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AMPLATZER® PFO Occluder for Patent Foramen Ovale Closure

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AGA Medical designed the AMPLATZER® PFO Occluder for closure of PFO defects using a minimally-invasive transcatheter procedure instead of surgery.

Indications, contraindications, warnings, precautions and instructions for use can be found in the Instructions For Use supplied with each device.

AMPLATZER® PFO Occluder

AMPLATZER® PFO Occluders for heart defect repair utilize the shape memory of Nitinol, a wire made from an alloy of nickel and titanium. Each Occluder is made of a Nitinol wire mesh that is shaped into two flat discs and a middle, or “waist” to pull the discs up to the septum wall. Polyester fabric inserts help close the hole and provide a foundation for growth of tissue over the occluder after placement.

The placement procedure typically takes place in a special room called a catheterization laboratory ( cath lab ) where many minimally invasive, non-surgical procedures are performed. The PFO Occluder is delivered to the correct place in the heart through a catheter, a small plastic tube used to access the heart. The physician deploys the occluder to expand each disc on either side of the defect, closing off the hole.

Most people who experience PFO closure with the AMPLATZER PFO Occluder are able to return home the same or next day.

The AMPLATZER PFO Occluder is in Investigational Trials in the United States for treatment of cryptogenic stroke and migraine. Learn more about PFO Clinical Trials

The PFO Occluder is presently available in the EU and many other countries worldwide, and is also in clinical studies for treatment of migraine in Europe, the UK and Canada. Learn more about PFO Clinical Trials.