Table Des Matières - Boston Scientific ELUVIA Mode D'emploi

TABLE OF CONTENTS
WARNING ........................................................................................................................3
1. REUSE WARNING .........................................................................................................3
2. DEVICE DESCRIPTION ..................................................................................................3
Table 2-1. ELUVIA Drug-Eluting Vascular Stent System Product Description .........3
Contents .....................................................................................................................3
Operating Principle .....................................................................................................3
Materials .....................................................................................................................4
2.1 Device Component Description .............................................................................4
2.2 Drug Component Description ...............................................................................4
2.2.1 Paclitaxel Drug ....................................................................................................4
Figure 1. Chemical Structure of Paclitaxel (PTx) ......................................................4
2.2.2 Primer Polymer and Drug Matrix Copolymer Carrier ..........................................4
Figure 2. PBMA - poly (n-butyl methacrylate)........................................................4
Figure 3. PVDF - HFP- poly (vinylidene fluoride-co-hexafluoropropylene) ...........4
2.3 Product Matrix and Paclitaxel Content ..................................................................5
Table 2-2. ELUVIA Drug-Eluting Vascular Stent System Product Matrix and
Paclitaxel Content ..................................................................................................5
Non-Pyrogenic ............................................................................................................5
User Information.........................................................................................................5
3. INTENDED USE/INDICATIONS FOR USE ......................................................................5
Clinical Benefit Statement ..........................................................................................5
Summary of Safety and Clinical Performance .............................................................5
4. CONTRAINDICATIONS .................................................................................................5
5. WARNINGS ..................................................................................................................5
5.1 General ..................................................................................................................5
5.2 Pre- and Post-Procedure Antiplatelet Therapy .................................................... 6
6. PRECAUTIONS ............................................................................................................ 6
6.1 General Precautions ............................................................................................. 6
6.2 Pregnancy/Lactation............................................................................................ 6
6.3 Drug Information ................................................................................................. 6
6.4 Drug Interaction ................................................................................................... 6
6.5 Magnetic Resonance Imaging (MRI) .................................................................... 6
3.0 Tesla Temperature Information ........................................................................... 6
1.5 Tesla Temperature Information ............................................................................ 6
Image Artifact (Per ASTM F2119) .................................................................................7
Recommendations .....................................................................................................7
Black (K) ∆E ≤5.0
7. ADVERSE EVENTS ........................................................................................................7
8. CLINICAL STUDIES .......................................................................................................7
8.1 Summary of the Meta-Analysis: Late Mortality Signal for
Paclitaxel-Coated Devices ...........................................................................................7
9. HOW SUPPLIED ...........................................................................................................7
Device Details .............................................................................................................7
Handling and Storage ................................................................................................ 8
10. OPERATIONAL INSTRUCTIONS ................................................................................ 8
10.1 Inspection Prior To Use ....................................................................................... 8
Additional Items for Safe Use .................................................................................... 8
10.2 Recommended Materials (not included in stent system package) .................... 8
Preparation ................................................................................................................ 8
10.3 Patient Preparation ............................................................................................ 8
10.4 Inject Contrast Media ......................................................................................... 8
10.5 Evaluate and Mark the Stenosis ......................................................................... 8
10.6 Select Proper Stent System ................................................................................ 8
10.7 Preparation of Stent Delivery System ................................................................. 8
Figure 4. Stent Delivery System ............................................................................ 9
Procedure .................................................................................................................. 9
10.8 Delivery Procedures ........................................................................................... 9
10.9 Stent Deployment Procedure (Reference Figure 5) ............................................ 9
Figure 5. Eliminate slack.......................................................................................10
10.10 Recommended Method of Deployment ..........................................................10
Figure 6. Long stents (150 mm) require the pull grip to be retracted only after
the white activation arrow is visible to complete deployment. ...........................10
Disposal .....................................................................................................................11
10.11 Post-Procedure ..................................................................................................11
Implantable Device Patient Information ....................................................................11
INFORMATION TO BRIEF THE PATIENT ..........................................................................11
Expected Lifetime ......................................................................................................11
REFERENCES ...................................................................................................................11
WARRANTY ....................................................................................................................11
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MB Drawing 50573139 M