Polymer Carrier; Product Matrix; Intended Use/Indications For Use; Contraindications - Boston Scientific SYNERGY Mode D'emploi

polymer carrier

The SYNERGY™ stent is coated on the abluminal stent surface with a biodegradable drug
matrix. The biodegradable drug matrix is composed of PLGA [poly(DL-lactide-co-glycolide)]
mixed with everolimus. The chemical structure of PLGA is shown below in Figure 2.
figure 2. the chemical structure of pLGa

product Matrix

table 2. synerGy stent system product Matrix and everolimus content
nominal expanded
Upn number
Inner Diameter (mm)
H7493926208220 2.25
H7493926208250 2.50
H7493926208270 2.75
H7493926208300 3.00
H7493926208350 3.50
H7493926208400 4.00
H7493926212220 2.25
H7493926212250 2.50
H7493926212270 2.75
H7493926212300 3.00
H7493926212350 3.50
H7493926212400 4.00
H7493926216220 2.25
H7493926216250 2.50
H7493926216270 2.75
H7493926216300 3.00
H7493926216350 3.50
H7493926216400 4.00
H7493926220220 2.25
H7493926220250 2.50
H7493926220270 2.75
H7493926220300 3.00
H7493926220350 3.50
H7493926220400 4.00
H7493926224220 2.25
H7493926224250 2.50
H7493926224270 2.75
H7493926224300 3.00
H7493926224350 3.50
Black (K) ∆E ≤5.0
nominal Unexpanded nominal everolimus
stent Length (mm) content (µg)
8 38.9
8 38.9
8 38.9
8 46.5
8 46.5
8 67.5
12 58.3
12 58.3
12 58.3
12 66.3
12 66.3
12 96.2
16 77.6
16 77.6
16 77.6
16 92.7
16 92.7
16 124.8
20 96.9
20 96.9
20 96.9
20 112.5
20 112.5
20 153.5
24 121.1
24 121.1
24 121.1
24 132.3
24 132.3
nominal expanded
Upn number
Inner Diameter (mm)
H7493926224400 4.00
H7493926228220 2.25
H7493926228250 2.50
H7493926228270 2.75
H7493926228300 3.00
H7493926228350 3.50
H7493926228400 4.00
H7493926232220 2.25
H7493926232250 2.50
H7493926232270 2.75
H7493926232300 3.00
H7493926232350 3.50
H7493926232400 4.00
H7493926238220 2.25
H7493926238250 2.50
H7493926238270 2.75
H7493926238300 3.00
H7493926238350 3.50
H7493926238400 4.00

IntenDeD Use/InDIcatIons for Use

The SYNERGY Stent System is indicated for improving coronary luminal diameter in patients with
symptomatic ischemic heart disease, including patients with acute myocardial infarction (AMI),
due to discrete de novo native coronary artery lesions. The treated lesion length should be less
than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm and 38 mm)
with a reference vessel diameter of 2.25 mm - 4.0 mm.

contraInDIcatIons

Use of the SYNERGY Stent System is contraindicated in patients with the following:
• Known hypersensitivity to platinum, the platinum chromium alloy, or similar alloy types
such as stainless steel.
• Known hypersensitivity to everolimus or structurally related compounds.
• Known hypersensitivity to the polymer or its individual components (see details in
polymer carrier).
• Known severe reaction to contrast agents that cannot be adequately pre-medicated prior
to the SYNERGY stent placement procedure.
Coronary artery stenting is contraindicated for use in the following:
• Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty
balloon or proper placement of the stent or delivery device.

warnInGs

• This product should not be used in patients who are not likely to comply with
recommended anti-platelet therapy.
• To maintain sterility, the package should not be opened or damaged prior to use. The
package should be opened as described in operational Instructions.
• The use of this product carries the risks associated with coronary artery stenting,
including stent thrombosis, vascular complications, and/or bleeding events.
4
nominal Unexpanded nominal everolimus
stent Length (mm) content (µg)
24 182.2
28 140.5
28 140.5
28 140.5
28 158.7
28 158.7
28 210.8
32 159.8
32 159.8
32 159.8
32 178.5
32 178.5
32 239.5
38 188.9
38 188.9
38 188.9
38 211.6
38 211.6
38 287.2