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Zenith® TX2® Dissection Endovascular Graft with Pro-Form® 8 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
32/24 mm Diameter
G47468 ZDEG-PT-32-24-158-PF-US
PT 28-29 32/24 Expand »
Additional Specs
Description
-
Length
158
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47469 ZDEG-PT-32-24-196-PF-US
PT 28-29 32/24 Expand »
Additional Specs
Description
-
Length
196
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
34/26 mm Diameter
G47472 ZDEG-PT-34-26-156-PF-US
PT 30 34/26 Expand »
Additional Specs
Description
-
Length
156
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
G47473 ZDEG-PT-34-26-194-PF-US
PT 30 34/26 Expand »
Additional Specs
Description
-
Length
194
Introducer Sheath ID/OD Fr (mm)/mm
20 (6.7)/7.7
36/28 mm Diameter
G47476 ZDEG-PT-36-28-159-PF-US
PT 31-32 36/28 Expand »
Additional Specs
Description
-
Length
159
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47477 ZDEG-PT-36-28-199-PF-US
PT 31-32 36/28 Expand »
Additional Specs
Description
-
Length
199
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
38/30 mm Diameter
G47480 ZDEG-PT-38-30-159-PF-US
PT 33-34 38/30 Expand »
Additional Specs
Description
-
Length
159
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47481 ZDEG-PT-38-30-199-PF-US
PT 33-34 38/30 Expand »
Additional Specs
Description
-
Length
199
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
40/32 mm Diameter
G47485 ZDEG-PT-40-32-165-PF-US
PT 35-36 40/32 Expand »
Additional Specs
Description
-
Length
165
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47484 ZDEG-PT-40-32-205-PF-US
PT 35-36 40/32 Expand »
Additional Specs
Description
-
Length
205
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
42/34 mm Diameter
G47488 ZDEG-PT-42-34-160-PF-US
PT 37-38 42/34 Expand »
Additional Specs
Description
-
Length
160
Introducer Sheath ID/OD Fr (mm)/mm
22 (7.3)/8.5
G47489 ZDEG-PT-42-34-210-PF-US
PT 37-38 42/34 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