SINEW Sirolimus Eluting Coronary Stent System

Surgical Technique

1. Device Description:
The Sinew Sirolimus Eluting Coronary Stent System comprises of following components.
1. L605 Cobalt Chromium alloy stent
2. Balloon Catheter (Stent is Pre mounted on balloon catheter between two platinum iridium
radio opaque marker bands)
3. Polymers (Drug Carrier)
4. Drug Sirolimus

Device component Description Sinew Sirolimus Eluting Coronary Stent System

Available stent lengths (mm): 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Available stent diameters (mm): 2.00, 2.25, 2.50. 2.75, 3.00, 3.50, 4.00, 4.50
Delivery System Usable Length: 140cm
Stent Delivery Balloon: Polyamide balloon, nominally 0.5 mm longer than stent. Mounted
stent length and location is defined by radio opaque marker.
Balloon inflation Pressure: Nominal Inflation Pressure: 9 atm
Rated Burst Pressure: 16 atm
Guiding catheter inner Diameter: 5 Fr (1.4mm) Compatible
• Drug Component Description
The stent component of the Sinew Sirolimus Eluting Coronary Stent System is a stent with
a drug & polymer coating formulation consisting of Sirolimus (the active ingredient), and
polymer (the inactive ingredient).
• Polymer
Lactide based Biodegradable polymers degrade after the drug is utilized and hence acts as
an excellent drug elution control media.
• Sirolimus
Sirolimus is a naturally occurring antimicrobial compound. It was first isolated from a soil
micro-organism on Easter Island in 1975.The chemical name (IUPAC) of Sirolimus is
Rapamune, 1,18-dihydroxy-12- [2-(4-hydroxy-3-methoxy-cyclohexyl) -1-methyl-ethyl] -
19,30-dimethoxy-15, 17,21 ,23,29,35 -hexamethyl-11, 36-dioxa-4-aza-tricyclo

Veritas Bioventions Pvt. Ltd.

Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

[30.3.1.0%4,9&] hexatriaconta-16, 24,26,28-tetraene-2, 3,1 0,14,20-pentaone. lts molecular

formula is C51 H79N013 and its molecular weight mass is 914.2 a.m.u.
Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl
alcohol, chloroform, acetone, and acetonitrile. and has a melting temperature of
approximately 183-185°C.
Refer to Table 1.1 for the nominal dosage of Sirolimus on SiNew Sirolimus Eluting Stent.

Drug content on the Sinew Sirolimus Eluting Coronary Stent System

Stent Length (mm) Sirolimus Drug Content (µg) 1.0 mcg/mm2
8 66 + 10%
12 94 ± 10%
16 122 + 10%
20 159 + 10%
24 187 ±10%
28 215 +10%
32 243 +10%
36 280 +10%
40 308 ±10%
44 336 +10%
48 364 +10%

2. Indications
The Sinew Sirolimus Eluting Coronary Stent System is indicated for improving coronary
luminal diameter in patients with symptomatic ischemic heart disease in de novo coronary
artery lesion in native coronary arteries with a reference vessel diameter of 2.00 mm to 4.50
mm and a lesion length ≤ 44 mm in patients eligible for percutaneous Transluminal
Coronary Angioplasty (PTCA).

Veritas Bioventions Pvt. Ltd.

Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

3. How Supplied:
Sterile: This device is sterilized with EO, Non pyrogenic.
Do not use if the package is opened or damaged.
Contents: One (1) Sinew Sirolimus Eluting Coronary Stent System.
Storage: Store at 2°C to 25°C, dry, dark place
4. Contraindications
Use of Sinew Sirolimus Eluting Coronary Stent System is contraindicated in the following
patient types:
a. Patients who are not candidates for coronary bypass surgery.
b. Target lesions involving a major side branch.
c. Patients who exhibit angiographic evidence of existing thrombus.
d. Person's allergic to L605 Cobalt Chromium alloy & Sirolimus.
e. Patients with a contraindication for anti- platelet / anti - coagulant therapy, this includes
patients who have had major surgery, an obstetrical delivery organ biopsy, or puncture of a
non-compressible vessel within 14 days of this procedure. Also excluded are those patients
with a history of gastrointestinal bleeding, recent C.V.A., diabetic haemorrhagenic
retinopathy, or any condition compromised by prolonged anti- coagulant.
f. Pregnant women or women of childbearing potential.
g. Patients who have experienced a recent (less than 1 week) acute myocardial infarction.
h. Patients with diffuse disease, defined as long segments of abnormal vessel without
interposed normal vessel.
I. Transplant patients.
5. Precautions
Only physicians who have received adequate training should perform implantation of the
stent. Stent placement should only be performed at hospitals where emergency coronary
bypass graft surgery can be readily performed. Note the "Expiry" date on the product label.
Do not resterilise or reuse, product is intended for Single use only.
Do not remove the stent from the delivery balloon as removal may damage the stent and /
or lead to stent embolization. The stent system is intended to perform as a system.

