Device Description; Z-Trak ® Plus Introduction System; Thoracic Z-Trak ® Plus Introduction Systems - COOK Medical Zenith TX2 Instrucciones De Uso

ZENITH TX2
®
PRO-FORM AND THE Z-TRAk
®
• These recommendations are designed to serve only as a general guideline. They are not intended
to supersede institutional protocols or professional clinical judgement concerning patient care.
• CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
1 DEVICE DESCRIPTION
1.1 Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction
System
Fig. 1
Zenith TX2 Dissection Endovascular Graft with Pro-Form and the Z-Trak Plus Introduction
System
Straight Component
When treating dissections of the descending
thoracic aorta, the Zenith TX2 Dissection Endo-
vascular Graft with Pro-Form and the Z-Trak Plus
Introduction System is typically used in conjunc-
tion with the Zenith® Dissection Endovascular
Stent with the H&L-B One-Shot Introduction Sys-
tem, with Pro-Form. The Zenith TX2 Dissection
Endovascular Graft with Pro-Form and the Z-Trak
Plus Introduction System is for sealing of entry
tear(s). The Zenith Dissecton Endovascular Stent
with the H&L-B One-Shot Introduction System
provides support to delaminated segments of
the aorta. For information regarding the use and
deployment of the Zenith Dissection Stents with
the H&L-B One-Shot Introduction System, please
refer to the Instruction for Use.
The Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduction
System shortest Straight Components can be
used to provide additional lenght to the endo-
vascular graft , both proximal and distal. Ensure
there is a minimum overlap of 2 stents. The
stent graft is constructed of full-thickness woven
Fig. 2
Plus Introduction System. It has a sequential
deployment method with built-in features to
pro vide continuous control of the endovascular
graft throughout the deployment procedure. The
Z-Trak Plus Introduction System enables precise
positioning before deployment of the Straight
Component or Tapered Component. The straight
and tapered graft components are deployed from
a 20 Fr or 22 Fr Z-Trak Plus Intro duc tion System.
These systems use a single trigger-wire release
mechanism to secure the endovascular graft onto
the delivery system until released by the physi-
cian (Figure 2). All delivery systems are compat-
ible with a .035 inch wire guide. For added he-
mostasis, the Captor™ Hemostatic Valve can be
loosened or tightened for the introduction and/
or removal of ancillary devices into and out of
the sheath. All delivery systems feature Flexor
introducer sheaths, which resist kinking and are
hydrophilically coated. Both features are intend-
ed to enhance trackability in the iliac arteries and
thoracic aorta.
To facilitate sheath withdrawal, each graft
component is kept in a longitudinally stretched
condition on the delivery system by locking
4 ENGLISH
DISSECTION ENDOVASCULAR GRAFT WITH
®
Thoracic Z-Trak Plus Introduction System
PLUS INTRODUCTION SYSTEM
®
Radiopaque
Markers
Tapered Component
polyester fabric sewn to self-expanding stainless
steel Cook-Z stents with braided polyester and
monofilament polypropylene suture (Figure 1).
The Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduction
System is fully stented to provide stability and
the expansile force necessary to open the lumen
of the graft during deployment. Additionally, the
Cook-Z stents provide the necessary attachment
and seal of the graft to the vessel wall.
To facilitate fluoroscopic visualization of the stent
graft, four radiopaque markers are positioned
on each end of the Straight Component or Ta-
pered Component. These markers are placed in
a circumferential orientation within 1 mm of the
most proximal aspect of the graft material and
within 1 mm of the most distal aspect of the graft
material.
1.2 Thoracic Z-Trak Plus Introduction System
The Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduction
System is shipped preloaded onto the Z-Trak
Fig. 3
Pre-Tensioned Zenith TX2
Dissection Endovascular Graft
with Pro-Form and the Z-Trak
Plus Introduction System
®
trigger-wires (Fig. 3). These trigger-wires work in
tandem to deliver sequential controlled release
of the Zenith TX2 Dissection Endovascular Graft
with Pro-Form and the Z-Trak Plus Introduction
System during deployment (Fig. 3).
I-ZDEG-EU-1105-394-02