3
DESyne
®
Novolimus Eluting Coronary Stent System
Instructions For Use
LBL 036-B (2012-07)
not been performed. Rapamycin-type drugs are metabolized by CYP3A4. Strong inhibitors of CYP3A4 (e.g.
ketoconazol) might cause increased Novolimus exposures to levels associated with systemic effects, especially if
multiple stents are deployed. Systemic exposure of Novolimus or Rapamycin-type drugs should also be taken into
consideration if the patient is treated concomitantly with systemic immunosuppressive therapy. Grapefruit may
potentially interfere with the metabolism of Novolimus.
7.0
POTENTIAL ADVERSE EVENTS
Adverse events which may be associated with the implantation of a coronary stent or PTCA procedure include (in
alphabetical order):
• Abrupt Closure
• Allergic reaction (contrast media or cobalt chromium alloy)
• Aneurysm, pseudoaneurysm
• Angina
• Arrhythmias
• Arteriovenous fistula
• Cardiac tamponade
• Damage to the vessel requiring CABG
• Death
• Dissection, perforation or rupture of the coronary artery
• Drug reactions to antiplatelet/anticoagulation agents or contrast media
• Embolism (air, tissue, device or thrombus)
• Failure to deliver the device to the intended site
• Hemorrhage
• Hypotension/hypertension
• Infection and pain at the insertion site
• Myocardial ischemia and/or infarction
• Occlusion of the artery
• Peripheral ischemia
• Restenosis of the stented artery
• Stent migration, embolization or misplacement
• Stroke/transient ischemic attack
• Thrombosis (acute, subacute or late)
• Ventricular fibrillation
• Vessel spasm
The following additional side effects/complications may be associated with, but not limited to the use of Novolimus
or Rapamycin-type drugs:
• Acne
• Diarrhea or constipation
• Headache
• Increased blood pressure
• Increased cholesterol or triglyceride levels
• Insomnia
• Nausea
• Rash
• Sore or weak muscles or joints
• Tremor
• Upper respiratory or urinary tract infections
• Water retention
8.0
PATIENT SELECTION AND TREATMENT
8.1
Individualization of Treatment
The risks and benefits should be carefully considered for each patient before use of the DESyne NECSS.
Patient selection factors to be assessed should include a judgment regarding risk of anticoagulation therapy.
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. Stenting
should be generally avoided in those patients at heightened risk of bleeding (e.g., those patients with
recently active gastritis or peptic ulcer disease) in which anticoagulation therapy would be contraindicated.
Co-morbidities that increase the risk of poor initial results or the risk of emergency bypass surgery (diabetes
mellitus, renal failure, and severe obesity) should be reviewed.
Thrombosis following stent implantation is affected by several baseline angiographic and procedural factors.
These include vessel diameters less than 2.0 mm, intra-procedural thrombosis, poor distal flow, and/or
dissection following stent implantation. In patients that have undergone coronary stenting, the persistence
of the thrombus or dissection is considered a marker for subsequent thrombotic occlusion. These patients
should be monitored very carefully during the first month after stent implantation.
When the DESyne NECSS is used off-label (i.e. outside of the approved indications for use), patient
outcomes may not be the same as the results observed in the clinical trials conducted to support marketing
approval.
8.2
Use in Specific Patient Populations
The safety and effectiveness of the DESyne NECSS have not been established in patients with:
• Unresolved thrombus at the lesion site.
• A coronary artery reference vessel diameter < 2.5 mm.
• A lesion located in the left main coronary artery, ostial lesions or lesions located at a bifurcation.
• Diffuse disease, or poor outflow distal to the identified lesions.
• >2 overlapping stents (due to risk of thrombosis and restenosis).
The safety and effectiveness of using mechanical atherectomy devices (directional atherectomy catheters,
rotational atherectomy catheters) or laser angioplasty catheters to treat in-stent restenosis have not been
established.
