The nitinol mesh of an AVP acts as an embolic agent that promotes rapid clot formation. Each AVP creates a physical barrier to blood flow by instigating both the body’s immune response followed by a natural coagulation process.6
The Amplatzer™ Family of Vascular Plugs are indicated for arterial and venous embolization in the peripheral vasculature.
MAT-2002814 v1.0
Intended Use: The AMPLATZER™ Vascular Plug is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
Warnings: The safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.
Precautions:
Handling
MRI Safety Information:
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Device Name | Amplatzer™ Vascular Plug |
Static Magnetic Field Strength (B0) | 1.5 T or 3.0 T |
Maximum Field Spatial Gradient | 19T/m (1900 gnauss/cm) |
RF Excitation | Circularly Polarized (CP) |
RF Transmit Coil Type | Body Coil |
Operating Mode | Normal Operating Mode |
Maximum Whole Body SAR | 2.0W/kg (Normal Operating Mode) |
Maximum Head SAR | N/A |
Scan Duration | 2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning |
MR Image Artifact | The presence of this implant may produce an image artifact. |
Potential Adverse Events: Potential complications include, but are not limited to: death, embolization of the device, hematoma at the site of entry, stroke, or vessel perforation, or embolization of the device.
State of California (USA) Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
MAT-2004315 v2.0
Intended Use: The AMPLATZER™ Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
Warnings: The safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.
Precautions:
MRI Safety Information:
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Device Name | Amplatzer™ Vascular Plug II |
Static Magnetic Field Strength (B0) | 1.5 T or 3.0 T |
Maximum Field Spatial Gradient | 19T/m (1900 gnauss/cm) |
RF Excitation | Circularly Polarized (CP) |
RF Transmit Coil Type | Body Coil |
Operating Mode | Normal Operating Mode |
Maximum Whole Body SAR | 2.0W/kg (Normal Operating Mode) |
Maximum Head SAR | N/A |
Scan Duration | 2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning |
MR Image Artifact | The presence of this implant may produce an image artifact. |
Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.
State of California (USA) Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
MAT-2004317 v2.0
Indications And Usage: The AMPLATZER™ Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
Warnings:
Precautions:
MRI Safety Information:
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Device Name | Amplatzer™ Vascular Plug 4 |
Static Magnetic Field Strength (B0) | 1.5 T or 3.0 T |
Maximum Field Spatial Gradient | 19T/m (1900 gnauss/cm) |
RF Excitation | Circularly Polarized (CP) |
RF Transmit Coil Type | Body Coil |
Operating Mode | Normal Operating Mode |
Maximum Whole Body SAR | 2.0W/kg (Normal Operating Mode) |
Maximum Head SAR | N/A |
Scan Duration | 2.0W/kg whole-body-averaged SAR for 15 minutes of continuous scanning |
MR Image Artifact | The presence of this implant may produce an image artifact. |
Potential Adverse Events: Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:
State of California (USA) Only:
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
MAT-2004318 v2.0
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Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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