FDA Approves First PFO Occluder From St. Jude

The Food and Drug Administration (FDA) approved on Friday, Minnesota-based St. Jude Medical Amplatzer PFO occluder, qui est intended to reduce the risk of stroke in some patients who previously had a stroke.

The device - qui was sold more than a decade under a Humanitarian Device Exemption (HDE) target ago was voluntarily withdrawn by St. Jude in 2006 after the FDA concluded that her goal was greater than 4,000 patients population - is specifically for Tal patients who previously had a stroke that is believed to be caused by a blood clot passing through a small hole in the heart, expired called patent foramen ovale (PFO), and then traveled to the brain.

Since 2006 (when the device was withdrawn from the market), this is the first occluder heart FDA approved It is especially indicated to close the PFO to reduce the risk of a recurrent stroke in patients with cryptogenic stroke before, qui is a type of stroke When medical tests can not identify the cause.

"The Amplatzer PFO occluder provides a non-surgical method for physicians to close a PFO," said Bram Zuckerman, M. D., director of the Division of Cardiovascular Devices at the FDA Center for Devices and Radiological Health. "Purpose as the device labeling clearly states, patients should be carefully evaluated by a neurologist and a cardiologist to rule out other causes known of stroke and help ensure that PFO closure with the device will likely help reduce the risk of a recurrent stroke . "

How does it work

The Amplatzer PFO occluder is inserted through a catheter placed in a leg vein and advanced into the heart. Here it is implanted near the hole in his heart between top right chamber (right atrium) and the left upper chamber (left atrium).

FDA said that the duties of devices can not be used in patients with an infection of the heart valves other infections untreated gold, gold heart tumor or blood clot in the implant site. The device is contraindicated in patients with other abnormal connection between heart chambers them or in which the anatomy or blood clots could interfere with the ability to move the catheter.

Assays for approval

FDA concluded device that demonstrated a reasonable assurance of safety and effectiveness after a Assessed randomized 499 participants aged 18 to 60 years who were treated with an Amplatzer PFO anticoagulants more drugs and compared with 481 participants who were treated with blood anticoagulant drugs.

While the rate of new beats in both treatment groups was very low, the FDA Said, the study found a 50% reduction in the rate of new stroke in participants who use the PFO Amplatzer occluder more drugs that thin the blood compared to those only take blood-thinning medications.