9.0
CLINICIAN USE INFORMATION
9.1
Materials Required
• Appropriate guiding catheter(s) (5F or 0.058” ID minimum)
• 2-3 syringes
• Heparinized normal sterile saline
• 0.014 inch (0.36 mm)(maximum OD) x 175 cm (minimum length) guide wire
• Rotating hemostatic valve
• 60% contrast diluted 1:1 with normal saline
• Inflation device
• Three-way stopcock
• Torque device
• Guide wire introducer
9.2
Packaging Removal
9.2.1 Tear open the foil pouch to reveal the non-sterile inner Tyvek pouch.
9.2.2 Remove the inner pouch from the outer foil pouch and carefully inspect the inner pouch for damage.
Do not use if the package has been damaged or opened.
9.2.3 Peel open inner pouch using aseptic technique to reveal the sterile catheter.
9.2.4 Pass or drop the sterile catheter into the sterile field using aseptic technique.
9.3
Inspection Prior to Use
• Remove the stent system from the hoop.
• Prior to use, carefully inspect the catheter for kinks, bends or other damage. Do not use if damage is
noted or if the device is inadvertently contaminated.
• Verify that the stent is located between the radiopaque markers on the balloon.
9.4
Preparation of Delivery System
9.4.1 Prepare the guiding catheter, guide wire and inflation device according to the manufacturer’s
instructions.
9.4.2 Carefully remove the protective sheath covering the stent/balloon segment.
9.4.3 Flush the stent system with heparinized saline using the flushing needle.
Caution
:
Avoid manipulation of the stent during flushing of the guidewire lumen, as this may
disrupt the placement of the stent on the balloon.
9.4.4 Fill a 20 cc syringe with 5 cc of contrast/heparinized normal saline mixture (1:1).
9.4.5 Attach to the delivery system proximal hub and apply negative pressure for 10 seconds.
9.4.6 With the syringe tip pointing downwards, slowly release pressure to neutral.
9.4.7 Attach a prepared inflation device to the catheter hub, leave on neutral pressure.
Caution: Do not apply negative pressure on inflation device during delivery of the stent to the
lesion site.
9.5
Delivery Procedure
9.5.1 Prepare vascular access site according to standard practice.
9.5.2 Pre-dilate the lesion site using a balloon that is shorter than the stent length.
9.5.3 While maintaining neutral pressure on the inflation device, backload the delivery system onto to the
guidewire.
9.5.4 Fully open the rotating hemostatic valve to allow easy passage of the stent and delivery system.
Note: If resistance is felt at any time, determine the cause of resistance before proceeding and
as necessary follow the Stent Removal Precaution instructions.
9.5.5 Tighten hemostatic valve and advance the stent system over the guidewire to the lesion site while
maintaining stable guide catheter and guidewire positioning.
9.6
Stent Deployment
9.6.1 Prior to stent expansion, reconfirm the location of the stent in relation to the balloon markers using
high-resolution fluoroscopy.
9.6.2 Under fluoroscopic guidance, inflate the stent system to the nominal pressure or until the stent appears
fully expanded. Maintain pressure for 15 – 30 seconds. Optimal expansion requires the stent to be
in full contact with the vessel wall, with the inner diameter of the stent matching the reference vessel
diameter.
Note: Do not exceed the Rated Burst Pressure. Do not expand the stent beyond 0.5 mm of the
nominal diameter.
9.6.3 If further dilatation of the deployed stent is required, a larger diameter, non-compliant balloon of a
length shorter than the deployed stent may be used. Avoid disruption of the stent when crossing the
newly deployed stent with the balloon catheter.
9.7
Removal Procedure
9.7.1 Ensure the balloon is fully deflated before attempting to withdraw the delivery system. Depending on
device size and contrast brand and dilution, this may take up to 30 seconds.
9.7.2 Withdraw the delivery system while maintaining guidewire placement.
9.7.3 Repeat angiography to assess the stented area. If adequate expansion has not been achieved follow the
instructions under Stent Deployment.
Ensure the stent is not under dilated.
9.8
Stent /System Removal – Precautions
Should
any resistance
be felt
at
any time
during either lesion access or removal of the stent delivery
system pre-implantation,
remove the delivery system as a single unit.
• 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 stent delivery system to the guiding catheter, and then
remove the guiding catheter and stent system as a single unit.
