CARDIOVASCULAR
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ADVANCING THE STANDARD OF CARE IN PERIPHERAL EMBOLIZATION

ADVANCING THE STANDARD OF CARE IN PERIPHERAL EMBOLIZATION

Vascular plugs are a more advanced alternative for peripheral embolization. A single device from the AMPLATZERTM Family of Vascular Plugs embolizes a vessel that would often require many coils, which makes it an efficient and cost-effective1 alternative. A vascular plug can also be easily repositioned and redeployed during a procedure for greater precision.

ADVANTAGES OF SINGLE DEVICE OCCLUSION

We have designed our AMPLATZER Family of Vascular Plugs to provide optimal embolization through single device occlusion, with full cross-sectional vessel coverage and precise, controlled deployment.

AMPLATZERTM vascular plugs provide these advantages over coils:

  • Speed: Reduction in procedure times1
  • Efficiency: Reduction in materials used1
  • Precision: Recapturable and redeployable for precise placement
  • Radiation exposure: Reduction in radiation times1
  • Cost-effectiveness: Reduction in procedural costs1

EACH DEVICE IS SPECIALLY DESIGNED

The AMPLATZER Family of Vascular Plugs is a growing family of minimally invasive, implantable devices uniquely designed for various embolization situations.


References

1. Ha, C., & Calcagno, D. (2005). Amplatzer Vascular Plug to occlude the internal iliac arteries in patients undergoing aortoiliac aneurysm repair. Journal of Vascular Surgery, 42(6), 1058-1062. http://www.ncbi.nlm.nih.gov/pubmed/16376192

THREE UNIQUE AMPLATZERTM VASCULAR PLUG DESIGNS

Learn about each device’s specialized design and use. Watch the product demonstrations below to see how each is prepared, delivered and can be repositioned for precise placement.

SHORT LANDING ZONE EMBOLIZATION: AMPLATZERTM VASCULAR PLUG

Amplatzer Amplatzer

With its single lobe and single-layer mesh, the AMPLATZERTM Vascular Plug (AVP) is designed for precise positioning in short landing zones. Its finely braided Nitinol wire mesh provides a high radial force that secures the AVP within the vessel.


VARIABLE LANDING ZONE EMBOLIZATION: AMPLATZER™ VASCULAR PLUG II

Amplatzer Amplatzer

The multilayered, multisegmented design of the AMPLATZERTM Vascular Plug II (AVP II) significantly reduces the time to occlusion1 for transcatheter embolization procedures, while allowing you to maintain complete control during positioning and delivery. This self-expanding device provides full cross-sectional vessel coverage which minimizes migration and recanalization potential.1

The AVP II features multilayered mesh lobes which create six occlusive planes for rapid vessel occlusion.1 The device is available in an array of sizes (3-22 mm) for a wide range of vessel diameters.

LOW-PROFILE EMBOLIZATION: AMPLATZER™ VASCULAR PLUG 4

Amplatzer Amplatzer

The AMPLATZERTM Vascular Plug 4 (AVP 4) is delivered through a 0.038 inch diagnostic catheter, eliminating the need for catheter exchange. The flexible mesh and floppy distal section of the delivery wire enable the AVP 4 to travel through tortuous anatomy with ease. The device’s low-profile design extends its reach to distal vasculature. Its multilayered, double-lobed design provides rapid2 embolization.

SIZES3 OF VARIOUS VEINS AND ARTERIES

References

1. Hahn RT, Pibarot P, Stewart WJ, et al. Comparison of transcatheter and surgical aortic valve replacement in severe aortic stenosis: a longitudinal study of echocardiography parameters in cohort A of the PARTNER trial (Placement of Aortic Transcatheter Valves. J Am Coll Cardiol. 2013;61(25):2514-2521.
2. Reardon MJ, Adams DH, Kleiman NS, et al. 2-year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol. 2015;66(2):113-121.
3. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort-A analysis. J Am Coll Cardiol. 2014;64(13):1323-1334.
4. Zorn GL III, Little SH, Tadros P, et al. Prosthesis-patient mismatch in high-risk patients with severe aortic stenosis: a randomized trial of a self-expanding prosthesis. J Thorac Cardiovasc Surg. 2016;151(4):1014-1023.e.3.
5. Trifecta valve [package insert]. Chicago, IL: Abbott; table 9.
6. Carpentier-Edwards Perimount Magna Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
7. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
8. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
9. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
10. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.

