1
Manufacturing Facility:
5050 Nathan Lane North
Plymouth, MN 55442 USA
+1.888.546.4407 Toll Free
+1.763.513.9227 Phone
+1.763.513.9226 Fax
www.amplatzer.com
Device Description
The AMPLATZER TorqVue 45° and 180° Delivery Systems are designed to deliver AMPLATZER devices. The device and
delivery system are shipped separately. The body of the sheath is radiopaque for visibility under fluoroscopy.
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 TorqVue 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.
Warnings
• Use on or before the last day of the expiration month noted on the product packaging.
• The delivery system is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to
resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
Figure 1. AMPLATZER TorqVue Delivery System Components
TorqVue
®
45° and 180° Delivery Systems
Instructions for Use
600266-002
11-2009 US
© 2005, 2007
–
2009 AGA Medical Corporation
AMPLATZER and TorqVue are trademarks of AGA Medical Corporation.
AGA Medical products and technologies for which patents are granted and/or pending in the USA
and/or other countries are listed at www.amplatzer.com/patents
Not in any way connected with medical gas or equipment sold under the “AGA” brand by AGA AB
or its successors.
C
D
E
F
A
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*600266-002*
