What is an Amplatzer device used for?

Intended Use The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended to close all types of PFO’s (i.e., classical as well as those with aneurysm of the septum) in patients with a history of stroke or transient ischemic attacks (TIA’s)).

What is an Amplatzer device?

An AMPLATZER PFO Occluder is a device specifically designed to stop blood flow through all types of PFO (Figure 3). The device is placed in the PFO during a catheter-based procedure and will remain permanently implanted. The AMPLATZER PFO Occluder is made from a Nitinol wire mesh with shape memory characteristics.

What is a PFO closure device?

A PFO closure device is moved through the vein to the heart, and specifically to the location of the heart wall defect. Once in the correct location, the PFO closure device is formed so that it straddles each side of the hole.

What is the recovery time for PFO closure?

This is very common about 2 weeks to 6 weeks post closure; usually treatment is NOT required. Prior to discharge, you will be given instructions and a person to contact with questions or concerns.

Does PFO closure prevent stroke?

Both meta-analyses showed that PFO closure prevents recurrent stroke but increases the incidence of AF as compared to medical treatment. PFO closure was associated with a stroke risk reduction of 3.1–3.3% [62, 63] and new-onset AF/flutter risk increment of 3.3% [62].

What is Amplatzer septal occluder made of?

The AMPLATZER® Septal Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. The two discs are linked together by a short connecting waist corresponding to the size of the ASD. In order to increase its closing ability, the discs and the waist are filled with polyester fabric.

Is ASD device MRI compatible?

Conclusion: Non-ferromagnetic occluder models used in this study can safely be imaged with typical cardiac MRI protocols at 1.5 Tesla. The device artifact sizes are small enough to allow anatomical and functional MRI even in the immediate vicinity of the occluders.

How long does ASD surgery take?

The repair will take about 2 hours. The healthcare provider will insert a small, flexible tube (catheter) into an artery in the groin. This tube will have a small device inside it. The healthcare provider will thread the tube through the blood vessel all the way to the atrial septum.

Does a PFO cause fatigue?

Dr Ross Sharpe explains “The presence of a large PFO can be a cause of stroke but can also result in a myriad of clinical symptoms. These symptoms can include a feeling of breathlessness or fatigue performing normal day to day tasks, such as hanging out the washing or going for a jog.

How safe is PFO closure?

In our centre, we found that percutaneous closure of a PFO, which is suggested to be related to a paradoxical embolism, is a safe and effective procedure to prevent the recurrence of paradoxical thromboembolic events, independent of the device used for closure.

Should a small PFO be closed?

“If you have had a stroke without a clear cause and have PFO, it’s reasonable to consider closure,” Dr. Reed says. “And if you know you have a PFO, it’s worthwhile to see a cardiologist. But if you don’t have stroke symptoms and your heart function is good, you won’t need the procedure.”

What do you need to know about Amplatzer plugs?

Tests performed by and data on file at Abbott. Lopera, Jorge E. “The Amplatzer vascular plug: review of evolution and current applications.” Seminars in interventional radiology. Vol. 32. No. 04. Thieme Medical Publishers, 2015. Amplatzer™ Vascular Plug and Vascular Plug II – Instructions for Use Amplatzer™ Vascular Plug 4 – Instructions for Use

Is the Amplatzer PFO occluder an as-treated device?

As-Treated 72% 0.008 Device-in-Place 70% 0.007 CO-14 The AMPLATZER PFO Occluder is intended for percutaneous, transcatheter closure of a PFO to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Can a patient be scanned with an Amplatzer?

Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions: Static magnetic field of 3 tesla or less Spatial gradient magnetic field of 720 G/cm or less

How is an Amplatzer implanted in the LAA?

The device is placed in the LAA during a catheter-based procedure and will remain permanently implanted. The Amplatzer Amulet is made from braided Nitinol wires. Nitinol is a metal with shape memory characteristics, meaning the device will return to its original ‘memorized’ shape even after it is stretched to pass through a catheter.

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