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TAXUS® Liberté® TAXUS® Liberté® Atom™ TAXUS® Liberté® Long 6 PRECAUTIONS...................................................................................................2 8.4 TAXUS IV ...................................................................................................6 6.1 General Precautions ...............................................................................2 8.5 TAXUS V ....................................................................................................6 2013-05 6.2 Pre-and Post-Procedure Antiplatelet Regimen .................................3 8.6 HORIZONS AMI Clinical Trial ................................................................6 90814812-01 < EN > 6.2.1 Oral Antiplatelet Therapy ............................................................3 9 ADVERSE EVENTS ............................................................................................6 ® ® 6.3 Use of Multiple Stents ............................................................................3 9.1 Observed Adverse Events......................................................................6 TAXUS Liberté 6.4 Brachytherapy .........................................................................................3 9.2 Potential Adverse Events .......................................................................8 6.5 Use in Conjunction with Other Procedures .......................................3 10 CLINICAL STUDIES .........................................................................................8 ® ® ™ 6.6 Use in Special Populations ....................................................................3 10.1 TAXUS ATLAS U.S. Pivotal Clinical Trial ............................................8 TAXUS Liberté Atom 6.6.1 Pregnancy.......................................................................................3 10.2 TAXUS ATLAS Program Small Vessel 2.25 mm Clinical Trial ........11 ® ® 6.6.2 Lactation .........................................................................................3 10.3 TAXUS ATLAS Program Long Lesion 38 mm Clinical Trial ............13 TAXUS Liberté Long 6.6.3 Gender .............................................................................................3 10.4 TAXUS IV Pivotal Clinical Trial ..........................................................15 6.6.4 Ethnicity...........................................................................................3 10.5 TAXUS V de novo Expansion Clinical Trial ......................................16 MONORAIL® 6.6.5 Pediatric Use ..................................................................................3 10.6 HORIZONS AMI Clinical Trial ............................................................17 6.6.6 Geriatric Use ..................................................................................3 10.7 Sex-Specific Information from Pooled Analysis ............................21 6.7 Lesion/Vessel Characteristics .............................................................3 OVER-THE-WIRE 11 INDIVIDUALIZATION OF TREATMENT ......................................................23 6.8 Drug Interaction ......................................................................................4 12 PATIENT COUNSELING INFORMATION ....................................................23 6.9 Magnetic Resonance Imaging (MRI) ...................................................4 Paclitaxel-Eluting Coronary Stent System 13 HOW SUPPLIED.............................................................................................23 6.10 Stent Handling .......................................................................................4 6.11 Stent Placement ....................................................................................4 14 OPERATIONAL INSTRUCTIONS..................................................................23 TABLE OF CONTENTS 6.12 Stent System Removal..........................................................................4 14.1 Inspection Prior to Use.......................................................................23 1 WARNING ..........................................................................................................1 6.13 Post-Procedure .....................................................................................4 14.2 Materials Required (not included in Stent System package) ......23 14.3 Preparation...........................................................................................23 2 DEVICE DESCRIPTION......................................................................................1 7 DRUG INFORMATION .......................................................................................4 14.3.1 Packaging Removal...................................................................23 2.1 Contents ...................................................................................................2 7.1 Mechanism of Action .............................................................................4 14.3.2 Guidewire Lumen Flush ............................................................23 2.2 Device Component Description ............................................................2 7.2 Pharmacokinetics ...................................................................................4 14.3.3 Balloon Preparation ..................................................................23 2.3 Drug Component Description ................................................................2 7.3 Drug Interactions ....................................................................................4 14.3.4 Delivery Procedure ...................................................................23 2.3.1 Paclitaxel ........................................................................................2 7.4 Carcinogenicity, Genotoxicity, and Reproductive Toxicology .........4 14.3.5 Deployment Procedure.............................................................24 2.3.2 Translute™ Polymer Carrier ........................................................2 7.5 Pregnancy ................................................................................................5 14.3.6 Removal Procedure...................................................................24 2.3.3 Product Matrix and Paclitaxel Content .....................................2 7.6 Lactation ...................................................................................................5 14.4 Post-Deployment Dilatation of Stented Segments ........................24 3 INTENDED USE/INDICATIONS FOR USE.......................................................2 8 OVERVIEW OF CLINICAL STUDIES ................................................................5 14.5 In Vitro Information .............................................................................24 4 CONTRAINDICATIONS .....................................................................................2 8.1 TAXUS ATLAS ..........................................................................................5 15 REFERENCES..................................................................................................24 5 WARNINGS ........................................................................................................2 8.2 TAXUS ATLAS Small Vessel ...................................................................5 8.3 TAXUS ATLAS Long Lesion ....................................................................5 16 WARRANTY ...................................................................................................24 ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. Table 2.1 TAXUS Liberté Stent System Product Description TAXUS Liberté TAXUS Liberté This device is supplied in sterile condition. All materials inside Monorail Stent Delivery System Over-the-Wire Stent Delivery System the sterile barrier pouch (the delivery system and stent, as well 1 as the carrier tube and pouch liner) are sterile. The external Available Stent Lengths (mm) 8, 12, 16, 20, 24, 28, 32, 38 surface of the sterile barrier pouch, as well as the product Available Stent Diameters (mm) 2.25, 2.50, 2.75, 3.00, 3.50, 4.00 carton, should not be considered sterile. Stent Material A 316L surgical grade stainless steel VeriFLEX® Stent 1 WARNING A conformal coating of a polymer carrier loaded with 1 µg/mm2 paclitaxel in a slow release (SR)2 Contents supplied STERILE using an ethylene oxide (EO) Drug Product formulation applied to the stent with a maximum nominal drug content of 273 µg on the largest process. Do not use if sterile barrier is damaged. If damage is stent (4.00 x 38 mm). found, call your Boston Scientific representative. Delivery System For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the Effective Length 144 cm 138 cm structural integrity of the device and/or lead to device failure Y-Connector (Side arm for access which, in turn, may result in patient injury, illness or death. Single access port to inflation lumen. Guidewire exit port is to balloon inflation/deflation lumen. Delivery System Y-Adapter Reuse, reprocessing or resterilization may also create a risk of located approximately 25 cm from tip. Designed for Straight arm is continuous with shaft Ports contamination of the device and/or cause patient infection or guidewire ≤ 0.014 in (0.36 mm) inner lumen). Designed for guidewire cross-infection, including, but not limited to, the transmission of ≤ 0.014 in (0.36 mm) infectious disease(s) from one patient
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