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.
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.
MRI Safety Information:
|A patient with the Amplatzer™ Vascular Plug may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.|
|Device Name||Amplatzer™ Vascular Plug|
|Static Magnetic Field Strength (B0)||1.5 T or 3.0 T|
|Maximum Field Spatial Gradient||19T/m (1900 gauss/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.