Table des Matières
Publicité
Les langues disponibles
Les langues disponibles
2.3 Product Matrix and Paclitaxel Content
Table 2-2. ELUVIA Drug-Eluting Vascular Stent System Product Matrix and
Paclitaxel Content
Stent
Nominal
Diameter
(mm)
H74939295600470
6
H74939295600670
6
H74939295600870
6
H74939295601070
6
H74939295601270
6
H74939295601570
6
H74939295600410
6
H74939295600610
6
H74939295600810
6
H74939295601010
6
H74939295601210
6
H74939295601510
6
H74939295700470
7
H74939295700670
7
H74939295700870
7
H74939295701070
7
H74939295701270
7
H74939295701570
7
H74939295700410
7
H74939295700610
7
H74939295700810
7
H74939295701010
7
H74939295701210
7
H74939295701510
7
Non-Pyrogenic
ELUVIA Drug-Eluting Vascular Stent System meets pyrogen limit specifications.
User Information
Only physicians, technicians, and nurses experienced in preparing for and performing
peripheral vascular procedures should use this device.
3. INTENDED USE/INDICATIONS FOR USE
The ELUVIA Drug-Eluting Vascular Stent System is intended to improve luminal
diameter in the treatment of symptomatic de-novo or restenotic lesions in the native
superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel
diameters (RVD) ranging from 4.0 mm - 6.0 mm.
39
MB Drawing 50573139
Unconstrained
Working
Reference
Length
Length
Vessel
(mm)
(cm)
Diameter
(mm)
40
75
60
75
80
75
100
75
120
75
150
75
4.0 - 5.0
40
130
60
130
80
130
100
130
120
130
150
130
40
75
60
75
80
75
100
75
120
75
150
75
5.0 - 6.0
40
130
60
130
80
130
100
130
120
130
150
130
Clinical Benefit Statement
The ELUVIA Drug-Eluting Vascular Stent System is designed to improve luminal
diameter in the treatment of symptomatic de-novo or restenotic lesions in the native
superficial femoral artery (SFA) and/or proximal popliteal artery (PPA). Clinical Benefit
Nominal
can be measured by overall clinical outcomes as demonstrated by primary patency
Paclitaxel
rates, freedom from amputation, freedom from TLR and overall survival with respect
Content
to other existing therapies.
(µg)
Summary of Safety and Clinical Performance
135
For customers in the European Union, use the device name found in the labeling
207
to search for the device's Summary of Safety and Clinical Performance, which is
272
available on the European database on medical devices (EUDAMED) website:
(https://ec.europa.eu/tools/eudamed).
344
4. CONTRAINDICATIONS
409
The ELUVIA Drug-Eluting Vascular Stent System is contraindicated for use in any
517
situation in which percutaneous transluminal angioplasty (PTA) is contraindicated.
135
5. WARNINGS
207
5.1 General
272
• Do not use a kinked delivery system.
344
• Only advance the stent delivery system over a recommended guidewire. Use of
409
other guidewires may lead to deployment difficulties resulting in adverse event or
517
need for urgent intervention/surgery.
135
• When catheters are in the body, they should be manipulated only under
fluoroscopy. Radiographic equipment that provides high quality images is needed.
207
• In the event of a bail out procedure (dissection or other complications requiring
272
additional stent placement), stents used should be of similar composition.
344
• Should more than one stent be required, allow for at least 5 mm of stent overlap.
409
• Prior to completion of the procedure, utilize fluoroscopy to ensure proper
positioning of the stent. If the lesion is not fully covered, use additional stents as
517
necessary to adequately treat the lesion.
135
• The minimally acceptable introducer or guide sheath size is printed on the package
207
label. Do not attempt to pass the stent delivery system through a smaller size
introducer or guide sheath than indicated on the label.
272
• In the event of thrombosis of the expanded stent, thrombolysis and/or PTA should
344
be considered.
409
• In the event of complications such as infection or vessel trauma, surgical removal of
517
the stent may be required.
• Recrossing a partially or fully expanded deployed stent with adjunct devices must
be performed with extreme caution to ensure that the adjunct device does not get
caught within previously placed stent struts.
• Do not remove the thumbwheel lock prior to deployment. Premature removal of
the thumbwheel lock may result in an unintended deployment of the stent.
• In the event of stent deployment difficulties (e.g. partial deployment),
manipulation of the device, removal/replacement of the delivery system, or urgent
medical or surgical intervention may be required.
• This product should not be used in patients with uncorrected bleeding disorders or
patients who cannot receive anticoagulation or antiplatelet aggregation therapy.
5
Black (K) ∆E ≤5.0
Publicité
Table des Matières
