Abiomed Impella 2.5, Instructions For Use Manual

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B.1 Impella
®
System for Use During Cardiogenic Shock
APPENDIX B: ABIOMED-APPROVED GUIDEWIRES AND
INTRODUCERS (IMPELLA
®
2.5 AND IMPELLA CP
®
)
ABIOMED-APPROVED GUIDEWIRES
Use only Abiomed-tested and supplied guidewires with the Impella
®
Catheter. Guidewires are
specifically designed with unique characteristics to optimize performance of the Impella
®
System.
Guidewires and catheters should always be used in accordance with Abiomed’s instructions.
Table B.1 lists the alternative guidewires that have been tested and approved for use with the
Impella
®
2.5 System.
Table B.1 Alternative Guidewires for Impella
®
2.5 System
Guidewire Catalog number
Boston Scientific Platinum Plus™ ST 0.018 in 46-605, model ST/0.018/260
Boston Scientific V-18 Control Wire™ ST 0.018 in 46-854, model V18/18/300
ALTERNATIVE QUALIFIED INTRODUCER SHEATHS
Abiomed has developed and qualified introducer kits for use with the Impella
®
2.5 and Impella
CP
®
Catheters. These kits were specifically designed for use with the Impella
®
2.5 and Impella
CP
®
Catheters and take into account several technical parameters, such as:
• Size of the sheath (internal diameter and length)
• Blood leakage through the hemostatic valve
• Force required to pass the device through the hemostatic valve
• The ability to replace the introducer with a longer-term sheath
Testing and qualification, based on the above criteria, has been completed.
Table B.2 describes alternative introducer sheaths that have been tested and approved for use
with the Impella
®
System. Use this information to evaluate the performance of these alternative
introducer sheaths relative to each other and to the Abiomed-provided introducer.
Table B.2 Alternative Introducer Sheaths for Impella
®
2.5 and Impella CP
®
System
Manufacture Model Fr Length Catalog Number
Cook Incorporated Check-Flo ® Introducer
(alternative for
Impella ® 2.5 only)
14 13 cm RCF-14.0-38-J
Cook Incorporated Check-Flo Performer
®
Introducer
(non peel-away)
14 30 cm RCFW-14.0-38-30-J
Note: Use of the Cook introducer may require higher than expected insertion and removal forces.
A
P
P
E
N
D
IX
A
P
P
E
N
D
IX B