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Manufacturing facility:
Abbott Medical

5050 Nathan Lane North   
Plymouth, MN 
55442 USA
+1 855 478 5833
+1 651 756 5833

ARTEN600052467 B

2019-02

™ Indicates a trademark of the Abbott group of companies. 
‡ Indicates a third party trademark, which is property of its respective owner.
Pat. http://www.abbott.com/patents
© 2019 Abbott. All Rights Reserved.

Device Description

The Amplatzer™ Trevisio™ Intravascular Delivery System is designed to deliver Amplatzer™ devices. The device and delivery 
system are shipped separately. The body of the sheath is radiopaque for visibility under fluoroscopy. 

 

Figure 1. Amplatzer™ Trevisio™ Intravascular Delivery System Components

A. Loader – Introduces an Amplatzer

 device into the sheath

B. Hemostasis valve with extension tube and stopcock – Allows flushing of the delivery system and controls blood backflow
C. Sheath – Provides a pathway through which an Amplatzer

 device is delivered

D. Dilator – Eases penetration of tissue and minimizes vessel trauma
E. Delivery cable – Attaches to the device to control its movement through the sheath
F. Plastic vise – Attaches to the delivery cable and serves as a handle for disconnecting (unscrewing) the delivery cable from a 

device

Indications and Usage

The Amplatzer™ Trevisio™ Intravascular Delivery System is intended to provide a pathway through which devices are 
introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

Contraindications

None known.

Amplatzer™ Trevisio™ 
Intravascular Delivery System

Instructions for Use

Summary of Contents for Amplatzer Trevisio 9-ATV06F45

Page 1: ...troduces an Amplatzer device into the sheath B Hemostasis valve with extension tube and stopcock Allows flushing of the delivery system and controls blood backflow C Sheath Provides a pathway through which an Amplatzer device is delivered D Dilator Eases penetration of tissue and minimizes vessel trauma E Delivery cable Attaches to the device to control its movement through the sheath F Plastic vi...

Page 2: ... to avoid damaging tissue and vessels or interfering with previously implanted medical devices Use standard transcatheter techniques when using Amplatzer products Potential Adverse Events Potential adverse events that may occur during or after a procedure using this delivery system may include but are not limited to Device Compatibility The Amplatzer devices compatible with the Amplatzer Trevisio ...

Page 3: ...or use 8 Turn the rotating luer on the dilator counterclockwise to unlock the dilator Slowly remove the dilator from the sheath WARNING Remove the dilator slowly to prevent an ingress of air 9 Allow blood backflow to purge any air from the sheath 10 Attach the hemostasis valve to the proximal end of the loader and flush with sterile saline CAUTION Use the hemostasis valve to impede blood backflow ...

Page 4: ...tt Medical and after confirmed to be defective by the manufacturer EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY ABBOTT MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND EXPRESS OR IMPLIED INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE See the Terms and Conditions of Sale for further information State of California USA Only WARNING This product can expo...

Page 5: ...package is damaged Not made with natural rubber latex Inner diameter Outer diameter Length Usable length Recommended delivery sheath catheter dimensions Caution Federal law restricts this device to sale by or on the order of a physician Quantity Date of manufacture Intravascular Delivery System ONLY ...

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