integrated dual-layer system

INTEGRATED DUAL-LAYER SYSTEM
For Optimal Performance and Ease of Use
· Easily Trackable with Partial Retrievability
· Excellent Visualization
· Optimal Stability and Wall Apposition
Used with
Used with
Introducing the FRED™ System with inte
16-wire outer stent / 48-wire inner stent
Braided self-expanding nickel
titanium, paired-stent design.
Enables simultaneous, dynamic push/
pull dual-stent deployment with single
operator ease of use. Easy stent opening
and superb vessel apposition, with
partial resheathability.
Four (4) atraumatic flared ends
provide superb anchoring, vessel
apposition and expansive conformability, to assist device placement
stability and accuracy.
Radiopaque distal wire tip, proximal and
distal markers and interweaved working length
helical strands.
Provides full-stent length fluoroscopic
visualization for good stent placement
accuracy.
Image courtesy of Drs.
Civan Islak/Naci Kocer
Carrahpaspa Medical
University Hospital
Istanbul, Turkey
Caution: The FRED™ System is an investigational device limited by U.S. law to investigational use.
egrated dual-layer stent
for flow re-direction
FRED™ System:
Flow Re-direction
Endoluminal Device
An Integrated Dual-Layer
System for Optimal
Performance and Ease of Use
The FRED System is a unique integrated
dual-layer design that can be simultaneously
deployed or partially retrieved by a single
operator. Its self-expanding closed cell design
improves ease of use while radiopaque end
markers and helical strands assist device
placement accuracy.
• 3.5, 4.0, 4.5, 5.0 and 5.5mm fully expanded
stent diameters in various lengths to target
3.0mm to 5.5mm parent vessels
• Aneurysm neck coverage is provided by
the FRED System’s proven 48-strand flow
diversion inner stent layer plus the
supporting 16-strand outer stent layer
• Simple push-pull deployment method
enables physicians the ability to better
control and adjust the metal surface
coverage across the aneurysm neck
Integrated dual-layer coverage. 16-wire outer
stent with 48-wire inner stent for enhanced
radial force.
Inner stent provides high percentage metal
surface area for flow re-direction.
• A 48-wire inner stent layer 22% to 44%
metal surface area plus a 16-wire outer
stent layer combine for a significant
reduction of blood flow into the aneurysm
while providing a stable scaffold with
excellent vessel apposition.
FRED™ System
Flow Re-Direction Endoluminal Device
One unit per box
Product
Code
Fully Open
Implant
Diameter *
(mm)
Total Length /
Working Length
(mm)
Fully Open
Total Length /
Working Length
(mm)
3.0mm OD
3.5mm OD
FRED3505
3.5
16 / 10
13 / 7
FRED3525
3.5
30 / 24
22 / 16
3.5mm OD
4.0mm OD
FRED4015
4.0
24 / 18
18 / 12
FRED4025
4.0
FRED4515
4.5
FRED4525
4.5
31 / 26
23 / 17
4.0mm OD
4.5mm OD
26 / 19
20 / 13
34 / 27
25 / 18
4.5mm OD
5.0mm OD
FRED5015
5.0
26 / 20
21 /14
FRED5025
5.0
35 / 28
26 / 20
5.0mm OD
5.5mm OD
FRED5515
5.5
28 / 22
22 / 15
FRED5535
5.5
46 / 38
32 / 25
Notes:
Compatible Microcatheter All Models: Headway® 27 (inner diameter = 0.027 inch or 0.69mm)
* Fully Expanded (Max) OD with no constraints
MicroVention, Inc.
Worldwide Headquarters
microvention.com
1311 Valencia Avenue
Tustin, CA 92780 USA
PH+1.714.247.8000
PH 1.800.990.8368
MicroVention UK Limited
MicroVention Europe, S.A.R.L.
MicroVention Deutschland GmbH
Suite 3, The Barracks Building
10 Cliffords Fort, North Shields
Tyne and Wear, NE30 1JE UK
PH +44 (0) 191 258 6777
F +44 (0) 191 258 5999
30 bis, rue du Vieil Abreuvoir
78100 Saint-Germain-en-Laye
France
PH +33 (1) 39 21 77 46
F +33 (1) 39 21 16 01
Berliner Allee 61D-40212
Dusseldorf
Germany
PH +49 211 210 798-0
F +49 211 210 798-29
MICROVENTION and Headway are registered trademarks of MicroVention, Inc. FRED is a trademark of MicroVention, Inc. • Scientific
and clinical data related to this document are on file at MicroVention, Inc. Refer to Instructions for Use for additional information.
© 2013 MicroVention, Inc. MM281(I) 1/13