could be below 50%, with a less than $200 million in average annual U.S. sales, according to EP Vantage, which cited analysis from Wells Fargo.