SIZING BALLOON II – ORDERING INFORMATION
Order No.
9-SB-018
9-SB-024
9-SB-034
Max Defect
Size (mm)
20
27
40
Balloon
Length (cm/mm)
3.5 / 35
4.5 / 45
5.5 / 55
Shaft Size
(Fr)
6.0
7.0
8.0
Usable
Length (cm/mm)
70 / 700
70 / 700
70 / 700
Guidewire
(inch)
0.035
0.035
0.035
Max Balloon
Inflation Volume (cc)
12
25
90
NOTE: Do not insert the balloon catheter through an introducer sheath.
NOTE: Maximum defect size refers to diameter of native defect as measured by echocardiography. Refer to the Instructions for Use for complete listing of Indications and Usage, Contraindications, Warnings and Precautions. Contact AGA Medical Corporation for further information.
AGA Medical Corporation
682 Mendelssohn Avenue
Golden Valley, MN 55427 USA
(888) 546-4407 Toll Free
(763) 513-9227 Phone
(763) 513-9226 Fax www.amplatzer.com
Internet
0473
Only
AMPLATZER® is a registered trademark of AGA MEDICAL CORPORATION.
© AGA MEDICAL CORPORATION, 2006. Not in any way connected with medical gas or equipment sold under the “AGA” brand by AGA AB or its successors. This device may not be available in all markets.
Contact AGA Medical Corporation for availability.
MM00107 (01) Global 4/06
A

Soft distal tip and flexible shaft for improved balloon positioning
Radiopaque marker bands inside the balloon to enhance imaging and defect measurement
The AMPLATZER Sizing Balloon II is indicated for use in sizing cardiovascular defects where an appropriate fit of the occluder is important. Recent publications support the use of balloon sizing of
Atrial Septal Defects as an effective method to properly size the occluder to the defect. Proper sizing may potentially reduce complications from oversized devices.
1
Featuring a new radiopaque marker system for better visualization and positioning, the new Sizing
Balloon II is configured for accurate defect measurement and confident device size selection.
Wider size range of balloons with three balloon sizes
Compliant balloon material for low pressure inflation
1 Amin, Zahid: Hijazi, Ziyad M: et al: Erosion of Amplatzer Septal Occluder Device
After Closure of Secundum Atrial Septal Defects: Review of Registry of
Complications and Recommendations to Minimize Future Risk, Catheterization and Cardiovascular Interventions 63: 496-502 (2004)
A Soft Distal Tip
B Flexible Straight Shaft Compatible with 0.035"
Guidewire
C Triple Lumen Fill Design
D Compliant Soft Balloon
E Central Markers for Accurate Alignment and
Defect Measure
F Proximal Marker 15mm from Central Marker
Provides Scale
Two central radiopaque marker bands provide visual alignment and catheter placement. A more dilute contrast medium may be used to better see the marker bands within the balloon.
Gradually inflate the balloon using color flow echocardiography until there is a cessation of shunt. This indicates a "stop-flow" diameter for the ASD Occluder.
Measure the distance across the balloon at the septal wall contact points to determine appropriate occluder size. A minimal waist in the balloon may be observed, but is not required. Echocardiography sizing is mandatory. Do not inflate the balloon beyond the "stop-flow" point or beyond the balloon's maximum inflation volume.*
*Refer to IFU.
Radiological confirmation of appropriate occluder size can be achieved by gradually moving the image source from a shallow LAO position to visualize the 0.4 mm space between the central markers. Determine the septal wall contact points, and measure the distance across the balloon to those points.
The septal wall may be observed in the narrowest part of the balloon if a minimal waist is visible.