Celosia

Covered Coronary Stent

INSTRUCTIONS FOR USE

IFU1062 Rev. B 10/22/2016

Celosia
Covered Coronary Stent
INSTRUCTIONS FOR USE
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
1.0 DEVICE NAME
The device brand name is Celosia Covered Coronary Stent System.
2.0 DESCRIPTION
The Celosia Covered Coronary Stent System is an emergency use covered stent pre-mounted on balloon
delivery catheter distal tip. The principal mechanism of action for The Celosia Covered Stent is inflation to the
balloon via an inflation device. The Celosia Covered Coronary Stent System is packaged sterile and intended
for single use only.
Stent Platform:
The stent is provided in a range of sizes from diameters 2.07.0mm, and lengths of 05-38mm. The Celosia
Covered Stent is based on the patented intravascular stent design. The alloy is medical grade L605 Cobalt
Chromium Alloy.
Delivery Catheter:
The delivery system consists of a balloon-expandable Direct-Stent Stent Graft premounted on balloon delivery
catheter distal tip. The delivery system has two radiopaque markers located underneath the balloon, which
during fluoroscopy; mark the working length of the balloon and aid in placement of the stent. The stent de
livery system is compatible with a 0.014" (0.36mm) guidewire and a 5 -6F guide catheter (dependent on the
diameter).
A rigid connector is used at the end of the proximal part. This hub has a female luer lock connector enabling
connection with other medical devices in order to permit the inflation of the balloon with an inflation media.
Polymer:
The ePTFE polymer consists of 100% virgin homopolymer. The polymer is extruded from resin into a membrane
that is wrapped to form a tube. The method of manufacture produces an inherently high strength tube
considering the extremely thin wall. The polymer is then heat treated at very high temperature. The porosity of
the polymer and the lattice structure is proprietary including the manufacturing process.
CONTENTS
1 Celosia Covered Coronary Stent System
1 Instruction for Use
HOW SUPPLIED

G
IQ
D
B

STERILE
Sterilized with ethylene oxide gas (EtO)
FOR SINGLE USE ONLY
DO NOT RESTERILIZE

Storage:

w
p
L

Keep from Sunlight

Keep Dry
Do not use if the package has been opened or damaged

IFU1062 Rev. B 10/22/2016

Storage (cont.):

H
30:
15:l

Use by the Use By date noted on the package

Use only between 15 C and 30 C

3.0 INDICATIONS FOR USE

The Celosia Covered Stent is indicated for use in the treatment of free perforations, defined as free contrast
extravasation into the coronary vasculature, in native coronary vessels >2.0mm in diameter.
4.0 CONTRAINDICATIONS
CONTRAINDICATIONS

The Celosia Cobalt Chromium Alloy Coronary Stent System is contraindicated for use in:
Patients with a documented previous Q-wave myocardial infarction in the territory supplied by the vessel to
be stented.
Any myocardial infarction within 7 days of the intended procedure.
Patients with Braunwald Class 3 A-B-C angina pectoris.
Left ventricular fraction estimated to be <30%, or cardiogenic shock.
Contraindication to an emergency coronary bypass surgery.
With a lesion judged to prevent complete inflation of an angioplasty balloon.
In whom antiplatelet and/or anticoagulation therapy is contraindicated.
Who would be considered unsuitable candidates for standard PCI.
With a known hypersensitivity or allergy to stent coating materials or to L605 Cobalt Chromium Alloy.
Since the use of this device carries the associated risk of subacute thrombosis, vascular complications and/or
bleeding events, judicious selection of patents is necessary. There may be higher risks for:
Patients who exhibit angiographic evidence of existing thrombus.
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 hemorhagenic retinopathy, or any other condition compromised by prolonged anticoagulation.
Pregnant women or women of childbearing potential.
Target lesions distal to previously placed stents.
Target lesions in an area involving a major side branch. A major side branch is defined as a vessel that would
be bypassed if it were occluded.
Persons allergic to L605 Cobalt Chromium Alloy
may suffer an allergic reaction to this implant.
Patients who have experienced a recent (less that 1 week) acute myocardial infarction.
a. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the
diameter of the vessel just proximal and distal to the stenosis.
b. Stenting in patients who are not acceptable candidates for coronary artery bypass surgery requires
careful consideration, including possible hemodynamic support during stenting, as treatment of this
patient population carries special risk.
>90 degrees, two sequential bends >60 degrees.
THE USE OF ADJACENT STENTS OF DIFFERENT METAL TYPES IS CONTRAINDICATED.
5.0 COMPLICATIONS
The following complications may be associated with the use of The Celosia Covered Coronary Stent System in
native coronary arteries:
Acute myocardial infarction
Arrhythmias (including VF and VT)
Coronary Artery Bypass Surgery
Death
Dissection
Drug reactions to antiplatelet agents/contrast medium
Emboli, distal (air, tissue or thrombotic emboli)
IFU1062 Rev. B 10/22/2016

