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Zenith® Dissection Endovascular Stent


The Zenith Dissection Endovascular System (Zenith TX2 Dissection Endovascular Graft with Pro-Form and Zenith Dissection Endovascular Stent) is indicated for the endovascular treatment of patients with Type B aortic dissection. The Zenith TX2 Dissection Endovascular Graft with Pro-Form is intended to seal the entry tear(s) and to exclude aneurysms associated with chronic dissections. The Zenith Dissection Endovascular Stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a Zenith TX2 Dissection Endovascular Graft with Pro-Form. The system is indicated for use in patients having suitable vascular anatomy for endovascular repair, including:
• Adequate iliac/femoral access compatible with the required introduction systems
• For the Zenith TX2 Dissection Endovascular Graft with Pro-Form:
     o Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm,
     o Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm, and
• For the Zenith Dissection Endovascular Stent:
     o Diameter at non-aneurysmal intended implant site for the stent (measured outer-wall to outer-wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).

This product line is serviced by the following clinical division(s):

Specifications

Order Number Reference Part Number Instructions
for Use
MR
Status
Aortic
Vessel OD
mm
Diameter
mm
Length
mm
More Info
36 mm Diameter
G47491 ZDES-36-80-US
20-30 36 80 Expand »
Additional Specs
Description
-
Stents
4
Introducer Sheath ID/OD Fr (mm)/mm
16 (5.3)/6.0
G47492 ZDES- 36-120-US
20-30 36 120 Expand »
Additional Specs
Description
-
Stents
6
Introducer Sheath ID/OD Fr (mm)/mm
16 (5.3)/6.0
G47493 ZDES-36-180-US
20-30 36 180 Expand »
Additional Specs
Description
-
Stents
9
Introducer Sheath ID/OD Fr (mm)/mm
16 (5.3)/6.0
46 mm Diameter
G47494 ZDES-46-80-US
31-38 46 80 Expand »
Additional Specs
Description
-
Stents
4
Introducer Sheath ID/OD Fr (mm)/mm
16 (5.3)/6.0
G47495 ZDES-46-120-US
31-38 46 120 Expand »
Additional Specs
Description
-
Stents
6
Introducer Sheath ID/OD Fr (mm)/mm
16 (5.3)/6.0
G47496 ZDES-46-185-US
31-38 46 185 Expand »
Additional Specs
Description
-
Stents
9
Introducer Sheath ID/OD Fr (mm)/mm
16 (5.3)/6.0

Videos

Zenith Dissection Animation

Documents

Instructional Resource

Zenith Dissection Graft Specifications and Components

AI-D46657-EN-F_M3_1548273377837.pdf »
English

Notice

Zenith Dissection Endovascular System Summary of Clinical Data

Clinical_Study_Summary_for_IFU_441-01EN_1553858095939.pdf »
English

Zenith Dissection Endovascular System FDA approval letter

P180001_Dissection-Letter_1548428164124.pdf »
English

Image Library