Amplatzer™ Vascular Plug (AVP)
Designed to provide precise positioning in short landing zones1
- Single lobe, single layer device2
- Platinum marker bands on both ends2
- Select a device that is ~30-50% larger in diameter than the target vessel diameter2
Device Description2:
- Self-expanding device made from a Nitinol wire mesh
- The device is shipped attached to a 135cm nitinol delivery wire in a hoop dispenser
- The device is preloaded in a loader
- No plastic vise is provided
- Sizes ranging from 4mm – 16mm in 2mm increments
Materials2:
- Plug: Nitinol
- Delivery wire: Nitinol
- Marker bands: Platinum
- Micro screw: Stainless steel
References
- Lopera, Jorge E. “The Amplatzer vascular plug: review of evolution and current applications.” Seminars in interventional radiology. Vol. 32. No. 04. Thieme Medical Publishers, 2015.
- Amplatzer™ Vascular Plug and Vascular Plug II - Instructions for Use
MAT-2002814 v1.0
Important Safety Information
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
- Patients allergic to nickel may suffer an allergic reaction to this device.
- This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
- Use on or before the last day of the expiration month that is printed on the product packaging label.
- Do not use this device if the sterile package is open or damaged.
- This device should be used only by physicians who are trained in standard endovascular techniques. The physician should determine which patients are candidates for procedures that use this device.
- Store in a dry place.
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.
MAT-2004315 v3.0
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