(RxWiki News) A new device could reduce the risk of a stroke in those who have had a stroke before.
It's called the Amplatzer PFO Occluder. It was recently approved by the US Food and Drug Administration (FDA).
The new device reportedly reduces the risk of stroke in certain patients. It's approved for those who have had a stroke before — if the stroke is believed to have been caused by a blood clot that traveled to the brain through a small hole in the heart. This small hole is called a patent foramen ovale (PFO).
The Amplatzer PFO Occluder provides a nonsurgical method for doctors to close a PFO. Before a patient receives this device, other causes of stroke have to be ruled out to ensure that closing a PFO would likely reduce the risk of stroke.
The device is inserted through a catheter inserted into a vein in the leg. It is then implanted near the hole in the heart.
Reported side effects include injury to the heart, irregular heart rate, blood clots, bleeding and stroke.
This device is not recommended in some instances. For example, it's not recommended in those with a heart valve infection or other untreated infections, those who have a heart tumor, those who have abnormal connections within the heart, or those who have blood clots or structural abnormalities that could interfere with the device.
Patients should be evaluated by a neurologist and cardiologist to determine whether this device is a viable option, according to the FDA.
St. Jude Medical Inc. manufactures the Amplatzer PFO Occluder.