Warning; Reuse Warning; Device Description; Contents - Boston Scientific ELUVIA Mode D'emploi

ELUVIA
O V E R - T H E - W I R E
Drug-Eluting Vascular Stent System
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNING

A signal for increased risk of late mortality has been identified following the use
of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal
arterial disease beginning approximately 2-3 years post-treatment compared
with the use of non-drug coated devices. There is uncertainty regarding the
magnitude and mechanism for the risk, including the impact of repeat paclitaxel-
coated device exposure. Physicians should discuss this late mortality signal and
the benefits and risks of available treatment options with their patients.

1. REUSE WARNING

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile
barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead
to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
Carefully read all instructions prior to use. Observe all warnings and precautions noted
throughout these instructions. Failure to do so may result in complications.
STERILE – DO NOT RESTERILIZE – SINGLE USE ONLY

2. DEVICE DESCRIPTION

The ELUVIA Drug-Eluting Vascular Stent System is a device/drug combination product
composed of: a device (stent system) and a drug coating (a formulation of paclitaxel
contained in a polymer matrix). The characteristics of the ELUVIA Stent System are
described in Table 2-1.
39 MB Drawing 50573139
™
Table 2-1. ELUVIA Drug-Eluting Vascular Stent System Product Description
ELUVIA Drug-Eluting Vascular Stent System
Available Stent Lengths (mm)
Available Stent Diameters (mm)
Stent Material
Drug Product
Average Stent Length Change At
Vessel Diameter
Delivery System Effective Length (cm)

Contents

• One (1) ELUVIA Stent with Delivery System

Operating Principle

The ELUVIA Stent System is a device/drug combination product composed of
an implantable endoprosthesis (stent), a dual layer drug coating and the stent
delivery system.
ELUVIA consists of a bare metal stent coated with a dual layer system (a formulation
of paclitaxel contained in a polymer matrix). The primer layer (PBMA) promotes the
adhesion of the active layer to the stent. The active layer consists of the drug paclitaxel
combined with the polymer PVDF-HFP. The drug/polymer combination allows the
paclitaxel drug to be efficiently released over a period of time.
The material comprising the stent is a nickel-titanium (Nitinol) shape memory alloy.
Shape memory alloys exhibit special properties including super elasticity and shape
memory. Nitinol can exist in two phases: a martensite phase and an austenite phase.
Changing from the martensite phase to the austenite phase, or the reverse, is referred
to as a phase transformation. During a phase transformation, the atoms rearrange
to a different structure, allowing the material to exhibit different behavior. Phase
transformations can occur as a result of temperature or stress changes in the material.
The stent delivery system (SDS) is a triaxial design, which means that the design
features an outer stationary sheath that aids in stent and delivery system stability
during deployment. The stent delivery system consists of the inner sheath assembly
comprised of two separate components, the inner liner provides the guide wire lumen
for the delivery system and the proximal inner is the delivery system bumper which is
a rigid surface to push against to keep the stent stationary during stent deployment
as the middle sheath is retracted. The middle sheath protects and constrains the stent
prior to stent deployment. The outer sheath provides system stability during stent
deployment. The stent is deployed by retracting the middle sheath of the delivery
system by pulling back on the pull grip and/or using the thumbwheel.
During manufacturing, the ELUVIA Stent undergoes heat treatments which impart
"memory" in the nitinol, allowing it to expand to a specified diameter when exposed
to certain conditions of stress and/or temperature. Then the stent is loaded into the
delivery system, which transforms the stent into the martensite phase.
3
40, 60, 80, 100, 120, 150
6, 7
Nickel Titanium Alloy (NiTi)
A conformal coating of a polymer carrier
consisting of paclitaxel (10% by weight)
and PVDF (polyvinylidine difluoride 90%
by weight) with a maximum nominal drug
content of 517 ug on the largest stent
(7.00 mm x 150 mm).
The ELUVIA deployed stent length
change from the delivery system is
approximately 2.5% on average or less.
75, 130
Black (K) ∆E ≤5.0