L 035 DCB Catheter Procedure utonix ®

Lutonix® 035 DCB Catheter Procedure
Lutonix® 035 use is comparable to standard PTA.
Note: This procedure overview is not intended as a replacement for the full instructions for use.
Please see the IFU for complete preparation and deployment instructions, as well as additional
contraindications, warnings and precautions.
Step 1: Vessel Preparation
After a guidewire is placed in the vessel, standard balloon
angioplasty for pre-dilatation should be performed to ensure
a clear pathway for delivery of the Lutonix® 035 DCB Catheter.
Adequately pre-dilate to at least 1 mm of the reference vessel
diameter.
Step 2: DCB Transit
Advance to the
target site as
fast as possible.
The Lutonix® 035 DCB Catheter can be introduced through the
recommended sheath or guide catheter. Lutonix® 035 should
be advanced to the target site in the shortest possible time. If
the deployment of Lutonix® 035 exceeds 3 min., the catheter
requires replacement with a new unit. Always advance the
catheter under negative pressure. Do not immerse the balloon in
a saline bath.
Step 3: DCB Placement
The Lutonix® 035 DCB Catheter is positioned across the entire
length of the treatment area and should extend 5 mm proximally
and distally beyond the pre-dilatation to ensure adequate drug
coverage. To ensure optimal therapeutic drug delivery, never
inflate the Lutonix® 035 DCB Catheter prior to reaching the target
lesion.
Bard and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. Copyright 2014 C. R. Bard, Inc. All rights reserved.
Advancing Lives and the Delivery of Health Care™
Lutonix® 035 DCB Catheter Procedure
Step 4: Balloon Inflation
Inflate the Lutonix® 035 DCB Catheter for a minimum of 30
seconds. Do not exceed the recommended Rated Burst
Pressure (RBP) during inflation. The balloon transfers the
therapeutic drug dose during this initial inflation. Inflation times
are not restricted and longer inflation times may be utilized.
However, inflation times beyond 30 seconds will not increase the
therapeutic drug dose.
Step 5: Balloon Removal
Deflate and Retract
The Lutonix® 035 DCB Catheter is deflated and retracted
through the sheath or guide catheter. The balloon may be used
again during the same procedure as a standard PTA balloon, if
needed.
Step 6: Drug Effect
Paclitaxel diffuses into the arterial wall from the endoluminal
surface after drug delivery and is designed to decrease the
incidence of restenosis and improve patency.
Absorbtion
Bard and Lutonix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate. Copyright 2014 C. R. Bard, Inc. All rights reserved.
Advancing Lives and the Delivery of Health Care™