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Zenith® TX2® Dissection Endovascular Graft with Pro-Form® Straight Components


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):

The products on this website are available for sale in the United States. Reference Part Numbers are not the same in all countries/regions. For products available in other countries, please choose one of our other websites from the region selector at the top of the site or contact your local Cook Medical representative.

Specifications

Order Number Reference Part Number Instructions
for Use (IFU)
MR
Status
Component
Type
Aortic
Vessel OD
mm
Diameter
mm
More Info
22 mm Diameter
G47437 ZDEG-P-22-79-PF-US
P 20 22 Expand »
Additional Specs
Description
-
Length mm
79
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47436 ZDEG-P-22-117-PF-US
P 20 22 Expand »
Additional Specs
Description
-
Length mm
117
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
24 mm Diameter
G47439 ZDEG-P-24-79-PF-US
P 21 24 Expand »
Additional Specs
Description
-
Length mm
79
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47438 ZDEG-P-24-117-PF-US
P 21 24 Expand »
Additional Specs
Description
-
Length mm
117
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
26 mm Diameter
G47441 ZDEG-P-26-79-PF-US
P 22-23 26 Expand »
Additional Specs
Description
-
Length mm
79
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47440 ZDEG-P-26-136-PF-US
P 22-23 26 Expand »
Additional Specs
Description
-
Length mm
136
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
28 mm Diameter
G47444 ZDEG-P-28-82-PF-US
P 24 28 Expand »
Additional Specs
Description
-
Length mm
82
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47442 ZDEG-P-28-142-PF-US
P 24 28 Expand »
Additional Specs
Description
-
Length mm
142
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47443 ZDEG-P-28-202-PF-US
P 24 28 Expand »
Additional Specs
Description
-
Length mm
202
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
30 mm Diameter
G47447 ZDEG-P-30-82-PF-US
P 25-27 30 Expand »
Additional Specs
Description
-
Length mm
82
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47445 ZDEG-P-30-142-PF-US
P 25-27 30 Expand »
Additional Specs
Description
-
Length mm
142
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47446 ZDEG-P-30-202-PF-US
P 25-27 30 Expand »
Additional Specs
Description
-
Length mm
202
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
32 mm Diameter
G47450 ZDEG-P-32-82-PF-US
P 28-29 32 Expand »
Additional Specs
Description
-
Length mm
82
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47448 ZDEG-P-32-142-PF-US
P 28-29 32 Expand »
Additional Specs
Description
-
Length mm
142
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47449 ZDEG-P-32-202-PF-US
P 28-29 32 Expand »
Additional Specs
Description
-
Length mm
202
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
34 mm Diameter
G47453 ZDEG-P-34-79-PF-US
P 30 34 Expand »
Additional Specs
Description
-
Length mm
79
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47451 ZDEG-P-34-154-PF-US
P 30 34 Expand »
Additional Specs
Description
-
Length mm
154
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47452 ZDEG-P-34-204-PF-US
P 30 34 Expand »
Additional Specs
Description
-
Length mm
204
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
36 mm Diameter
G47456 ZDEG-P-36-79-PF-US
P 31-32 36 Expand »
Additional Specs
Description
-
Length mm
79
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47454 ZDEG-P-36-154-PF-US
P 31-32 36 Expand »
Additional Specs
Description
-
Length mm
154
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47455 ZDEG-P-36-204-PF-US
P 31-32 36 Expand »
Additional Specs
Description
-
Length mm
204
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
38 mm Diameter
G47459 ZDEG-P-38-79-PF-US
P 33-34 38 Expand »
Additional Specs
Description
-
Length mm
79
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47457 ZDEG-P-38-154-PF-US
P 33-34 38 Expand »
Additional Specs
Description
-
Length mm
154
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47458 ZDEG-P-38-204-PF-US
P 33-34 38 Expand »
Additional Specs
Description
-
Length mm
204
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
40 mm Diameter
G47462 ZDEG-P-40-83-PF-US
P 35-36 40 Expand »
Additional Specs
Description
-
Length mm
83
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47460 ZDEG-P-40-164-PF-US
P 35-36 40 Expand »
Additional Specs
Description
-
Length mm
164
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47461 ZDEG-P-40-218-PF-US
P 35-36 40 Expand »
Additional Specs
Description
-
Length mm
218
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
42 mm Diameter
G47465 ZDEG-P-42-83-PF-US
P 37-38 42 Expand »
Additional Specs
Description
-
Length mm
83
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47463 ZDEG-P-42-164-PF-US
P 37-38 42 Expand »
Additional Specs
Description
-
Length mm
164
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47464 ZDEG-P-42-218-PF-US
P 37-38 42 Expand »
Additional Specs
Description
-
Length mm
218
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5

Videos

Zenith Dissection Animation
6311595472112
Zenith Dissection IFU demo video (audio version)
6285457638001
true
brightcove

Documents

Instructional Resource

Zenith Dissection Graft Specifications and Components

AI-D46657-EN-F_M3_1548273377837.pdf »
English

Notice

Zenith Dissection Endovascular System FDA approval letter

P180001_Dissection-Letter_1548428164124.pdf »
English

Zenith Dissection Endovascular System Summary of Clinical Data

Clinical_Study_Summary_for_IFU_441-01EN_with_5yr_IDE_Results_1617913056724.pdf »
English

Spec Sheet

Zenith Dissection Durability 5-year Data Handout

AI-WF43555-EN-F_M3_1691078220625.pdf »
English

Image Library