AMPLATZER VASCULAR PLUG

PRODUCT HIGHLIGHTS

  • Designed to provide optimal embolization through single device occlusion and full cross-sectional vessel coverage
  • Controlled, precise delivery with the ability to recapture and reposition the device as needed
  • Single-lobe, single-layer Nitinol mesh design appropriate for short landing zones
  • Deliverable through a 4-6 F sheath or 5-8 F guide catheter
  • 4-16 mm device sizes to treat a range of vessels
Recommended
Vessel Size
Plug Dimensions Minimum Delivery System
Vessel Diameter RANGE
Based on 30–50% plug diameter oversizing (mm)
Model
Number
Diameter
(mm) [A]
Unconstrained
Length (mm) [B]
Constrained Length Range2
[C]
Based on 30–50% plug
diameter oversizing (mm)
Sheaths and Guide Catheters Sheath OR* Guide Catheter
Min Internal
Diameter
(in/mm)
Max
Length**
(cm)
Min Internal
Diameter
(F)
Min Outer
Diameter (F)
2.5 - 3.0 9-PLUG-004 4 7 13.8 - 14.5 .056/1.42 100 4 5
4.0 - 4.5 9-PLUG-006 6 14.8 - 15.1
5.5 - 6.0 9-PLUG-008 8 16.5 - 17.3
6.5 - 7.5 9-PLUG-010 10 17.9 - 18.9 .067/1.70 5 6
8.0 - 9.0 9-PLUG-012 12 8 19.4 - 20.4
9.5 - 11.0 9-PLUG-014 14 20.9 - 22.7 .088/2.24 6 8
10.5 - 12.5 9-PLUG-016 16 21.8 - 24.5
X
CLOSE
AMPLATZER VASCULAR PLUG

*The AMPLATZER Vascular Plug is delivered utilizing either a sheath or guide catheter meeting the minimum internal diameter requirements.
The delivery catheter length should be no more than 100 cm.
**The AMPLATZER Vascular Plug is packaged with a 135 cm nitinol delivery wire.

Contents: 1 each self-expanding Nitinol mesh occlusion device, loader and 135 cm delivery cable

 

Amplatzer Amplatzer

 

AMPLATZER VASCULAR PLUG II

PRODUCT HIGHLIGHTS

  • Designed to provide optimal embolization through single device occlusion and full cross-sectional vessel coverage
  • Controlled, precise delivery with the ability to recapture and reposition the device as needed
  • Rapid1 vessel occlusion provided by the device’s multiple-lobe, multiple-layer Nitinol mesh design
  • Deliverable through a 4-7 F sheath or a 5-9 F guide catheter
  • 3-22 mm device sizes to treat a wide range of vessels
Recommended
Vessel Size
Plug Dimensions Minimum Delivery System
Vessel Diameter RANGE
Based on 30–50% plug diameter oversizing (mm)
Model
Number
Diameter
(mm) [A]
Unconstrained
Length (mm) [B]
Constrained Length Range2
[C]
Based on 30–50% plug
diameter oversizing (mm)
Sheaths and Guide Catheters Sheath OR* Guide Catheter
Min Internal
Diameter
(in/mm)
Max
Length**
(cm)
Min Internal
Diameter
(F)
Min Outer
Diameter (F)
2.0 - 2.5 9-AVP2-003 3 6 14.0 - 14.3 .056/1.42 100 4 5
2.5 - 3.0 9-AVP2-004 4 16.7 - 18.4
4.0 - 4.5 9-AVP2-006 6 21.8 - 23.4
5.5 - 6.0 9-AVP2-008 8 7 25.5 - 29.3
6.5 - 7.5 9-AVP2-010 10 32.6 - 35.7 .070/1.78 5 6
8.0 - 9.0 9-AVP2-012 12 9 40.3 - 43.5
9.5 - 11.0 9-AVP2-014 14 10 43.9 - 49.9 .086/2.18 6 8
10.5 - 12.5 9-AVP2-016 16 12 49.0 - 56.7
12.0 - 14.0 9-AVP2-018 18 14 58.2 - 66.5 .098/2.49 7 9
13.5 - 15.5 9-AVP2-020 20 16 63.5 - 71.3
14.5 - 17.0 9-AVP2-022 22 18 71.8 - 81.1
X
CLOSE
AMPLATZER VASCULAR PLUG II