Veritas Bioventions Pvt. Ltd.

Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

The Sinew Sirolimus Eluting Coronary Stent System is intended to perform as a system.
The stent should not be removed for use in conjunction with other dilatation catheters, nor
should the Sinew Sirolimus Eluting Coronary Stent System be used in conjunction with
other Stents.
Guiding catheters used must have lumen sizes that are suitable to accommodate the
introduction of Sinew Sirolimus Eluting Coronary Stent System
Use only the appropriate balloon inflation media. Do not use any gaseous medium to inflate
the balloon as this may cause uneven expansion and difficulty in deployment of the stent.
Do not expand the stent if it is not properly positioned in the vessel.
Don't exceed the maximum rated pressure.
To avoid the possibility of dissimilar metal corrosion, do not implant Stents of different
materials in tandem overlap or contact if possible.
Subsequent blockage may require repeat dilatation of the arterial segment containing the
stent. Should unusual resistance be felt at any time during either lesion access or removal
of the Delivery System post-stent implantation, the entire system should be removed as a
single unit.
The safety and effectiveness of the Sinew Sirolimus Eluting Coronary Stent System in
patients with prior Brachytherapy of the target lesion have not been established
The safety and effectiveness of using mechanical atherectomy devices or laser angioplasty
catheters in conjunction with Sinew Sirolimus Eluting Coronary Stent System implantation
have not been established
MRI scan should not be performed on patients after implantation until there is adequate
neoinitimal investment on the stent to minimize the potential stent migration.
6. Clinical Procedures:
The following instructions provide guidance but not obviate the necessity of training in the
use of the device.
The stenting procedures should be done according to standard PTCA guidelines.
Open product box to remove the inner pouch containing sterile stent delivery system.
Remove inner pouch from product box.
Peel open inner pouch using aseptic technique to reveal sterile package.
Veritas Bioventions Pvt. Ltd.
Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

Prior to using Sinew Sirolimus Eluting Coronary Stent System, carefully inspect for bends,
kinks, and other damage. Verify that the stent is located between the radio opaque balloon
markers.
Do not use if there is any damage to the packaging and labeling.
Flush guide wire lumen with HepNS until fluid exits guide wire exit notch.
Special care must be taken not to handle or in any way disrupt the stent on the balloon.
This is most important during stent system removal from the packaging, placing it over the
guide wire, and advancement through the rotating haemostatic valve adaptor and guiding
catheter hub.
In an event when Sinew Sirolimus Eluting Coronary Stent System is not deployed, follow
product return procedures and avoid handling of the stent with hands.
Do not prepare or pre-inflate balloon prior to stent deployment other than as directed.
When treating multiple lesions, the distal lesion should be initially stented, followed by
stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal
stent in placement of the distal stent and reduces the chances for dislodging the proximal
stent.
Attach a syringe filled with 50 % contrast / 50 % saline and apply negative pressure for 10
to 15 seconds. Return to neutral pressure to allow the contrast mixture to flow into the
balloon. Repeat this until there are no air bubbles left. Attach a prepared inflation device to
the catheter.
Predilate the lesion with PTCA catheter.
Expand the stent by inflating the balloon to the recommended inflation pressure for 15 to 30
seconds.
(Ref. Compliance Chart, Table 8.1)
Deflate the balloon and verify with angiography that the stent is fully expanded. If the stent
is not fully expanded, re-inflate the balloon till the optimal result is not obtained.
Deflate balloon by pulling negative on inflation device for 30 seconds.
After angiography conformation of complete and adequate stent expansion, remove both
delivery catheter and guiding catheter through the introducer sheath.
Note: Updated guidelines for the procedure have to be consulted through new publication.
Veritas Bioventions Pvt. Ltd.
Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

