Amplatzer Vascular Plug II (AVP II) | Abbott
CARDIOVASCULAR
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The Amplatzer™ Family of Vascular Plugs

AMPLATZER™ VASCULAR PLUG II
(AVP II)

Rapid embolization1 and can adjust to variable landing zones2

  • Multi-layered mesh designed to increase density and flow disturbance3
  • Six planes of cross sectional coverage3 resulting in rapid occlusion1
  • Select a device that is ~30-50% larger in diameter than the target vessel diameter3
amplatzer vascular plug II
amplatzer vascular plug II

Device Description3:

  • 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
  • A plastic vise is also included and may be attached to the delivery wire to facilitate device detachment

Materials3:

  • Plug: Nitinol
  • Delivery wire: Nitinol
  • Marker bands: Platinum
  • Micro screw: Stainless steel
amplatzer vascular plug ii materials

Amplatzer™ Family of Vascular Plugs

  • Amplatzer Vascular Plug (AVP)
    Amplatzer™ Vascular Plug (AVP)
  • Amplatzer Vascular Plug II (AVP II)
    Amplatzer™ Vascular Plug II (AVP II)
  • Amplatzer Vascular Plug 4 (AVP 4)
    Amplatzer™ Vascular Plug 4 (AVP 4)
IMPORTANT SAFETY INFORMATION

References

  1. 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.
  2. AVP II is available in 8 unconstrained lengths ranging from 6 -18 mm.
  3. Amplatzer™ Vascular Plug and Vascular Plug II - Instructions for Use

MAT-2002814 v1.0

IMPORTANT SAFETY INFORMATION

rx-only-logo  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 gnauss/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:
warningWARNING: 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 v2.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.