Designed to provide precise positioning in short landing zones2
A - Vascular Plug Diameter
B - Unconstrained Length
Amplatzer™ Vascular Plug
| Vessel Size | Device Dimensions | Delivery Catheter Requirements* | ||||||
|---|---|---|---|---|---|---|---|---|
| Treatable Vessel Diameter Range† | Model/Reorder Number | Vascular Plug Diameter (A) | Unconstrained Length (B) | Minimum and Maximum Internal Diameter | Minimum Sheath Size | or | Minimum Guide Catheter Size | Maximum Delivery Catheter Length** |
| 2.5 mm-3.0 mm | 9-PLUG-004 | 4mm | 7mm | ≥1.42 mm / ≥0.056 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 4.0 mm-4.5 mm | 9-PLUG-006 | 6mm | 7mm | ≥1.42 mm / ≥0.056 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 5.5 mm-6.0 mm | 9-PLUG-008 | 8mm | 7mm | ≥1.42 mm / ≥0.056 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 6.5 mm-7.5 mm | 9-PLUG-010 | 10mm | 7mm | ≥1.68 mm / ≥0.066 in | ≥5 F | ≥6 F | ≤ 100 cm | |
| 8.0 mm-9.0 mm | 9-PLUG-012 | 12mm | 8mm | ≥1.68 mm / ≥0.066 in | ≥5 F | ≥6 F | ≤ 100 cm | |
| 9.5 mm-11.0 mm | 9-PLUG-014 | 14mm | 8mm | ≥2.21 mm / ≥0.087 in | ≥6 F | ≥8 F | ≤ 100 cm | |
| 10.5 mm-12.5 mm | 9-PLUG-016 | 16mm | 8mm | ≥2.21 mm / ≥0.087 in | ≥6 F | ≥8 F | ≤ 100 cm | |
†Treatable vessel diameter range based on the devices Instructions for Use to select a plug that is oversized by approximately 30-50% at the occlusion site.
*The Amplatzer™ Vascular Plug is delivered utilizing either a sheath or guide catheter meeting the minimum internal diameter requirements above.
**Each Amplatzer™ Vascular Plug comes pre-loaded on a 135cm nitinol delivery wire.
MAT-2002814 v1.0
AMPLATZER™ Vascular Plug
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
Through non-clinical testing, the AMPLATZER™ Vascular Plug has been shown to be MR safe at field strengths of 3.0 Tesla or less with a maximum whole body averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 Tesla and 5.57 W/kg at 5.0 Tesla for a 20 minute exposure to a B1 of 118 μT. The AMPLATZER™ Vascular Plug should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 Tesla.
In this testing, the device produced a temperature rise of 1.1°C at 1.5 Tesla and 1.6°C at 5.0 Tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.
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 and its packaging have been sterilized with ethylene oxide. The packaging may expose you to ethylene oxide, a chemical known to the State of California to cause cancer or birth defects or other reproductive harm.
AMPLATZER™ Vascular Plug II
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:
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:
During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.
AMPLATZER™ Vascular Plug 4
Indications And Usage: The AMPLATZER™ Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
Warnings:
Precautions:
Non-clinical testing has demonstrated that the AMPLATZER™ Vascular Plug 4 device is MR Conditional. It can be scanned safely under the following conditions:
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.
Potential Adverse Events: Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:
MAT-2103601 v1.0
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Precautions
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