2
DESyne
®
Novolimus Eluting Coronary Stent System
Instructions For Use
LBL 036-B (2012-07)
Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.
For Export only – not for sale in the USA
This device should only be used by physicians trained in angiography and percutaneous transluminal coronary angioplasty
(PTCA).
1.0
DEVICE DESCRIPTION
The DESyne
®
Novolimus Eluting Coronary Stent System (DESyne NECSS) is comprised of two key components;
the stent coated with Novolimus delivered in a durable polymer and the delivery system.
DESyne NECSS:
The stent is comprised of a pre-mounted balloon expandable cobalt chromium alloy which includes an 8-crown
pattern for the 3.0 and 3.5 mm diameters and a 6-crown pattern for the 2.5 mm diameter. Both stent patterns
maintain a nominal 0.0032 inch (0.081 mm) strut thickness.
The stent is loaded with approximately 5 mcg of Novolimus per mm of stent length delivered via a proprietary
durable methacrylate polymer which allows sustained release of the drug over 12 weeks.
Elixir Medical Delivery System:
The DESyne delivery system incorporates a rapid-exchange delivery system that includes a nylon-blend balloon
and distal shaft and a stainless steel hypotube in the proximal shaft. The total working length of the delivery system
is 139 cm. There are two radiopaque markers located underneath the balloon to aid in visualization and to facilitate
accurate stent placement. Additionally, there are two proximal delivery system shaft markers (90 cm and 100 cm
from the distal tip) that indicate the relative position of the delivery system to the end of a brachial or femoral
guiding catheter tip. The delivery system is compatible with 0.014 inch (0.36 mm) guide wires and 5 French
guiding catheters (minimum inner diameter of 0.058 inches, or 1.5 mm).
The DESyne NECSS label specifications are included in summary format in Table 1.0 below.
Table 1.0
DESyne NECSS Label Specifications
Stent
Diameter
(Nominal)
Stent
Length(s)
(Nominal)
Drug
Dose
(Nominal)
Minimum Guiding
Catheter Compatibility
(ID)
In Vitro Stent
Rated Burst
Pressure (RBP)*
2.5 mm
14 mm
18 mm
23mm
28 mm
65mcg
85mcg
105mcg
125mcg
5F (0.058”)
16 atm
3.0 mm
and
3.5 mm
14 mm
18 mm
23mm
28 mm
65mcg
85mcg
105mcg
125mcg
5F (0.058”)
16 atm
*See package label for product compliance information.
2.0
HOW SUPPLIED
Sterile:
This device is sterilized with ethylene oxide (EtO) gas and is non-pyrogenic
. Do not use the
device if the package is opened or damaged.
Contents:
One Elixir DESyne
®
Novolimus Eluting Coronary Stent System
One flushing needle
Storage:
Store at ≤ 25
o
C.
3.0
INDICATIONS FOR USE
The DESyne NECSS is indicated for improving coronary luminal diameter in patients with symptomatic ischemic
heart disease due to discrete de novo native coronary artery lesions with reference vessel diameters between 2.5 -
3.5 mm and ≤ 24 mm in length. The stent is intended as a permanent implant.
4.0 CONTRAINDICATIONS
The DESyne NECSS is contraindicated for use in:
•
Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
•
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon
5.0
WARNINGS AND PRECAUTIONS
WARNINGS
•
Judicious selection of patients is necessary since the use of this device carries the associated risk of
thrombosis, vascular complications and/or bleeding events.
•
Persons who are unable to tolerate long-term dual antiplatelet therapy (aspirin indefinitely and clopidogrel
for a minimum of 12 months) should not be considered for implantation of the DESyne NECSS.
•
Persons allergic to cobalt chromium alloy (including the major elements cobalt, chromium, tungsten and
nickel) may suffer allergic reaction to this implant.
•
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 stent blockage may require repeat dilatation of the arterial segment containing the stent. The
long term outcome following repeat dilatation of endothelialized stents is not well characterized.
•
To avoid the possibility of dissimilar metal corrosion, do not implant stents of different materials in
tandem where overlap or contact is possible.
•
Consideration should be given to the risks and benefits of use in patients with history of severe reaction to
contrast agents.
•
The safety and effectiveness of using mechanical atherectomy devices (directional atherectomy catheters,
rotational atherectomy catheters) or laser angioplasty catheters in conjunction with DESyne Novolimus
Eluting Stent System implantation have not been established.
PRECAUTIONS
Intended for single use only. Reuse, reprocess or resterilization of the device may result in loss of drug coating
efficacy and/or loss of device integrity and/or contamination which may result in repeat intervention and/or patient
injury, illness or death.
