CARDIOVASCULAR
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Advancing the standard of care in peripheral embolization

  • A single device solution that allows for faster procedure times, less radiation exposure and lower procedural costs1,2
  • Rapid embolization even in high-flow vessels1,3,5
  • Designed for precise placement, controlled delivery and fully recapturable
  • A family of plugs for different vessel conditions
  • Limited imaging artifact4

Amplatzer™ Vascular Plug (AVP)

  • Single lobe, single layer device7
  • Platinum marker bands on both ends7
  • Select a device that is ~30-50% larger in diameter than the target vessel diameter7

Amplatzer™ Vascular Plug II (AVP II)

  • Multi-layered mesh designed to increase density and flow disturbance7
  • Six planes of cross sectional coverage7 resulting in rapid occlusion¹
  • Select a device that is ~30-50% larger in diameter than the target vessel diameter7

Amplatzer™ Vascular Plug 4 (AVP 4)

  • Simple delivery through an 0.038” guide wire compatible diagnostic catheter8
  • Easy tracking through tortuous anatomy6
  • Extended reach to distal vasculature6
  • Select a device that is ~30-50% larger in diameter than the target vessel diameter8

Amplatzer™ Vascular Plugs (AVP) Mechanism of Action

The nitinol mesh of an AVP acts as an embolic agent that promotes rapid 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

Indication/ Intended Use

The Amplatzer™ Family of Vascular Plugs are indicated for arterial and venous embolization in the peripheral vasculature.

References

  1. Pech M, Kraetsch A, Wieners 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. Hart JL, Aldin Z, et al. Embolization of pulmonary arteriovenous malformations using the AMPLATZER vascular plug: successful treatment of 69 consecutive patients. Eur Radiol 2010;20(11)2663-70.
  3. Kucukay F, Özdemir M, Şenol E, Okten S, Ereren M, Karan A. Large pulmonary arteriovenous malformations: long-term results of embolization with AMPLATZER vascular plugs. J Vasc Interv Radiol. 2014 Sep;25(9):1327-32. doi: 10.1016/j.jvir.2014.01.031. Epub 2014 Mar 18.
  4. Vandy F, Criado E, Upchurch GR, et al. Translumihnal Hypogastric Artery Occlusion with an Amplatzer Vascular Plug During Endovascular Aortic Aneurysm Repair. J Vasc Surg. 2008; 48(5)1121-4.
  5. Tests performed by and data on file at Abbott.
  6. 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.
  7. Amplatzer™ Vascular Plug and Vascular Plug II - Instructions for Use
  8. Amplatzer™ Vascular Plug 4 – Instructions for Use
IMPORTANT SAFETY INFORMATION

MAT-2002814 v1.0

IMPORTANT SAFETY INFORMATION

rx-only-logo  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.
  • MR Safe

Through non-clinical testing, the AMPLATZER™ Vascular Plug has been shown to be MR safe at field strengths of 3.0 Tesla or less with a maximum whole body averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 Tesla and 5.57 W/kg at 5.0 Tesla for a 20 minute exposure to a B1 of 118 μT. The AMPLATZER™ Vascular Plug should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 Tesla.

In this testing, the device produced a temperature rise of 1.1°C at 1.5 Tesla and 1.6°C at 5.0 Tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

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 and its packaging have been sterilized with ethylene oxide. The packaging may expose you to ethylene oxide, a chemical known to the State of California to cause cancer or birth defects or other reproductive harm.

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.
  • MR Conditional

Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

  • Static magnetic field of 3 tesla or less
  • Spatial gradient magnetic field of 720 G/cm or less
  • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.

rx-only-logo  AMPLATZER™ Vascular Plug 4

 

Indications And Usage: The AMPLATZER™ Vascular Plug 4 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 (eg, cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closures) and neurologic uses have not been established.
  • Do not use this device if the sterile package is open or damaged.
  • Use on or before the last day of the expiration month that is printed on the product packaging label.
  • The 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.
  • Do not use a power injection syringe to inject contrast solution through this device.
  • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.


Precautions:

  • The AMPLATZER™ Vascular Plug 4 device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
  • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after use of the device.
  •  Store in a dry place.
  • 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.
  • Use in specific populations
    • Pregnancy - care should be taken to minimize the radiation exposure to the
      fetus and the mother.
    • Nursing mothers - there has been no quantitative assessment of the presence
      of leachables in breast milk.
  • MR Conditional


Non-clinical testing has demonstrated that the AMPLATZER™ Vascular Plug 4 device is MR Conditional. It can be scanned safely under the following conditions:

  • Static magnetic fields of 3.0 Tesla or less
  • Spatial gradient field of 720 G/cm
  • The maximum whole-body averaged specific absorption rate (SAR) shall be limited to 2.0 W/kg (normal operating mode only) for 15 minutes of scanning
In non-clinical testing, the AMPLATZER™ Vascular Plug 4 produced a temperature rise of less than or equal to:
  • 1.6 °C at a maximum whole-body averaged specific absorption rate (SAR) of 2.1 W/Kg as assessed by calorimetry for 15 minutes of MR scanning in a
    1.5-Tesla/64MHz (Magnetom™, Siemens Medical Solutions (Malvern, PA) Software Numaris/4, Version Syngo™ MR 2002B DHHS Active-shielded, horizontal field scanner) MR system
  •  1.9 °C at a maximum whole-body averaged specific absorption rate (SAR) of 2.7 W/Kg, as assessed by calorimetry for 15 minutes of MR scanning in a
    3 Tesla/128 MHz, Excite™, HDx, Software 14X.M5, General Electric Healthcare (Milwaukee, WI) MR system


MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.


Potential Adverse Events: Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:

  • Air embolus
  • Allergic reaction/toxic effects
  • Bleeding
  • Death
  • Device migration
  • Fever
  • Foreign material embolic event
  • Hemolysis
  • Infection
  • Occlusion of unintended vessel
  • Peripheral embolism
  • Recanalization
  • Residual flow
  • Stroke/TIA
  • Surgical intervention
  • Vascular access site complication
  • Vessel trauma/perforation

MAT-2103601 v1.0

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

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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