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MICROVASCULAR ANASTOMOTIC COUPLER

Shown to be a fast method for Microvascular Anastomosis

The Microvascular Anastomotic COUPLER System has been specifically designed for use in the anastomosis of veins and arteries normally encountered in microsurgical procedures. The COUPLER is intended for use with veins and arteries having an outside diameter no smaller than 0.8mm and no larger than 4.3mm and a wall thickness of 0.5mm or less.1

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Rx Only. For safe and proper use of this device, refer to the Instructions for Use.

Please contact Customer Service for Instructions for Use (IFU). Call 800.510.3318 or email
    • Anastomosis—Intima-to-intima contact without any intraluminal foreign (suture) material which may decrease the rate of thrombosis1
    • Versatility— Manages vessel size mismatches. Simplicity and dependability in both end-to-end and end-to-side anastomotic configurations1

INDICATIONS FOR USE:
The Microvascular Anastomotic COUPLER Device is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The Microvascular Anastomotic COUPLER Device is intended for use with veins and arteries having an outside diameter no smaller than 0.8 mm and no larger than 4.3 mm and a wall thickness of 0.5 mm or less. The degree of vessel spasm and the elasticity of the vessel should be considered when choosing the COUPLER Device size to be used. Use a Vessel Measuring Gauge to approximate the OUTER diameter of the vessel for selection of an appropriate COUPLER Device size.

CONTRAINDICATIONS:

The COUPLER Device is not indicated for use in patients presenting conditions that would normally preclude microvascular repair with suture technique. Examples of such conditions include, but are not limited to:

    • Pre-existing or suspected peripheral vascular disease
    • Ongoing irradiation of the area of reconstruction
    • Clinical infection of the area of reconstruction
    • Anticipated infection due to significant contamination of the
      area of reconstruction
    • Friability of the vascular tissue due to sclerotic conditions
    • Concurrent diabetes mellitus
    • Concurrent corticosteroid therapy
The MCA COUPLER Device and System
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The VENOUS COUPLER Demonstration Video
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COUPLER SYSTEM
GEM2741CC Complete System includes (2) COUPLER Forceps and the following:
GEM2740 Reusable, Titanium-Tipped Anastomotic Instrument
GEM2745 Anodized Aluminum Sterilization Tray
GEM2749 Non-Glare Stainless Steel Double-Ended Vessel Measuring Gauge
GEM4183C (2) COUPLER Forceps,18cm, for everting the vessel over the pins
GEM2551-CS Single layer tray – Includes: Anastomotic Instrument, (2) COUPLER Forceps, Measuring Gauge & (2) MicroClip appliers 15cm
GEM2551-2-CS Double layer tray – Includes: Anastomotic Instrument, (2) COUPLER Forceps, Measuring Gauge & (2) MicroClip appliers 15cm
GEM2750 1.0 mm COUPLER (gray) 6 per box
GEM2751 1.5 mm COUPLER (blue) 6 per box
GEM2752 2.0 mm COUPLER (green) 6 per box
GEM2753 2.5 mm COUPLER (red) 6 per box
GEM2754 3.0 mm COUPLER (yellow) 6 per box
GEM2755 3.5 mm COUPLER (purple) 6 per box
GEM2756 4.0 mm COUPLER (orange) 6 per box
GEM2750/I 1.0 mm COUPLER (gray) single, 1 each
GEM2751/I 1.5 mm COUPLER (blue) single, 1 each
GEM2752/I 2.0 mm COUPLER (green) single, 1 each
GEM2753/I 2.5 mm COUPLER (red) single, 1 each
GEM2754/I 3.0 mm COUPLER (yellow) single, 1 each
GEM2755/I 3.5 mm COUPLER (purple) single, 1 each
GEM2756/I 4.0 mm COUPLER (orange) single, 1 each


*One box includes 6 individual COUPLER(s)

For more information or to place an order please call Customer Service at 800.510.3318 USA or 205.941.0111 or email

Coupler IFU


Large MAC System IFU


For more information or to place an order please call Customer Service at 800.510.3318 USA or 205.941.0111 or email



Reference:
1. Microvascular Anastomotic COUPLER Device and System IFU. Synovis Micro Companies Alliance, Inc.
©Copyright 2020

USMP/MG219/15-0012(2)

SYNOVIS MICRO COMPANIES ALLIANCE, INC., A SUBSIDIARY OF BAXTER INTERNATIONAL INC. ALL RIGHTS RESERVED