5.1
Stent Handling
•
For single use only.
Do not resterilize or reuse this device. Note product “Use By” date on the label.
•
Do not remove the Stent from the Delivery System
as removal may damage the stent and /or lead to
Stent embolization. The DESyne NECSS is intended to perform as a system. The stent is not designed
to be reloaded onto another delivery device. Attempts to reload the stent may damage the stent and/or
lead to embolization.
• Special care must be taken not to handle or in any way disrupt the stent position on the Delivery System.
This is most important during catheter removal from the packaging, placement over the guide wire and
advancement through the rotating hemostatic valve adapter and guiding catheter hub.
• Do not manipulate (e.g. roll) the stent with your fingers, as this action may loosen the stent from the
delivery system.
• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate
the balloon, as this may cause uneven expansion and difficulty in deployment of the stent.
5.2
Stent Placement
• Predilatation of the lesion is required for safe stent delivery.
•
Do not prepare or pre-inflate the stent delivery system prior to stent deployment
other than as
directed
.
Use balloon purging technique described in Preparation of Delivery System section.
• Implanting a stent may lead to dissection of the vessel proximal or distal to the stented portion and may
cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilatation or
placement of additional stents). If additional stenting is required, stent materials of similar composition
should be used.
• When treating multiple lesions, stent the distal lesion prior to stenting the proximal lesion to reduce the
chance of dislodging the proximal stent.
• Do not expand the stent if it is not properly positioned in the vessel (See Stent/Delivery System Removal
Precautions).
• Stent placement may compromise side branch patency.
•
Do not exceed the Rated Burst Pressure as indicated on the product label
. Balloon pressures should
be monitored during inflation. Use of pressures higher than those specified on the product label may
result in balloon rupture and/or potential vessel damage.
• Should any resistance be felt at any time during either lesion access or removal of the delivery system
pre-stent implantation, the system should be removed as a single unit per the Stent Removal Precautions.
• Stent retrieval methods (use of additional wires, snares and/or forceps) may result in additional trauma
to the coronary vasculature and/or the vascular access site.
• Additional expansion of a deployed stent may cause a flow limiting dissection. This may be treated by
implantation of another stent. When multiple stents are used, the ends should overlap slightly.
• The vascular effect of overlapping stents has not been clinically tested with this device and should be
employed only as medically necessary.
• Ensure the stent is not under dilated. If the deployed stent is not fully apposed to the vessel wall, the
stent may be expanded further with a high pressure non-compliant balloon that is slightly shorter than
the stent. The edges of the balloon should not extend outside of the stented region.
5.3
Stent / Delivery System Removal
Should
any resistance
be felt
at any time
during either lesion access or removal of the Delivery System
before stent implantation, the Delivery System and guiding catheter should be removed as a single unit.
When removing the delivery system as a single unit:
•
Do not retract (withdraw) the Delivery System into the guiding catheter.
•
Position the proximal balloon marker just distal to the tip of the guiding catheter.
•
Advance the guidewire into the coronary anatomy as far distally as safely possible.
•
Tighten the rotating hemostatic valve to secure the delivery system to the guiding catheter;
then remove the guiding catheter and delivery system as a
single unit
.
Failure to follow these steps and/or applying excessive force to the Delivery System can potentially
result in loss or damage to the stent and/or delivery system components.
If it is necessary to retain guide wire position for subsequent artery/lesion access, leave the guide wire in
place and remove all other system components.
5.4
Post-Implant Procedure
When crossing a newly deployed stent with a guide wire, balloon or delivery system, avoid disrupting
the stent geometry.
5.4.1 Magnetic Resonance Imaging (MRI) – Statement
The DESyne
®
Novolimus Eluting Coronary Stent has not been tested for safety in the MRI environment.
Therefore, MRI scans should not be performed on patients post-implantation until the stent has completely
endothelialized to minimize the potential for migration. For a conventional uncoated CoCr cobalt
chromium stent, this period is usually considered to be 8 weeks. This time may be delayed due to the
presence of the drug and polymer coating. This device has not been evaluated for heating in the MRI
environment. The effect of heating in the MRI environment on the drug and polymer coating is not
known. MR image quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the stent.
6.0
DRUG INTERACTION
While no specific clinical data are available, drugs like tacrolimus which act through the same binding protein
(FKBP) may interfere with the efficacy of Novolimus or Rapamycin-type drugs. Drug interaction studies have
English