Amplatzer™ Vascular Plug II (AVP II)
Sizing and Specs1
Rapid embolization2 and can adjust to variable landing zones3
A - Vascular Plug Diameter
B - Unconstrained Length
Sizing and Device Selection
Amplatzer™ Vascular Plug II
| 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** |
| 2.0 mm-2.5 mm | 9-AVP2-003 | 3mm | 6mm | 1.42-1.70 mm / 0.056-0.067 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 2.5 mm-3.0 mm | 9-AVP2-004 | 4mm | 6mm | 1.42-2.50 mm / 0.056-0.098 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 4.0 mm-4.5 mm | 9-AVP2-006 | 6mm | 6mm | 1.42-2.50 mm / 0.056-0.098 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 5.5 mm-6.0 mm | 9-AVP2-008 | 8mm | 7mm | 1.42-2.69 mm / 0.056-0.106 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 6.5 mm-7.5 mm | 9-AVP2-010 | 10mm | 7mm | 1.78-2.69 mm / 0.070-0.106 in | ≥5 F | ≥6 F | ≤ 100 cm | |
| 8.0 mm-9.0 mm | 9-AVP2-012 | 12mm | 9mm | 1.78-2.69 mm / 0.070-0.106 in | ≥5 F | ≥6 F | ≤ 100 cm | |
| 9.5 mm-11.0 mm | 9-AVP2-014 | 14mm | 10mm | 2.18-2.69 mm / 0.086-0.106 in | ≥6 F | ≥8 F | ≤ 100 cm | |
| 10.5 mm-12.5 mm | 9-AVP2-016 | 16mm | 12mm | 2.18-2.69 mm / 0.086-0.106 in | ≥6 F | ≥8 F | ≤ 100 cm | |
| 12.0 mm-14.0 mm | 9-AVP2-018 | 18mm | 14mm | 2.49-2.69 mm / 0.098-0.106 in | ≥7 F | ≥9 F | ≤ 100 cm | |
| 13.5 mm-15.5 mm | 9-AVP2-020 | 20mm | 16mm | 2.49-2.69 mm / 0.098-0.106 in | ≥7 F | ≥9 F | ≤ 100 cm | |
| 14.5 mm-17.0 mm | 9-AVP2-022 | 22mm | 18mm | 2.49-2.69 mm / 0.098-0.106 in | ≥7 F | ≥9 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 II is delivered utilizing either a sheath or guide catheter meeting the minimum internal diameter requirements above.
**Each Amplatzer™ Vascular Plug II comes pre-loaded on a 135cm nitinol delivery wire.
References
- Amplatzer™ Vascular Plug and Vascular Plug II - Instructions for Use
- Pech M, Kraetsch A, Winers G, et al., Embolization of the Gastroduodenal Artery Before Selective Internal Radiotherapy: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils with the Amplatzer Vascular Plug II. CVIR 2009(32)3:455-61.
- AVP II is available in 8 unconstrained lengths ranging from 6 -18 mm.
MAT-2002814 v1.0
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:
- 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.
- Patients with nickel allergy can experience an allergic reaction to this device.
- 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.
- The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
- Store in a dry place.
MRI Safety Information:
 A patient with the Amplatzer™ Vascular Plug II 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 II |
| 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, 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 v3.0
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