Idiomas disponibles
Idiomas disponibles
Amplatzer™ Talisman™ Patent Foramen Ovale Occluder
EN: Instructions for Use
CAUTION: Read all instructions carefully. Failure to follow these instructions, warnings, and precautions may
lead to patient injury or device damage.
Device Description and Purpose
The Amplatzer™ Talisman™ PFO 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 that allows free motion of each disc. The occluder has radiopaque
marker bands on its distal and proximal ends, and also contains an end screw on the proximal end to facilitate delivery and
deployment. The device is sterilized with ethylene oxide.
Figure 1. Amplatzer™ Talisman™ PFO Occluder
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Right atrial disc
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Left atrial disc
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Connecting waist
Appendix A: Supplemental Information contains additional information about the occluder, delivery sheath, and dilator:
• Table 1 contains the device and delivery sheath dimensions.
• Figure 1 shows the Amplatzer™ Talisman™ PFO Occluder pre-attached to the Amplatzer™ Trevisio™ delivery cable.
The illustration has call-outs for the following components:
Delivery cable
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Hemostasis valve
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Extension tube with three-way stopcock
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Plastic vise
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PFO occluder
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Distal cable attached to the occluder
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Loader
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• Figure 2 shows intracardiac echocardiography (ICE) images.
• Figure 3 shows transesophageal echocardiography (TEE) images.
Intended Use
The Amplatzer™ Talisman™ PFO Occluder is a percutaneous, transcatheter occlusion device intended to close a patent
foramen ovale.
Indication for Use
The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale
(PFO) to reduce the risk of recurrent ischemic stroke in patients who have had an ischemic stroke due to a presumed
paradoxical embolism.
Performance Characteristics
The Amplatzer™ Talisman™ PFO Occluder consists of the following:
• PFO occluder
• Amplatzer™ Trevisio™ delivery cable
• Loader
• Hemostasis valve with extension tube and three-way stopcock
• Plastic vise
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