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About the AMPLATZ® Canine PDA Device
The Amplatz Canine Duct Occluder is a self-expanding device made from a nitinol wire mesh and is used to close patent ductus arteriosus (PDA) in dogs. A distal flat disk on the pulmonary artery side of the ductal ostium provides secure positioning in the pulmonary artery. As the device is implanted, the proximal cupped disk expands to conform to the shape of the ductal ampulla. The waist of the device spans the pulmonic ostium of the ductus and the dense nitinol mesh occludes the communication.
The Amplatz Canine Duct Occluder is available in several waist diameters as listed in Table 1. The device should be sized relative to the true diameter of the pulmonic ostium of the ductus as measured by arteriography in a ratio between 1.5 and 2. Appropriate sizing is crucial to the success of the procedure and can be accomplished only by arteriography.
Figure 1. Schematic of device indicating measurement of the waist diameter (A). Waist diameter determines the device size.
Sizes
Device Size*
Minimal Required Inner Diameter (ID) of Delivery System
Recommended SHEATH**
Recommended GUIDING CATHETER**
3 mm
.056"
5 F
5 F
4 mm
.060"
5 F
6 F
5 mm
.060"
5 F
6 F
6 mm
.060"
5 F
6 F
7 mm
.073"
5 F
7 F
8 mm
.073"
5 F
7 F
9 mm
.086"
6 F
8 F
10 mm
.099"
7 F
9 F
12 mm
.099"
7 F
9 F
14 mm
.099"
7 F
9 F
* Device size refers to the waist of device as illustrated in Figure 1.
** Please note that a guiding catheter is sized by the Outer diameter (OD) whereas a sheath is sized by the inner diameter (ID). This terminology accounts for the apparent difference in sizes between the guiding catheter and sheath required for a given size device.
Accessories
Safe and accurate delivery of the Amplatz Canine Duct Occluder requires other devices. If you are unsure what you may need to place this device, please contact Infiniti Medical and a representative will assist you in selecting the appropriate accessories.
Delivery system
This is a spiral reinforced braided catheter with hydrophilic coating and inner dilator. The tip of the catheter is specially shaped to allow easy passage through the PDA. Please refer to the reference chart to select the proper size.
Device Size*
Minimal Required Inner Diameter (ID) of Delivery System
Recommended SHEATH**
Recommended GUIDING CATHETER**
3 mm
.056"
5 F
5 F
4 mm
.060"
5 F
6 F
5 mm
.060"
5 F
6 F
6 mm
.060"
5 F
6 F
7 mm
.073"
5 F
7 F
8 mm
.073"
5 F
7 F
9 mm
.086"
6 F
8 F
10 mm
.099"
7 F
9 F
12 mm
.099"
7 F
9 F
14 mm
.099"
7 F
9 F
* Device size refers to the waist of device as illustrated in Figure 1.
** Please note that a guiding catheter is sized by the Outer diameter (OD) whereas a sheath is sized by the inner diameter (ID). This terminology accounts for the apparent difference in sizes between the guiding catheter and sheath required for a given size device.
Vascular Sheath This is a short sheath that is placed in the femoral artery to allow atraumatic and easy passage of catheters and other devices.
Marker Catheter This 5 Fr catheter has a non selective pigtail type distal configuration with metallic markers spaced 1 cm apart. This is used to perform the aortogram for sizing of the ductus to allow for device selection and helps to overcome errors due to magnification.
Guide Wires Infiniti Medical has configured a guide wire that is ideally suited to the unique requirements of this procedure. The wire has moderate stiffness and a short atraumatic tip.
Sterile Procedure Pack This pack contains all the equipment needed for an endovascular procedure including patient drapes, sterile gowns, syringes, and many other helpful accessories. Need picture of sterile pack.
Dilators Constructed of polyurethane and tapered to Infiniti’s guide wires, these are used to serially dilate the femoral artery in cases where the placement of large sheaths is required.