PFO Occlusion Device Approved in United States

FDA approves St. Jude Medical's Amplatzer PFO Occluder, making it the only device approved in the United States to close the patent foramen ovale.

St. Jude Medical's Amplatzer PFO Occluder for patent foramen ovale (PFO) has received FDA approval, the company announced on October 28. The device, made of two nitinol mesh disks with thin polyester fabric, can now be used in the United States to close the PFO—a congenital hole in the tissue between the heart's left and right atria—in patients who have suffered an ischemic stroke, in order to reduce risk of recurrent stroke.

Although PFO is relatively common, observed in about a quarter of adults, in some cases it is thought to allow paradoxical thromboembolization, enabling a clot to travel to the brain and result in an ischemic stroke, according to an FDA executive summary prepared for the advisory panel on the Amplatzer device. Ischemic stroke patients who also have a PFO are often prescribed antiplatelet or anticoagulant drugs.

FDA's approval makes the Amplatzer PFO Occluder the only approved device in the United State for PFO closure, though other devices have been used off-label for PFO closure.

The Amplatzer PFO Occluder was studied in the Randomized Evaluation of recurrent Stroke comparing PFO closure to Established Current standard of care Treatment (RESPECT) trial. PFO closure with the device, which is delivered percutaneously using a catheter, showed a benefit and cut the risk of recurrent stroke by more than half versus medical management, according to a St. Jude Medical press release.

"This is a well-studied therapy with a strong safety profile," Jeffrey Saver, MD, director of the stroke center at UCLA and professor of neurology at David Geffen School of Medicine, said in the release. "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."

The Circulatory System Device Panel, an FDA advisory committee, considered the device in May 2016 and voted 11-5 that the benefits of the Amplatzer PFO Occluder outweigh the risks. While the panelists voted 15-1 that there was reasonable assurance of the device's safety, the 9-7 vote on its efficacy for the intended use was closer.

"The Amplatzer PFO Occluder procedure takes less than one hour to complete, can be performed with conscious sedation and subsequently provides these patients with over a 50% reduction of risk for having another stroke for many years to come," John Carroll, MD, director of interventional cardiology and the Cardiac and Vascular Center at the University of Colorado Hospital, said in the company release.

Well Fargo senior analyst Larry Biegelsen wrote in an October 28 research note that he expects the FDA approval to contribute "modest incremental revenue" to the company.