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When the stent is exposed to body temperature and the middle sheath is retracted
back to deploy the stent, the stent transforms from the martensite to austenite phase
instantaneously. During the austenite phase, the stent will attempt to return to the
diameter that was imparted on the stent during manufacturing. The vessel restricts
expansion of the stent diameter.
Materials
2.1 Device Component Description
The stent system is comprised of: the implantable endoprosthesis and the stent
delivery system. The stent is a laser cut self-expanding stent composed of a nickel
titanium alloy (nitinol). On both the proximal and distal ends of the stent, radiopaque
markers made of tantalum increase visibility of the stent to aid in placement. The stent
is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system
is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle
shaft to protect and constrain the stent, and an inner shaft to provide a guidewire
lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires.
The ELUVIA Drug-Eluting Stent is available in a variety of diameters and lengths. The
delivery system is also offered in two working lengths (75 cm and 130 cm).
2.2 Drug Component Description
The ELUVIA Drug-Eluting Vascular Stent System is a self-expanding nitinol
(nickel-titanium alloy) stent structure with tantalum radiopaque markers coated
with a poly-butyl-methacrylate (PBMA) primar layer and polyvinylidene difluoride
hexafluoropropylene (PVDF-HFD) with paclitaxel active layer. Below are the materials
used in the ELUVIA Stent by percent weight.
Nitinol 99.999%
Paclitaxel <0.1%
PBMA <0.1%
PVDF-HFP <0.1%
Tantalum <0.1%
2.2.1 Paclitaxel Drug
The active pharmaceutical ingredient in the ELUVIA Drug-Eluting Vascular Stent System
is semi-synthetic paclitaxel. Semi-synthetic Paclitaxel is synthesized from precursor
compounds isolated from a spectrum of Taxus species and hybrids. The Chemical name of
paclitaxel is: Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-, 6,12b-bis(acetyloxy)-
12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b- dodecahydro-4,11-dihydroxy-4a,8,13,13-
tetramethyl-5-oxo- 7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester, [2aR-[2aα
,4β,4aβ,6β,9α(αR*,βS*),11α,12α,12aα,12bα]].
Paclitaxel is a diterpenoid with a characteristic taxane skeleton of 20 carbon atoms, a
molecular weight of 853.91 g/mol and a molecular formula of C47H51NO14. It is highly
lipophilic, insoluble in water, but freely soluble in methanol, ethanol, chloroform, ethyl
acetate and dimethyl sulfoxide.
The chemical structure of Paclitaxel is shown in Figure 1.
Black (K) ∆E ≤5.0
Figure 1. Chemical Structure of Paclitaxel (PTx)
2.2.2 Primer Polymer and Drug Matrix Copolymer Carrier
The stent contains a primer polymer layer PBMA - poly (n-butylmethacrylate) between
the bare metal stent and drug matrix layer. The chemical structure of PBMA is provided
below in Figure 2.
CH
2
Figure 2. PBMA - poly (n-butyl methacrylate)
The drug matrix layer is comprised of a semi-crystalline random copolymer,
PVDF – HFP - poly (vinylidene fluoride-co-hexafluoropropylene), blended with
paclitaxel. The chemical structure of PVDF-HFP is provided below in Figure 3.
CH
CF
2
Figure 3. PVDF - HFP- poly (vinylidene fluoride-co-hexafluoropropylene)
4
CH
3
C
n
C
o
o
(
)
CH
2
3
CH
3
F
CF
C
2
2
n
m
CF
3
MB Drawing 50573139
M
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