Argon Medical Devices Option ELITE Manual Del Usuario

Option™ ELITE Retrievable
Vena Cava Filter
Argon Medical Devices, Inc.
1445 Flat Creek Rd
Athens, TX 75751
Tel: +1 (903) 675-9321
Tel: +1 (800) 927 4669
www.argonmedical.com
Option is a Trademark of Argon Medical Devices, Inc.
Manufactured under one or more of the following U.S.
patent: 7,704,266, 8,100,936, 8,162,972 and 8,715,313
Argon Medical Devices, Inc.
1445 Flat Creek Rd
Athens, TX 75751
Tel: +1 (903) 675-9321
Tel: +1 (800) 927 4669
www.argonmedical.com
Option is a Trademark of Argon Medical Devices, Inc.
Manufactured under one or more of the following U.S.
patent: 7,704,266, 8,100,936, 8,162,972 and 8,715,313
Emergo Europe
Prinsessegracht 20
2797
2514 AP The Hague
The Netherlands
+31 70 345 8570
UK Representative:
Argon Medical Devices UK Ltd.
Tel: 01283 538538
Fax: 01283 538400
Web: https://argonmedical.eu.com/
Emergo Europe
Registered Office: Number 1,
Prinsessegracht 20
2797
Eastgate Business Centre,
2514 AP The Hague
The Netherlands
Eastern Avenue, Burton,
+31 70 345 8570
Staffordshire, DE13 0AT
Registered No. 03543457
VAT No. GB 706 4913 37
P/N: 2017-0184-00 Rev. 0520P
Kit Contents
A. Catheter Sheath Introducer
B. Angiographic Vessel Dilator
C. Pusher with Deployment Marker
D. Option™ ELITE Filter in Cartridge
E. Sheath Cap
Sterile. Sterilized with ethylene oxide gas. Nonpyrogenic. Radiopaque. For single use only. Do not
autoclave.
Caution: Not for Sale in the US.
I. Device Description
The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via
percutaneous delivery in the inferior vena cava (IVC).
The self-centering Option™ ELITE Filter is laser cut from nickel –
titanium alloy (Nitinol) tubing. The Option™ ELITE Filter (Figure 2) con-
sists of shape memory Nitinol struts emanating from a central location
and is designed for optimal clot capture. Retention anchors (retention
hooks) are located at the caudal portion of the filter. These anchors are
intended for filter fixation to the vessel wall. The Option™ ELITE Filter is
intended to be used in caval diameters up to 32 mm.
A retrieval hook is centrally located at the cranial extremity.
The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon
deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the
vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent
pulmonary embolism while maintaining caval patency through central filtration.
The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID),
Angiographic Vessel Dilator with an open end, (Figure 3) and a Pusher with deployment marker (Figure 4).
The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between
the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic
visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter
Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering.
The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire
device to position the Catheter Sheath Introducer in the center of the vena cava.
The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored
arrows printed on it that identify assembly orientation, femoral is printed in green (Figure 5A) and jugular
is printed in blue (Figure 5B). The arrow of the desired access site will point into the Catheter Sheath
Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and
linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast
media to the vena cava.
Figure 3: Angiographic Vessel Dilator Tip
Figure 4: Pusher with Deployment Marker
Figure 5A: Femoral Approach Cartridge Orientation
II. Indications For Use
The Option™ ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percu-
taneous placement in the inferior vena cava (IVC) in the following conditions:
w Pulmonary thromboembolism when anticoagulants are contraindicated
w Failure of anticoagulant therapy in thromboembolic disease
w Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional
therapy are reduced
w Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
Option™ ELITE
Vena Cava Filter
Instructions For Use
Catheter Sheath Introducer
5 Fr. ID (6.5 Fr. OD) / 70cm length
Figure 1: Option™ ELITE Filter System
Figure 2: Option™ ELITE Filter
Cranial
Caudal
Figure 5B: Jugular Approach Cartridge Orientation