*The AMPLATZER Vascular Plug II is delivered utilizing either a sheath or guide catheter meeting the minimum internal diameter requirements.
If the inner diameter of the original access catheter is sufficient for the device size selected, that catheter may be used for delivery. The delivery catheter length should be no more than 100 cm.
**The AMPLATZER Vascular Plug II is packaged with a 135 cm nitinol delivery wire.

Contents: 1 each self-expanding Nitinol mesh occlusion device, loader, 135 cm delivery cable and plastic vise

 

Amplatzer Amplatzer

 

AMPLATZER VASCULAR PLUG 4

PRODUCT HIGHLIGHTS

  • Designed to provide optimal embolization through single device occlusion and full cross-sectional vessel coverage
  • Controlled, precise delivery with the ability to recapture and reposition the device as needed
  • Deliverable through an 0.038 inch diagnostic catheter eliminating the need for catheter exchanges
  • Flexible Nitinol mesh design and floppy distal section of the delivery wire enable the device to travel through tortuous anatomies with ease
  • Rapid1 vessel occlusion provided by the device’s multiple-lobe, multiple-layer Nitinol mesh design
Recommended
Vessel Size
Plug Dimensions Minimum Delivery System
Vessel Diameter RANGE
Based on 30–50% plug diameter oversizing (mm)
Model
Number
Diameter
(mm) [A]
Unconstrained
Length (mm) [B]
Constrained Length Range2
[C]
Based on 30–50% plug
diameter oversizing (mm)
Min Internal
Diameter
(in/mm)
Guide
Catheter Min
(F)*
Max Length**
(cm)
2.5 - 3.0 9-AVP038-004 4 10.0 14.3 - 15.2 .038/0.97 4 or 5 125
3.5 - 4.0 9-AVP038-005 5 10.5 16.0 - 17.7
4.0 - 4.5 9-AVP038-006 6 11.0 18.7 - 19.5
4.5 - 5.5 9-AVP038-007 7 12.5 20.4 - 22.7
5.5 - 6.0 9-AVP038-008 8 13.5 24.4 - 26.0
X
CLOSE
AMPLATZER VASCULAR PLUG 4

*The AMPLATZER Vascular Plug 4 has been tested for compatibility with the following diagnostic catheters and corresponding lengths:
- 5F: Boston Scientific IMAGER II (100 cm or less) and Merit Medical Impress (125 cm or less)
- 4F: Cordis TEMPO or TEMPO AQUA (100 cm or less)
**The AMPLATZER Vascular Plug 4 is packaged with a 155 cm-long PTFE-coated delivery wire.
Note: Physicians should exercise their clinical judgment in selection and use of catheters. Refer to the Instructions for Use for each product listed. Manufacturers may make changes to their catheters without notice which may impact their suitability for use with the AMPLATZER Vascular Plug 4. Abbott provides no warranty for use of third-party catheters with its products. Use of other diagnostic catheters may result in the inability to deliver, deploy, or recapture the device.

Contents: 1 each self-expanding Nitinol mesh occlusion device, loader with hemostasis valve and stopcock, 155 cm delivery cable and plastic vise

 

Amplatzer Amplatzer

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. Tests performed by and data on file at Abbott.

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