Emergent Coronary Artery Bypass Surgery

Hemorrhage, requiring transfusion
Hypotension/Hypertension
Infection and pain at insertion site
Ischemia, myocardial
Perforation
Pseudoaneurysm, femoral
Restenosis of stented segment
Spasm
Stroke/Cerebrovascular Accidents
Total occlusion of coronary artery

6.0 PRECAUTIONS
Use of this device may carry the associated risks of subacute thrombosis, vascular complications and/or
bleeding events. It is recommended that inclusion of patients to receive this device should conform with the
indications/contraindications described previously. The risk of subacute thrombosis may increase when multiple
overlapping stents are used.
Infection secondary to contamination of the stent may lead to thrombosis, pseudo aneurysm or rupture. The
metal stent may lead to spasm, distal embolism, and thrombus. Excessive stretching of the artery may cause
rupture and life threatening bleeding.
The implantation of the stent should be performed only by physicians who have received adequate training
in stent placement.

MAGNETIC RESONANCE IMAGING

A magnetic resonance imaging scan should not be performed until the implanted stent has been
completely endothelialised (eight weeks) in order to minimize the risk of the stent migrating under the strong
magnetic field.
A cardiac surgery team should be available while stent implantation is being performed.
Prior to the procedure, the stent system should be visually examined to verify functionality and ensure that its
size is suitable for the specific procedure for which it is to be used.
Only physicians thoroughly trained and experienced in the performance of percutaneous coronary
transluminal angioplasty (PTCA) and stent implantation should use this device.
PTCA and stent implantation should only be performed at hospitals where emergency coronary artery
bypass can be readily performed in the event of a potential injury or life-threatening complication.
Exercise care during device handling to reduce the possibility of disrupting the delicate placement of the
stent on the balloon and accidental breakage, bending or kinking of the stent system shaft.
Use only guidewires with a diameter of 0.014 (0.36mm).
Use guiding catheter with a minimum inner diameter compatible with the diameter of the Celosia.
Reference the specification table at the end of the IFU for guide catheter compatibilities by diameter.
Ensure that the guidewire exit port remains inside the guiding catheter at all times, Guide wire exit port is
indicated on the in the schematic at the end of the IFU.
The use of mechanical atherectomy devices or laser catheters is not recommended in the stented area.
Narrow, calcified and tortuous lesions or other lesions that could impede the delivery of the stent must be
pre-dilated with an appropriately sized angioplasty balloon or ore-treated with another method before using
the
Celosia Covered Stent is indicated for use in the treatment of free perforations, defined as free contrast
extravasation into the coronary vasculature, in native coronary vessels >6mm in diameter.
Take care when removing the stent system from the spiral packaging, as forceful movements may dislocate
the protector and the stents.
When removing the stent protector, always pull at the very distal end of the protector to avoid dislocation of
the stent.
Avoid excessive manipulation of the stent during flushing of the guidewire lumen.
DO NOT apply negative pressure to the stent system at any time prior to placement of the stent across the
lesion; this may cause premature dislodgement of the stent.
When inserting and positioning the stent system, ensure that the hemostatic valve of the guiding catheter is
fully open. A partially opened hemostatic valve might damage the stent or dislodge it from the centered
location on the balloon.

