Low-profile embolization compatible with 0.038" guide wire compatible diagnostic catheters1 that reach distal vasculature through tortuous anatomy.2
A - Vascular Plug Diameter
B - Unconstrained Length
Amplatzer™ Vascular Plug 4
|Vessel Size||Device Dimensions||Diagnostic Catheter Requirements|
|Treatable Vessel Diameter Range||Model/Reorder Number||Vascular Plug Diameter (A)||Unconstrained Length (B)||Requirements for diagnostic catheters||Maximum Diagnostic Catheter Length|
|2.5 mm-3.0 mm||9-AVP038-004||4 mm||10.0 mm||0.038" Guidewire-Compatible Diagnostic Catheter||≤ 125 cm|
|3.5 mm-4.0 mm||9-AVP038-005||5 mm||10.5 mm||0.038" Guidewire-Compatible Diagnostic Catheter||≤ 125 cm|
|4.0 mm-4.5 mm||9-AVP038-006||6 mm||11.0 mm||0.038" Guidewire-Compatible Diagnostic Catheter||≤ 125 cm|
|4.5 mm-5.5 mm||9-AVP038-007||7 mm||12.5 mm||0.038" Guidewire-Compatible Diagnostic Catheter||≤ 125 cm|
|5.5 mm-6.0 mm||9-AVP038-008||8 mm||13.5 mm||0.038" Guidewire-Compatible Diagnostic Catheter||≤ 125 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 4 is delivered utilizing a Diagnostic Catheter meeting the minimum internal diameter requirements above.
**The Amplatzer™ Vascular Plug 4 has been tested for compatibility with the following diagnostic catheters and corresponding lengths:
5F Dx Catheters: Boston Scientific IMAGER‡ II (100 cm or less) and Merit Medical Impress‡ (125 cm or less)
4F Dx Catheters: Cordis‡ TEMPO‡ or TEMPO‡ AQUA‡ (100 cm or less)
***Each Amplatzer™ Vascular Plug 4 comes pre-loaded and packaged on an 0.038" x 155cm-long PTFE-coated delivery wire.
Indications And Usage: The AMPLATZER™ Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
MRI Safety Information:
|A patient with the Amplatzer™ Vascular Plug 4 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 4|
|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 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.