Warning; Device Description; Device Component Description; Contents - Boston Scientific SYNERGY Mode D'emploi

SYNERGY
™
m o n o r a i l ™
Everolimus-Eluting Platinum Chromium
Coronary Stent System
ONLY
caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

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.
After use, dispose of product and packaging in accordance with hospital, administrative and/
or local government policy.

DevIce DescrIptIon

The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent
System) is a device/drug combination product comprised of two regulated components: a
device (coronary stent system) and a drug product (a formulation of everolimus contained in
a biodegradable polymer coating). SYNERGY is uniquely designed with a low initial polymer
load, abluminal coating and bioabsorbable polymer which may reduce the risk of thrombosis
and the need for prolonged dual antiplatelet therapy. The characteristics of the SYNERGY
Stent System are described in Table 1. SYNERGY Stent System Product Description.
table 1. synerGy stent system product Description
characteristic
Available stent lengths (mm) 8, 12, 16, 20, 24, 28, 32, 38
Available stent diameters (mm) 2.25, 2.50, 2.75, 3.00, 3.50, 4.00
Stent material Platinum Chromium (PtCr) Alloy
An abluminal (outer surface of the stent) coating of a polymer
carrier with approximately 1 μg of everolimus per mm
Drug product stent surface area and a maximum nominal polymer content of
351 μg and drug content of 287 μg on the largest stent
(4.00 x 38 mm)
Delivery system effective length 144 cm
Single access port to inflation lumen.
Delivery system Y-adapter ports Guidewire exit port is located approximately 25 cm from tip.
Designed for guidewire ≤ 0.014 in (0.36 mm).
Average stent length change Small Vessel (SV) average: -0.15 mm
upon deployment at nominal Workhorse (WH) average: -0.20 mm
diameter Large Vessel (LV) average: 0.15 mm
A balloon with two radiopaque markers nominally 0.4 mm
Stent delivery balloon
longer than the stent at each end.
synerGy stent system
of total
2
characteristic
Nominal inflation pressure: 11 atm (1117 kPa)
Rated burst pressure:
Balloon inflation pressure
2.25 - 2.75 mm: 18 atm (1827 kPa)
3.00 - 4.00 mm: 16 atm (1620 kPa)
Guide catheter inner diameter ≥ 0.056 in (1.42 mm)
Proximal: 2.1F (0.70 mm)
Distal:
2.25 - 2.75 mm: 2.6F (0.90 mm)
3.00 mm:
• 8 - 28 mm: 2.6F (0.90 mm)
Catheter shaft outer diameter
• 32 - 38 mm: 2.7F (0.95 mm)
3.50 mm:
• 8 - 20 mm: 2.6F (0.90 mm)
• 24 - 38 mm: 2.7F (0.95 mm)
4.00 mm: 2.7F (0.95 mm)
2.25 - 2.75 mm: 0.074 mm
Stent strut thickness 3.00 - 3.50 mm: 0.079 mm
4.00 mm: 0.081 mm

Device component Description

The SYNERGY Stent System consists of a platinum chromium stent platform with an abluminal
drug/polymer coating mounted onto a Monorail Delivery System.
The SYNERGY stent is available in 3 stent models each designed for specific diameters as
follows:
• Small Vessel (SV): 2.25, 2.50 and 2.75 mm
• Workhorse (WH): 3.00 and 3.50 mm
• Large Vessel (LV): 4.00 mm

contents

Qty Material
One (1) SYNERGY Stent System
One (1) Flushing needle with Luer fitting

Drug eluting coating Description

The SYNERGY stent is a stent with a drug/polymer coating. The coating is comprised of a
polymer matrix that contains an active pharmaceutical ingredient.
See everolimus and polymer carrier sections for descriptions of drug and polymer, respectively.

everolimus

Everolimus is the active pharmaceutical ingredient in the SYNERGY stent.
The everolimus chemical name is 42-O-(2-hydroxyethyl)-rapamycin, and its chemical structure
is shown below in Figure 1.
figure 1. the chemical structure of everolimus
3
synerGy stent system
Black (K) ∆E ≤5.0