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Figure 4. Stent Delivery System
Procedure
10.8 Delivery Procedures
1. Gain arterial access utilizing a 6F (2.1 mm) or larger sheath with a hemostatic valve.
Precaution: Always use an introducer or guide sheath for the implant procedure, to
protect the access site and prevent system damage.
Precaution: Do not use a kinked delivery system. Kinking of the introducer/guide
sheath at the access site can restrict the movement of the delivery system
during deployment.
2. Pass a 0.035 in (0.89 mm) guidewire of appropriate length (300 cm length
recommended for 130 cm stent delivery system length systems) across the lesion
or obstruction.
Note: A stiff 0.035 in (0.89 mm) guidewire is strongly recommended for
deployment of the stent, especially for tortuous anatomy and contralateral
approaches. Use of undersized guidewires may lead to insufficient support of the
device which can compromise stent delivery.
Note: If using a hydrophilic guidewire, ensure that it is hydrated at all times.
3. Pre-dilate the lesion with a balloon dilatation catheter using conventional technique.
After the lesion has been properly dilated, remove the dilatation catheter, leaving the
guidewire with the tip distal to the lesion for stent system advancement.
39
MB Drawing 50573139
Thumbwheel [4]
Middle Shaft
Radiopaque
Marker Band
Radiopaque Tip
[5]
Approx. 3 mm
(Approx. 18 mm)
[2]
Thumbwheel Lock
Radiopaque Distal
Markers on Stent
[1]
Precaution: Physicians should use judgment based on experience in dilating
arterial lesions and/or obstructions. Never force a balloon catheter to inflate to the
point of risking dissection of the arterial wall.
4. Place the ELUVIA Drug-Eluting Stent Delivery System over the guidewire. Advance
the delivery system as a unit through the hemostatic valve of the introducer or
guide sheath.
Note: Do not tighten toughy-borst such that it restricts the movement of the
delivery system.
Note: Do not remove the thumbwheel lock prior to deployment. Premature removal
of the thumbwheel lock may result in an unintended deployment of the stent.
10.9 Stent Deployment Procedure (Reference Figure 5)
1. Remove slack from the system by advancing the system just beyond the lesion,
then, pulling the system back until stent radiopaque markers [1] are centered over
the target lesion.
Note: Prior to deployment, ensure adequate distance between the proximal end
of the stent and the introducer/guide sheath to prevent deployment within the
introducer/guide sheath.
2. Remove the thumbwheel lock [2] by compressing the tabs and pulling. Confirm
that the radiopaque markers are still properly positioned across the lesion.
9
Pull Grip
[3]
[6]
Flushing Luer
Radiopaque Proximal
Markers on Stent
Black (K) ∆E ≤5.0
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