Omnilink Elite™ Vascular Balloon-Expandable Stent System | ||||||
---|---|---|---|---|---|---|
Stock Number Catheter Length |
Stent Diameter (mm) | Stent Length (mm) | Sheath Compatibility (F) |
Inflation Pressure (atm) | Max Post-Dilation Diameter* (mm) | |
80 (cm) | 135 (cm) | Nominal/RBP | ||||
1012622-12 | 1012629-12 | 6.0 | 12 | 6 | 11 / 14 | 8 |
1012622-16 | 1012629-16 | 6.0 | 16 | 6 | 11 / 14 | 8 |
1012622-19 | 1012629-19 | 6.0 | 19 | 6 | 11 / 14 | 8 |
1012622-29 | 1012629-29 | 6.0 | 29 | 6 | 11 / 14 | 8 |
1012622-39 | 1012629-39 | 6.0 | 39 | 6 | 11 / 14 | 8 |
1012622-59 | 1012629-59 | 6.0 | 59 | 6 | 11 / 14 | 8 |
1012623-12 | 1012630-12 | 7.0 | 12 | 6 | 11 / 14 | 8 |
1012623-16 | 1012630-16 | 7.0 | 16 | 6 | 11 / 14 | 8 |
1012623-19 | 1012630-19 | 7.0 | 19 | 6 | 11 / 14 | 8 |
1012623-29 |
1012630-29 | 7.0 | 29 | 6 | 11 / 14 | 8 |
1012623-39 | 1012630-39 | 7.0 | 39 | 6 | 11 / 14 | 8 |
1012623-59 | 1012630-59 | 7.0 | 59 | 6 | 11 / 14 | 8 |
1012624-19 | 1012631-19 | 8.0 | 19 | 6 | 11 / 14 | 11 |
1012624-29 | 1012631-29 | 8.0 | 29 | 6 | 11 / 14 | 11 |
1012624-39 | 1012631-39 | 8.0 | 39 | 6 | 11 / 14 | 11 |
1012624-59 | 1012631-59 | 8.0 | 59 | 6 | 11 / 14 | 11 |
1012625-19 | 1012632-19 | 9.0 | 19 | 6 | 11 / 14 | 11 |
1012625-29 | 1012632-29 | 9.0 | 29 | 6 | 11 / 14 | 11 |
1012625-39 | 1012632-39 | 9.0 | 39 | 7 | 11 / 14 | 11 |
1012625-59 | 1012632-59 | 9.0 | 59 | 7 | 11 / 14 | 11 |
1012626-19 | 1012633-19 | 10.0 | 19 | 7 | 11 / 14 | 11 |
1012626-29 | 1012633-29 | 10.0 | 29 | 7 | 11 / 14 | 11 |
1012626-39 | 1012633-39 | 10.0 | 39 | 7 | 11 / 14 | 11 |
Data on file at Abbott.
*Omnilink Elite™ PERIPHERAL Vascular Balloon-Expandable Stent System Instructions For Use (IFU). Refer to IFU for additional information.
MAT-2114534 v1.0
The Omnilink Elite™ Stent System is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5.0 mm and ≤ 11.0 mm, and lesion lengths up to 50 mm.
There are no known contraindications.
The device should be used only by physicians trained in angiography and percutaneous transluminal angioplasty and stent placement.
Should unusual resistance be felt at any time during either lesion access or removal of the delivery system post-stent implantation, the entire system should be removed as a single unit.
When removing the Delivery System as a single unit:
Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.
If it is necessary to retain guide wire position for subsequent vessel access, leave the guide wire in place and remove all other system components.
Exercise great care when crossing a newly deployed stent with a guide wire, balloon or Delivery System to avoid disrupting the stent geometry.
MRI Information: Non-clinical testing has demonstrated that the Omnilink Elite™ stent, in single and in overlapped configurations up to 100 mm in length, is MR Conditional as defined in ASTM F2503. It can be scanned safely under the conditions listed in the Instructions for Use.
Potential complications associated with percutaneous iliac artery treatment, including the use of an iliac stent, may include, but are not limited to, the following:
MAT-2114535 v1.0
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