Table Des Matières - Boston Scientific SYNERGY Mode D'emploi

tabLe of contents
warnInG ................................................................................................................................................ 3
DevIce DescrIptIon............................................................................................................................ 3
Table 1. SYNERGY™ Stent System Product Description ..................................................... 3
Device Component Description ...................................................................................................... 3
Contents .............................................................................................................................................. 3
Drug Eluting Coating Description ................................................................................................... 3
Everolimus .......................................................................................................................................... 3
Figure 1. The Chemical Structure of Everolimus .................................................................... 3
Polymer Carrier.................................................................................................................................. 4
Figure 2. The Chemical Structure of PLGA .............................................................................. 4
Product Matrix ................................................................................................................................... 4
Table 2. SYNERGY Stent System Product Matrix and Everolimus Content ....................... 4
IntenDeD Use/InDIcatIons for Use ............................................................................................ 4
contraInDIcatIons ........................................................................................................................... 4
warnInGs .............................................................................................................................................. 4
precaUtIons......................................................................................................................................... 5
General Precautions ......................................................................................................................... 5
Stent System Handling (also see, Operational Instructions) ..................................................... 5
Stent Placement ................................................................................................................................ 5
Preparation......................................................................................................................................... 5
Placement........................................................................................................................................... 5
Stent System Removal - Pre-deployment ..................................................................................... 5
Stent System Removal - Post-deployment ................................................................................... 5
Table 3. Representative System Deflation Times (seconds) ................................................ 6
Post-Procedure ................................................................................................................................. 6
Brachytherapy ................................................................................................................................... 6
Magnetic Resonance Imaging (MRI) ............................................................................................. 6
3.0 Tesla Temperature Information ................................................................................................. 6
1.5 Tesla Temperature Information ................................................................................................. 6
Image Artifact Information .............................................................................................................. 6
Pre- and Post-Procedure Antiplatelet Regimen .......................................................................... 6
Drug Interactions .............................................................................................................................. 6
Use in Special Populations: ............................................................................................................. 7
Pregnancy .......................................................................................................................................... 7
Use of Multiple Stents ...................................................................................................................... 7
Drug Information: .............................................................................................................................. 7
Mechanism of Action ....................................................................................................................... 7
Drug Interactions .............................................................................................................................. 7
Carcinogenicity, Genotoxicity, and Reproductive Toxicology ................................................... 7
aDverse events .................................................................................................................................. 7
How sUppLIeD....................................................................................................................................... 8
Handling and Storage ....................................................................................................................... 8
operatIonaL InstrUctIons............................................................................................................ 8
Device Selection ............................................................................................................................... 8
Inspection Prior to Use .................................................................................................................... 8
Material Required (not included in stent system package) ....................................................... 8
Preparation......................................................................................................................................... 8
Package Removal ............................................................................................................................. 8
Black (K) ∆E ≤5.0
Guidewire Lumen Flush .................................................................................................................... 8
Balloon Preparation .......................................................................................................................... 9
Delivery Procedure ........................................................................................................................... 9
Deployment Procedure .................................................................................................................... 9
Removal Procedure and Completion ............................................................................................. 9
In vItro InforMatIon ..................................................................................................................... 10
SYNERGY Stent System Compliance ........................................................................................... 10
Table 4. SYNERGY Compliance Chart ..................................................................................... 10
warranty ........................................................................................................................................... 10
2
S