Medtronic Endeavor Resolute Produktbeschreibung Seite 6

1.0 DEVICE DESCRIPTION
The Endeavor Resolute Zotarolimus-Eluting Coronary
Stent System (referred to as the Endeavor Resolute
Stent/System) consists of four subsystems:
1) Endeavor Resolute Stent – a pre-mounted cobalt alloy
based stent
2) Delivery system (Rapid Exchange [RX] Coronary
System)
3) Polymer system
4) Zotarolimus – drug
1.1 STENT
The Endeavor Resolute Stent is manufactured from a
cobalt alloy. The stents sizes offered are listed in the
table below.
Table 1: Endeavor Resolute Stent Sizes
Diameter Stent Length (mm)
(mm)
2.25 8 12 14 18
2.5 8 12 14 18
2.75 8 12 14 18
3.0 9 12 15 18
3.5 9 12 15 18
4.0 9 12 15 18
1.2 DELIVERY SYSTEM
The delivery system consists of a balloon-expandable
intracoronary stent premounted on an RX delivery system
with a catheter effective working length of 140 cm. The
delivery system has two radiopaque markers to aid in the
placement of the stent during fluoroscopy. The delivery
system is compatible with 0.36 mm (0.014") maximum
outer diameter guidewires and 1.42 mm (5 Fr / 0.056")
minimum inner diameter guide catheters.
RADIOPAQUE MARKERS
DRAWING FOR REFERENCE ONLY; DRAWING NOT TO SCALE
Table 2: Endeavor Resolute Stent Product Information
Nominal Stent ID* Nominal Stent Length**
2.25 mm 8 mm, 12 mm,
2.5 mm 14 mm, 18 mm,
2.75 mm 24 mm, 30 mm
9 mm, 12 mm,
3.0 mm
15 mm, 18 mm,
3.5 mm
24 mm, 30 mm
9 mm, 12 mm,
4.0 mm 15 mm, 18 mm,
24 mm, 30 mm
* After deployment and recoil.
** The actual nominal stent length for the 8 mm stent is 8.4 mm and the actual nominal stent length for the 14 mm
stent is 14.4 mm.
Minimum guide catheter inner diameter ≥ 1.42 mm (5 Fr / 0.056").
1.3 POLYMER SYSTEM
The Endeavor Resolute Stent is comprised of a bare
metal stent with a primer coat and a coating that consists
of a blend of the drug zotarolimus and the BioLinx
polymer system.
1.4 DRUG – ZOTAROLIMUS
The drug zotarolimus is a proprietary chemical entity
licensed from Abbott Laboratories.
Zotarolimus is a tetrazole-containing
macrocyclic drug. The suggested
mechanism of action of zotarolimus
is to bind to FKBP12, leading to the
formation of a trimeric complex with
the protein kinase mTOR (mammalian
target of rapamycin), inhibiting its
activity. Inhibition of mTOR results in
the inhibition of protein phosphorylation
events associated with translation
of mRNA and cell cycle control. The
drug zotarolimus is intended to reduce
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restenosis as an adjunct to coronary
intervention using the Endeavor Resolute
24 30
Stent. The Endeavor Resolute Stent has
a nominal drug dose of 1.6
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per mm of the stent surface area.
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1.5 PRODUCT INFORMATION
Table 2: Endeavor Resolute Stent Product
24 30
Information
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2.0 HOW SUPPLIED
STERILE. FOR SINGLE USE ONLY. The Endeavor
Resolute Stent is sterilized with ethylene oxide (EtO) and
is non-pyrogenic. DO NOT RESTERILIZE. Do not use if
the package has been opened or damaged.
Contents: Package contains one (1) Endeavor Resolute
Zotarolimus-Eluting stent mounted on a rapid exchange
stent delivery system.
Storage: STORE IN THE ORIGINAL CONTAINER. Store
between 15°C and 30°C. Use by the "Use By" date
noted on the package.
The outer pouch contains 2 small packets (one used to
remove oxygen from the pouch and one used to remove
moisture). Please discard these packets after opening
the pouch. Note that the exterior surface of the inner
pouch is not sterile.
Nominal Stent Rated Burst Pressure
Deployment Pressure (RBP)
912 kPa 1621 kPa
(9 atm) (16 atm)
912 kPa 1621 kPa
(9 atm) (16 atm)
912 kPa 1520 kPa
(9 atm) (15 atm)
3.0 INTENDED USE
The Endeavor Resolute Zotarolimus-Eluting Coronary
Stent System is intended for use in patients eligible for
percutaneous transluminal coronary angioplasty (PTCA)
with a reference vessel diameter of 2.25 mm to 4.0 mm.
The Endeavor Resolute Stent is intended to improve
coronary luminal diameters as an adjunct to coronary
interventions and reduce restenosis. The stents are
intended as permanently implanted devices.
4.0 INDICATIONS FOR USE
The Endeavor Resolute Zotarolimus-Eluting Coronary
Stent System is indicated for improving coronary luminal
diameter and reducing restenosis in patients with
symptomatic ischemic heart disease in de novo coronary
artery lesions in native coronary arteries with a reference
vessel diameter of 2.25 mm to 4.0 mm.
