The device was available in the US until 2006 under a humanitarian device exemption, but was recalled by St. Jude Medical when the exemption lapsed. (See also: St. Jude Medical Shares Fall Amid Device Failure.)
The Amplatzer patent foramen ovale (PFO) Occluder device is used to prevent strokes by plugging a hole in the heart. It is inserted through a narrow opening in the leg vein.
From there, it advances to the heart, providing a non-surgical method for doctors to close a patent foramen ovale (PFO), which is a small hole in the heart that could allow a blood clot to pass through and reach the brain. A stroke causes damage to the brain by interrupting blood supply.
Amplatzer Plug Did Well in Trial
The FDA has not approved any heart occluder devices specifically indicated to close PFOs in the last decade.
The recent FDA approval for St. Jude Medical is based on a randomized trial involving 980 patients aged 18 and above.
In the study, 499 patients were treated with the Amplatzer PFO Occluder plus blood-thinning therapies against 481 patients who were treated only with blood-thinning therapies.
The study showed there was a 50% reduction in the rate of new strokes in participants using the Amplatzer PFO Occluder plus blood-thinning medications compared to the other group. (For more, see Expert: St. Jude Heart Devices Can Be Hacked.)
Unmet Medical Need
Patients who suffer strokes stemming from a PFO blood clot can benefit from St. Jude Medical's PFO Occluder, which reduces the risk of a recurrent stroke.
Around 25%-30% of U.S. residents have a PFO, but it may not necessarily cause a health problem and may require no treatment.
While the cause of most strokes can be identified, the cause of a small number of stroke cases is unknown. A few such cases are believed to be linked to PFO, which allows the blood clot to reach the brain, causing recurrent strokes.