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Used with INTEGRATED DUAL-LAYER SYSTEM For Optimal Performance and Ease of Use · Easily Trackable with Partial Retrievability · Excellent Visualization · Optimal Stability and Wall Apposition

INTEGRATED DUAL-LAYER SYSTEM - CULPAN MED Brochure.pdf · FRED™ System: Flow Re-direction Endoluminal Device An Integrated Dual-Layer System for Optimal Performance and Ease of

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INTEGRATED DUAL-LAYER SYSTEMFor Optimal Performance and Ease of Use

· Easily Trackable with Partial Retrievability· Excellent Visualization· Optimal Stability and Wall Apposition

Four (4) atraumatic flared ends provide superb anchoring, vessel apposition and expansive conform-ability, to assist device placement stability and accuracy.

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.

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.

Used with

Introducing the FRED™ System with integrated dual-layer stent 16-wire outer stent / 48-wire inner stent for flow re-direction

Image courtesy of Drs. Civan Islak/Naci Kocer Carrahpaspa Medical University HospitalIstanbul, Turkey

Caution: The FRED™ System is an investigational device limited by U.S. law to investigational use.

FRED™ System: Flow Re-direction Endoluminal DeviceAn Integrated Dual-Layer System for Optimal Performance and Ease of UseThe 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.

• 3.5,4.0,4.5,5.0and5.5mmfullyexpandedstent diameters in various lengths to target 3.0mmto5.5mmparentvessels

• Aneurysmneckcoverageisprovidedby theFREDSystem’sproven48-strandflowdiversion inner stent layer plus the supporting 16-strand outer stent layer

• Simplepush-pulldeploymentmethod enables physicians the ability to better control and adjust the metal surface coverage across the aneurysm neck

• A48-wireinnerstentlayer22%to44%metal surface area plus a 16-wire outer stent layer combine for a significant reductionofbloodflowintotheaneurysmwhile providing a stable scaffold with excellent vessel apposition.

Introducing the FRED™ System with integrated dual-layer stent 16-wire outer stent / 48-wire inner stent for flow re-direction

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.

microvention.com

MicroVention, Inc. Worldwide Headquarters 1311 Valencia Avenue Tustin, CA 92780 USAPH +1.714.247.8000PH 1.800.990.8368

Suite 3, The Barracks Building10 Cliffords Fort, North Shields Tyne and Wear, NE30 1JE UKPH +44 (0) 191 258 6777F +44 (0) 191 258 5999

MicroVention UK Limited 30 bis, rue du Vieil Abreuvoir78100 Saint-Germain-en-LayeFrancePH +33 (1) 39 21 77 46F +33 (1) 39 21 16 01

MicroVention Europe, S.A.R.L. Berliner Allee 61D-40212 DusseldorfGermanyPH +49 211 210 798-0F +49 211 210 798-29

MicroVention Deutschland GmbH

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

FRED™ SystemFlow Re-Direction Endoluminal Device

One unit per box

Product Code

Fully Open Implant

Diameter*(mm)

Total Length / Working Length

Fully Open Total Length /

Working Length(mm) (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 31 / 26 23 / 17

4.0mm OD 4.5mm OD

FRED4515 4.5 26 / 19 20 / 13

FRED4525 4.5 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