5.0 CONTRAINDICATIONS FOR USE
The Endeavor Resolute Stent is contraindicated for use
in:
• Patients with hypersensitivity or allergies to aspirin,
heparin, clopidogrel, ticlopidine, drugs such as
zotarolimus, tacrolimus, sirolimus or similar drugs or
g zotarolimus any other analogue or derivative, polymers, cobalt,
μ
chromium, nickel, molybdenum, or contrast media.
• Patients in whom antiplatelet and/or anticoagulation
therapy is contraindicated.
• Patients who are judged to have a lesion that
prevents complete inflation of an angioplasty
balloon or proper placement of the stent or stent
delivery system.
6.0 WARNINGS AND PRECAUTIONS
• Long-term effects of zotarolimus are currently
unknown.
• The patient's exposure to the drug and polymer
system is directly related to the number of stents
and stent length implanted.
• Safety and effectiveness for direct stenting has not
been established.
• Safety and effectiveness for stenting of saphenous
vein grafts has not been established.
• Judicious selection of patients is necessary since
the use of this device carries the associated risk of
complications listed in Section 7.0 Potential Adverse
Effects. The long-term effects of drug eluting
stents and the risks associated with these implants
are unknown. The lack of knowledge should be
considered in making a risk/benefit assessment for
the patient prior to implantation.
• Administration of appropriate anticoagulant,
antiplatelet and coronary vasodilator therapy is
critical to successful stent implantation.
Note: In the Medtronic RESOLUTE Clinical
Trial, the protocol specified administration
of clopidogrel or ticlopidine was prior to
the procedure and for a period of at least
6 months post-procedure. Likewise,
aspirin was administered per protocol
concomitantly with clopidogrel or ticlopidine
and then continued indefinitely to reduce
the risk of thrombosis. Based on empirical
data from the Medtronic RESOLUTE
Clinical Trial, approximately 78 and
59 percent of the patients remained on
dual antiplatelet therapy at 6 months and
9 months, respectively. See Section 5.0
CONTRAINDICATIONS FOR USE.
• Only physicians who have received appropriate
training should perform implantation of the stent.
• Stent placement should only be performed at
hospitals where emergency coronary artery bypass
graft surgery can be readily performed.
• Subsequent restenosis may require repeat dilatation
of the arterial segment containing the stent. The
long-term outcome following repeat dilatation of
endothelialized coronary stents is unknown at
present.
• While no specific clinical data are available, drugs,
like tacrolimus, that act through the same binding
protein (FKBP) may interfere with the efficacy
of zotarolimus. Zotarolimus is metabolized by
CYP3A4, a human cytochrome P450 enzyme.
Strong inhibitors of CYP3A4 (e.g. ketoconazole)
might cause increased zotarolimus exposure to
levels associated with systemic effects, especially if
multiple stents are deployed. Systemic exposure of
zotarolimus should also be taken into consideration
if the patient is treated concomitantly with systemic
immunosuppressive therapy.
• There are no adequate or well-controlled studies
in pregnant women, lactating women, or men
intending to father children for this product. Animal
fertility studies demonstrated embryo-toxicity
including embryolethality. It is not recommended
that the Endeavor Resolute Stent be used in
women attempting to conceive, or who are pregnant
or lactating. Studies in male rats resulted in
reversible, dose-related testicular toxicity.
• When multiple stents are required, stent materials
should be of similar composition. Placing multiple
stents of different materials in contact with each
other may increase potential for corrosion. Data
obtained from in vitro corrosion tests using F562
CoCr alloy stent (Medtronic Driver Coronary Stent)
in combination with a 316L stainless steel alloy
stent (Medtronic S7 Coronary Stent) do not suggest
an increased risk of in vivo corrosion.
• Potential interactions of the Endeavor Resolute
Stent with other drug eluting stents have not
been evaluated and should be avoided whenever
possible.
6.1 STENT HANDLING – PRECAUTIONS
• Do not use if package has been opened or
damaged.
• For single use only. Do not re-sterilize or reuse.
Note product "Use By" date.
• Do not remove stent from the stent delivery
system as removal may damage the stent and
polymer system and/or lead to stent embolization.
The Endeavor Resolute Zotarolimus-Eluting
Coronary Stent System is intended to perform as
a system. The stent is not designed to be crimped
onto another delivery device.
• The Endeavor Resolute stent delivery system
should not be used in conjunction with any other
stents or for post-dilatation.
• Stent manipulation (e.g., rolling the mounted stent)
may cause coating damage, contamination, or
dislodgement of the stent from the delivery balloon.
• Special care must be taken not to handle or in
any way disrupt the stent position on the delivery
device. This is most important during catheter
removal from packaging, placement over guidewire,
and advancement through rotating hemostatic valve
adapter and guide catheter hub.
• The Endeavor Resolute Stent must not be
exposed to any direct handling (e.g. rolling
of the stent) or contact with liquids prior to
preparation and delivery as the coating may
be susceptible to damage or premature drug
elution.
• Do not expose or wipe the device with organic
solvents such as alcohol.
• Use only the appropriate balloon inflation media.
Do not use air or any gaseous medium to inflate
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