The nitinol mesh of an AVP acts as an embolic agent that promotes clot formation. Each AVP creates a physical barrier to blood flow by instigating both the body’s immune response followed by a natural coagulation process.6
The AmplatzerTM Vascular Plug 4 is intended for therapeutic embolisation to reduce or obstruct blood flow.
The AmplatzerTM Family of Vascular Plugs are indicated for arterial and venous embolisation in the peripheral vasculature.
Designed to provide precise positioning in short landing zones6
A: Vascular plug diameter
B: Unconstrained length
| 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 | 4 mm | 7 mm | ≥1.42 mm / ≥0.056 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 4.0 mm- 4.5 mm | 9-PLUG-006 | 6 mm | 7 mm | ≥1.42 mm / ≥0.056 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 5.5 mm- 6.0 mm | 9-PLUG-008 | 8 mm | 7 mm | ≥1.42 mm / ≥0.056 in | ≥4 F | ≥5 F | ≤ 100 cm | |
| 6.5 mm- 7.5 mm | 9-PLUG-010 | 10 mm | 7 mm | ≥1.68 mm / ≥0.066 in | ≥5 F | ≥6 F | ≤ 100 cm | |
| 8.0 mm- 9.0 mm | 9-PLUG-012 | 12 mm | 8 mm | ≥1.68 mm / ≥0.066 in | ≥5 F | ≥6 F | ≤ 100 cm | |
| 9.5 mm- 11.0 mm | 9-PLUG-014 | 14 mm | 8 mm | ≥2.21 mm / ≥0.087 in | ≥6 F | ≥8 F | ≤ 100 cm | |
| 10.5 mm- 12.5 mm | 9-PLUG-016 | 16 mm | 8 mm | ≥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 utilising either a sheath or guide catheter meeting the minimum internal diameter requirements above.
**Each Amplatzer™ Vascular Plug comes pre-loaded on a 135 cm nitinol delivery wire.
Note: This section should not be used in place of the Instructions for Use. This section only provides an overview of the procedure. Refer to the Instructions for Use for additional information.8
Access the vessel and perform an angiogram using standard technique to measure the diameter of the vessel at the desired occlusion site.
Select a vascular plug with a diameter approximately 30-50% larger than the vessel diameter at the occlusion site. Ensure that the occlusion site has sufficient length so the deployed device length will not obstruct other vessels or anatomical structures.
| 1 | Flush hoop dispenser and loader with sterile saline until fluid exits the distal tip to purge air from the loader. |
| 2 | Remove device (in loader) and delivery wire from the hoop dispenser. |
| 3 | Select a delivery catheter with an internal diameter that will accommodate the selected device. The original access catheter may be used if the internal diameter is sufficient for the selected device. Prepare the catheter for use (according to the manufacturer’s instructions for use). |
| 4 | Advance the delivery catheter over the guidewire until the distal tip of the catheter is at the distal edge of the occlusion site (according to the manufacturer’s instructions for use). |
| 5 | Remove the guidewire. |
| 6 | Insert loader into the delivery catheter through a Y-connector or hemostasis valve. |
| 7 | Allow blood backflow or aspirate the system to ensure air is purged from the catheter and loader. |
| 8 | Do not over tighten Y-connector to avoid damaging loader. |
| 9 | Advance the delivery wire to advance the device to the distal end of the delivery catheter. Do not twist or rotate the delivery wire during advancement to ensure device does not prematurely detach. |
| 10 | Hold delivery wire in place and slowly retract the delivery catheter to deploy the device at the occlusion site. |
| 11 | Verify position of the device using the radiopaque marker bands. ~ If unsatisfactory, stabilise the wire and re-advance the delivery catheter until the device is completely within the catheter. Reposition and deploy, or remove the device from the patient. ~ If satisfactory, attach the plastic visea to the wire and rotate the delivery wire counterclockwise until it separates from the device. |
| 12 | Remove delivery catheter and wire from the patient. |
Designed for rapid embolisation2 and can adjust to variable landing zones9
A: Vascular plug diameter
B: Unconstrained length
| 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 | 3 mm | 6 mm | 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 | 4 mm | 6 mm | 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 | 6 mm | 6 mm | 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 | 8 mm | 7 mm | 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 | 10 mm | 7 mm | 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 | 12 mm | 9 mm | 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 | 14 mm | 10 mm | 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 | 16 mm | 12 mm | 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 | 18 mm | 14 mm | 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 | 20 mm | 16 mm | 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 | 22 mm | 18 mm | 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 AmplatzerTM Vascular Plug II is delivered utilising either a sheath or guide catheter meeting the minimum internal diameter requirements above.
**Each AmplatzerTM Vascular Plug II comes pre-loaded on a 135 cm nitinol delivery wire.
Note: This section should not be used in place of the Instructions for Use. This section only provides an overview of the procedure. Refer to the Instructions for Use for additional information.10
Access the vessel and perform an angiogram using standard technique to measure the diameter of the vessel at the desired occlusion site.