7. Adverse effects:
Potential adverse events, which may be associated with the use of a coronary stent, include
but are not limited to:
Abrupt stent closure, Acute myocardial infarction, Angina.
Allergic reactions to anti - coagulant and or antithrombotic therapy or contrast medium.
Arrhythmia, including ventricular fibrillation (VF) and ventricular tachycardia (VT)
Arterial perforation, Arterial rupture, Arteriovenous fistula.
Bleeding complications, Bradycardia.
Cardio tamponade, Cardiogenic shock, Coronary spasm
Coronary or stent embolism, Coronary or stent thrombosis.
Dissection of the coronary artery, Death.
Drug reactions to antiplatelet agents / anticoagulation agents / contrast medium.
Emboli, distal (air, tissue or thrombotic emboli)
Emergency or non - emergent Coronary Artery Bypass Graft Surgery.
Entry site complications, Heart Failure, Hematoma.
Hemorrhage, requiring transfusion, Hypotension / Hypertension.
Infection and / or pain at the access site.
Injury to the coronary artery, Ischemia, Nausea and vomiting.
Palpitations, Perforation or rupture.
Pericardial effusion, Pseudoanerusym, femoral.
Renal failure, Respiratory failure, Restenosis of stented segment, Rhythmical disturbances.
Shock / Pulmonary edema, Spasm, Stroke / cerebovascular accident / TIA.
Total occlusion of coronary artery.
Unstable angina pectoris.
Vascular complications, which may require vessel repair.
Ventricular fibrillation.
Possible risks and side effects can occur due to the coating of the stent with Sirolimus. The
following risks were observed when Sirolimus was given to patients at a dose appropriate
for its normal indication:
Abnormal liver function tests
Veritas Bioventions Pvt. Ltd.
Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

Anemia, Arthralgias, Diarrhea

Hypercholesterolemia
Hypersensitivity, including anaphylactic/anaphylactoid type reactions
Hypertriglyceridemia
Hypokalemia, Infections
Interstitial lung disease
Leukopenia, Lymphoma and other malignancies
Thrombocytopenia
8. In Vitro Information:
Table 8.1 Stent diameter (measured at 37°C Tolerance ± 0.10mm)
SINEW Sirolimus Eluting Coronary Stent System
Pressure (Bar) 2.00 2.25 2.50 2.75 3.00 3.50 4.00 4.50
6 1.92 2.11 2.35 2.58 2.80 3.25 3.85 4.41
7 1.94 2.16 2.40 2.64 2.90 3.30 3.90 4.43
8 1.96 2.21 2.46 2.71 2.94 3.40 3.95 4.45
9(NP) 2.00 2.25 2.50 2.75 3.00 3.50 4.00 4.50
10 2.04 2.34 2.60 2.81 3.07 3.54 4.04 4.52
11 2.08 2.38 2.64 2.86 3.10 3.58 4.08 4.55
12 2.10 2.42 2.68 2.91 3.14 3.62 4.12 4.58
13 2.13 2.44 2.70 2.95 3.18 3.66 4.16 4.60
14 2.16 2.46 2.72 2.98 3.20 3.70 4.20 4.62
15 2.18 2.48 2.74 3.01 3.22 3.74 4.24 4.64
16 2.20 2.50 2.76 3.04 3.24 3.78 4.28 4.67
17 2.22 2.54 2.80 3.07 3.27 3.82 4.32 4.71
18 2.24 2.56 2.82 3.10 3.35 3.86 4.36 4.75
Grey background: NP (Nominal Pressure),
Black background: RBP(Rated Burst Pressure)

Veritas Bioventions Pvt. Ltd.

Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
 SINEW Sirolimus Eluting Coronary Stent System
Surgical Technique

9. Disposal of Used and Unused Product :

After use, dispose off product and packaging in accordance with hospital, administrative
and/or local government policy. If product is unused, return it to manufacturer for disposal
10. Disclaimer of Warranty and Limitation of remedy:
There is no express or implied warranty, including without limitation any implied warranty of
merchantability of fitness for a particular purpose, on the Veritas Bioventions Pvt. Ltd.
product(s) described in this publication. Under no circumstances shall Veritas Bioventions
Pvt. Ltd. be liable for any direct, indirect, incidental or consequential damages other than as
expressly provided by specific law. No person has the authority to bind Veritas Bioventions
Pvt. Ltd. to any representation or warranty except as specifically set forth herein.
Descriptions or specifications in Veritas Bioventions Pvt. Ltd. printed matter, including this
publications, are meant solely to generally describe the product at the time of manufacture
and do not constitute any express warranties.
Veritas Bioventions Pvt. Ltd. will not be responsible for any direct, indirect, incidental, or
consequential damages resulting from reuse of the product.

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Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.
T: +91 260 2424552 – 2424553 F: +91 2602424553
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Veritas Bioventions Pvt. Ltd.

Factory: Plot No. 5305, 4th Phase, G.I.D.C., Vapi-396 195. Gujarat, India.