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Zenith® TX2® Dissection Endovascular Graft with Pro-Form® 4 mm Tapered 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):

Specifications

Order Number Reference Part Number Instructions
for Use
MR
Status
Component
Type
Aortic
Vessel OD
mm
Proximal/Distal
Diameter
mm
More Info
32/28 mm Diameter
G47466 ZDEG-PT-32-162-PF-US
PT 28-29 32/28 Expand »
Additional Specs
Description
-
Length
162
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47467 ZDEG-PT-32-202-PF-US
PT 28-29 32/28 Expand »
Additional Specs
Description
-
Length
202
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
34/30 mm Diameter
G47470 ZDEG-PT-34-159-PF-US
PT 30 34/30 Expand »
Additional Specs
Description
-
Length
159
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47471 ZDEG-PT-34-199-PF-US
PT 30 34/30 Expand »
Additional Specs
Description
-
Length
199
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
36/32 mm Diameter
G47474 ZDEG-PT-36-159-PF-US
PT 31-32 36/32 Expand »
Additional Specs
Description
-
Length
159
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47475 ZDEG-PT-36-199-PF-US
PT 31-32 36/32 Expand »
Additional Specs
Description
-
Length
199
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
38/34 mm Diameter
G47478 ZDEG-PT-38-154-PF-US
PT 33-34 38/34 Expand »
Additional Specs
Description
-
Length
154
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47479 ZDEG-PT-38-204-PF-US
PT 33-34 38/34 Expand »
Additional Specs
Description
-
Length
204
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
40/36 mm Diameter
G47482 ZDEG-PT-40-160-PF-US
PT 35-36 40/36 Expand »
Additional Specs
Description
-
Length
160
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47483 ZDEG-PT-40-210-PF-US
PT 35-36 40/36 Expand »
Additional Specs
Description
-
Length
210
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
42/38 mm Diameter
G47486 ZDEG-PT-42-160-PF-US
PT 37-38 42/38 Expand »
Additional Specs
Description
-
Length
160
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47487 ZDEG-PT-42-210-PF-US
PT 37-38 42/38 Expand »
Additional Specs
Description
-
Length
210
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5

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