Select a vascular plug with a diameter approximately 30-50% larger than the vessel diameter at the occlusion site. Ensure that the occlusion site has sufficient length so the deployed device length will not obstruct other vessels or anatomical structures.
| 1 | Flush hoop dispenser and loader with sterile saline until fluid exits the distal tip to purge air from the loader. |
| 2 | Remove device (in loader) and delivery wire from the hoop dispenser. |
| 3 | Select a delivery catheter with an internal diameter that will accommodate the selected device. The original access catheter may be used if the internal diameter is sufficient for the selected device. Prepare the catheter for use (according to the manufacturer’s instructions for use). |
| 4 | Advance the delivery catheter over the guidewire until the distal tip of the catheter is at the distal edge of the occlusion site (according to the manufacturer’s instructions for use). |
| 5 | Remove the guidewire. |
| 6 | Insert loader into the delivery catheter through a Y-connector or hemostasis valve. |
| 7 | Allow blood backflow or aspirate the system to ensure air is purged from the catheter and loader. |
| 8 | Do not over tighten Y-connector to avoid damaging loader. |
| 9 | Advance the delivery wire to advance the device to the distal end of the delivery catheter. Do not twist or rotate the delivery wire during advancement to ensure device does not prematurely detach. |
| 10 | Hold delivery wire in place and slowly retract the delivery catheter to deploy the device at the occlusion site. |
| 11 | Verify position of the device using the radiopaque marker bands. ~ If unsatisfactory, stabilise the wire and re-advance the delivery catheter until the device is completely within the catheter. Reposition and deploy, or remove the device from the patient. ~ If satisfactory, attach the plastic visea to the wire and rotate the delivery wire counterclockwise until it separates from the device. |
| 12 | Remove delivery catheter and wire from the patient. |
Low-profile embolisation compatible with 0.038” guide wire-compatible diagnostic catheters7 that are designed to reach distal vasculature through tortuous anatomy.6
A: Vascular plug diameter
B: Unconstrained length
| 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 AmplatzerTM Vascular Plug 4 is delivered utilising a Diagnostic Catheter meeting the minimum internal diameter requirements above.
**The AmplatzerTM 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 AmplatzerTM Vascular Plug 4 comes pre-loaded and packaged on an 0.038" x 155cm-long PTFE-coated delivery wire.
Note: This section should not be used in place of the Instructions for Use. This section only provides an overview of the procedure. Refer to the Instructions for Use for additional information.7
Access the vessel and perform an angiogram using standard technique to measure the diameter of the vessel at the desired occlusion site.
Select a vascular plug with a diameter approximately 30-50% larger than the vessel diameter at the occlusion site. Ensure that the occlusion site has sufficient length so the deployed device length will not obstruct other vessels or anatomical structures.
| 1 | a) Flush with sterile saline through the stop cock until fluid exits the distal tip to purge air from the loader. NOTE: If the AVP 4 is inadvertently deployed before use, follow these additional steps prior to use: b) grasp the spring-loaded tapered loader tubing and the rotating luer in one hand and retract the delivery wire with the other hand. c) Continue to retract the delivery wire until both the single white marker and the double white markers on the delivery wire are visible. Make sure the device is fully retracted into the loader. d) Reflush the device if necessary. |
| 2 | Remove device (in loader) and delivery wire from the hoop dispenser. |
| 3 | Select a delivery catheter with an internal diameter that will accommodate the selected device. The original access catheter may be used if the internal diameter is sufficient for the selected device. Prepare the catheter for use (according to the manufacturer’s instructions for use). |
| 4 | Advance the delivery catheter over the guidewire until the distal tip of the catheter is at the distal edge of the occlusion site (according to the manufacturer’s instructions for use). |
| 5 | Remove the guidewire. |
| 6 | Insert the tapered tip of the loader into the hub of the 0.038 inch guidewire compatible diagnostic catheter. NOTE: Do not connect the luer through a stopcock, hemostasis valve, Y-connector or other valve. This will result in damage to the loader. |
| 7 | Grasp the rotating luer and press the luer to the hub of the catheter and rotate clockwise to ensure full engagement of the loader to the catheter hub. |
| 8 | Advance the delivery wire until the double white marker is as the hemostasis valve. |
| 9 | Hold delivery wire in place and slowly retract the delivery catheter to deploy the device at the occlusion site. |
| 10 | Verify position of the device using the radiopaque marker bands. ~ If unsatisfactory, stabilise the wire and re-advance the delivery catheter until the device is completely within the catheter. Reposition and deploy, or remove the device from the patient. ~ If satisfactory, attach the plastic vise to the wire and rotate the delivery wire counterclockwise until it separates from the device. |
| 11 | Remove delivery catheter and wire from the patient. |
References:
1. Hart JL, et al. Eur Radiol; 2010. 20(11): 2663-70.
2. Pech M, et al. Cardiovasc Intervent Radiol; 2009. 32(3): 455-61.
3. Abbott, Testing data on file.
4. Kucukay F, et al. J Vasc Interv Radiol; 2014. 25(9): 1327-32.
5. Vandy F, et al. J Vasc Surg; 2008. 48(5): 1121-4.
6. Lopera JE, Semin Intervent Radiol; 2015. 32(4): 356-69.
7. Abbott, AmplatzerTM Vascular Plug 4 - Instructions for Use.
8. Abbott, AmplatzerTM Vascular Plug - Instructions for use.
9. AVP II is available in 8 unconstrained lengths ranging from 6 -18 mm.
10. Abbott AmplatzerTM Vascular Plug II - Instructions for Use.
MAT-2117128 V1.0
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MAT-2105201 v1.0