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Table 1. Product Material Composition by Weight (Continued)
Material Description
CAUTION: One or more components of this device contains the following substance defined as CMR 1B in a
concentration above 0.1% weight by weight: Cobalt; Chemical Abstracts Services (CAS) No. 7440-48-4;
EC No. 231-158-0.
Current scientific evidence supports that medical devices manufactured from cobalt alloys and stainless steel
alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.
Directions for Use
Materials for Use with this Device
• 0.035-inch Amplatzer™ Guidewire (9-GW-002)
• Amplatzer™ Talisman™ Delivery Sheath
For more information about the delivery sheath, see the Amplatzer™ Talisman™ Delivery Sheath instructions for use. See
Table 1 in Appendix A: Supplemental Information for information about device sizes and compatible delivery sheaths; see
Table 2 below for sizing guidelines.
The following materials are pre-packaged with the Amplatzer™ Talisman™ PFO Occluder:
• Amplatzer™ Trevisio™ delivery cable attached to occluder
• Loader
• Hemostasis valve with extension tube and three-way stopcock
• Plastic vise
Table 2. Device Sizing Guidelines
PFO Morphology
Simple PFO or
PFO with a non-prominent ASA
PFO where a secure device position and
effective PFO closure can be achieved when
using the 25 mm device size
Complex PFO
PFO with one or more anatomical characteristic
that may complicate the ability to achieve a
secure device position and effective PFO
closure when using the 25 mm device size
PFO with small anatomy
Anatomy not suitable for 25 mm device size
secondary to interference with adjacent cardiac
structures
NOTE: Evaluate the position of the device after deployment, but before detachment. Use echocardiography to ensure that the device does not impinge
on the free atrial wall or aortic root. If the device interferes with an adjacent cardiac structure (such as free atrial wall or aortic root), recapture the device
and redeploy. If device position remains unsatisfactory, recapture the device and either replace with a smaller device (18 mm or 25 mm) or consider
alternative treatments. Use of the 35 mm device should only be considered in cases where a secure device position cannot be achieved with the 30 mm
device.The presence of an ASA alone does not necessarily prevent successful PFO closure with a 25 mm device size. In the RESPECT trial, 180
patients (36%) in the device closure group had an ASA. The 25 mm device size was used in the majority of patients with an ASA (77%) to close the PFO,
and at six months post-implant, effective closure was achieved in 95% of these patients. There were no cases of device embolization in any patient in the
study.
Pre-Procedure Care
• Aspirin (325 mg/day) (or alternative antiplatelet/anticoagulant, if patient has aspirin intolerance) is recommended to be
started at least 24 hours prior to the procedure.
• Antibiotics can be administered periprocedurally at operator's discretion.
• Patients should be fully heparinized throughout the procedure using adequate dosing so as to keep the activated clotting
time (ACT) greater than 200 seconds.
Substances in Material
Example Anatomical Characteristics
1. Absence of ASA, long tunnel, and
thickened septum secundum
2. Non-prominent ASA (<20 mm total
excursion) without a long tunnel (≥10 mm
length) and without a thickened septum
secundum (≥10 mm thickness)
1. ASA (≥10 mm excursion) with long tunnel
(≥10 mm length)
2. ASA (≥10 mm excursion) with thickened
septum secundum (≥10 mm thickness)
3. Prominent ASA with excessive mobility
(≥20 mm total excursion)
4. Lipomatous hypertrophy of septum
secundum (≥15 mm thickness)
1. Septal primum length <20 mm
5
Percent Concentration (% w/w)
Suggested
Amplatzer™ Talisman™
PFO Occluder Size (mm)
25
30 or 35
18
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