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™