IFU1062 Rev. B 10/22/2016

 DO NOT apply excessive force whilst accessing or crossing the lesion. This may damage the stent and/or
dislodge it from the balloon. If resistance is felt at any time, stop the procedure and determine the cause of
resistance before proceeding. If the stent system is unable to reach or cross the lesion easily, the procedure
should be aborted. Refer to the section Removal of an unexpanded stent .
DO NOT apply excessive force while attempting to cross the lesion. This may damage the stent and/or
dislodge it from the balloon. If the stent system is unable to cross the lesion easily the unexpanded stent
should be removed according to the instructions.
DO NOT inflate the balloon if a vacuum cannot be held, as this indicates a leak in the delivery system.
Avoid barotrauma outside the stent margins during post-dilatation.
DO NOT post-dilate the stent to more than the maximum expandable diameter recommending the
compliance table.
Exercise care when crossing a newly deployed stent with a 2guidewire, balloon catheter or stent system to
avoid disruption of the stent geometry and stent migration.
If resistance is encountered during removal of the delivery system, remove the delivery system and the
guiding catheter as a single unit according to the instructions below.
DO NOT RE-INSERT The Celosia Covered Stents the stent and/or the delivery system may have been
damaged during the initial attempt to cross the lesion or during withdrawal.
Failure to follow correct removal steps for an unexpanded stent system and/or applying excessive force to
the stent system=n can potentially result in loss or damage to the stent and/or delivery system components.
Disposal of packaging materials can be handled per normal industrial/local standards. The used device shall
be handled according to hospital procedure.
6.1 STENT HANDLING - PRECAUTIONS
Do not remove the stent from its Balloon Catheter Delivery System. Removing the stent from its delivery
balloon may damage the stent and/or lead to stent embolization.
Special care must be taken not to handle or in any way disrupt the stent position on the delivery device. This
is most important during placement over the guidewire and advancement through the hemostasis valve
adaptor and guiding catheter hub.
Excessive manipulation (e.g., rolling the mounted stent) may cause dislodgment of the stent from the
delivery balloon or may damage the balloon catheter.
Use only appropriate balloon inflation media. Do not use air or any gas medium to inflate the balloon as it
may cause uneven expansion and difficulty in deployment of the stent.
6.2 STENT PLACEMENT - PRECAUTIONS
Do not prepare or pre-inflate the balloon prior to stent deployment other than as directed. Use standard
angioplasty balloon purging technique to prepare the system.
Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stent, and may cause
acute closure of the vessel requiring additional intervention (e.g., CABG, further dilatation, placement of
additional stents, or other).
If more than one stent is required, the distal stent should be placed initially, followed by placement of the
proximal stent. Stent placement in this order obviates the need to cross the proximal stent when placing the
distal stent, and reduces the chances for dislodging the proximal stent.
Do not expand the stent if it is not properly positioned in the vessel (See Stent /System Removal - Precautions)
Placement of the stent will compromise side branch patency.
Balloon pressures should be monitored during inflation. Do not exceed rated burst pressure as indicated on
the product label. Use of pressures higher than specified on the product label may possibly result in a
ruptured balloon and potential intimal damage and dissection.
Do not attempt to pull an unexpanded stent back through the guiding catheter; dislodgment of the stent
from the balloon may occur. (See stent /System Removal - Precautions)
Stent retrieval methods (use of additional wires, snares, and/or forceps) may result in additional trauma to
the vascular access site. Complications may include bleeding, hematoma, or pseudoaneurysm.
6.3 STENT /SYSTEM REMOVAL - PRECAUTIONS
Should unusual resistance be felt at any time, either during lesion access or during removal of the Delivery
System post-stent implantation, the Delivery System and guiding catheter should be removed as a single unit.
This must be done under direct visualization of fluoroscopy. When removing the Delivery System as a single unit:

IFU1062 Rev. B 10/22/2016

 It's recommended maintaining guidewire placement across the lesion and carefully pulling back the
delivery system until the proximal balloon marker of the delivery system is aligned with the distal tip of the
guiding catheter. Do not pull the Delivery System into the guiding catheter.
The guiding catheter and Stent Delivery system should be carefully removed from the coronary artery as a
single unit.
The system should be pulled back into the descending aorta toward the arterial sheath. As the distal end of
the guiding catheter enters into the arterial sheath, the catheter will straighten allowing safe withdrawal of
the Stent Delivery System into the guiding catheter, and the subsequent removal of the Stent Delivery System
from the arterial sheath.
Failure to follow these steps and/or applying excessive force to the Delivery System can potentially result in
loss or damage to the stent or Delivery System components such as the balloon. If it is necessary to retain
guidewire position for subsequent artery/lesion access, leave the guidewire in place and remove all the
other components
6.4 POST-STENT PLACEMENT - PRECAUTIONS
Care must be exercised when crossing a newly deployed stent with an intravascular ultrasound (IVUS), or a
coronary guidewire or balloon catheter to avoid disrupting the stent geometry.
6.5 Magnetic Resonance Imaging (MRI) safety information

MR Conditional
Non-clinical testing has demonstrated the Celosia Covered Stent is MR Conditional. A patient with this device
can be safely scanned in an MR system meeting the following conditions:
Static magnetic field of 1.5-Tesla, only
Maximum spatial gradient magnetic field of 4,000-guass/cm (40-T/m)(extrapolated) or less
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15
minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode of operation for the MR
system
Under the scan conditions defined about the Celosia Covered Stent is expected to produce a maximum
temperature rise of 2.3C after 15-minutes of continuous scanning (i.e., per pulse sequence).
7.0 WARNINGS

This device is intended for one time use only. DO NOT resterilize and/or reuse it, as this can potentially result
in compromised device performance and increased risk of inappropriate resterilization and cross
contamination. Contamination of the device creates risk for patient or user by means of infections and may
lead to injury, illness or death of the patient. Cleaning, disinfection and sterilization may compromise
essential material and design characteristics leading to device failure. InSitu Technologies will not be
responsible for any direct, incidental or consequential damages resulting from resterilization or reuse.

Use of this device may carry the associated risks of subacute thrombosis, vascular complications and/or
bleeding events. It is recommended that inclusion of patients to receive this device should conform to the
indications/contraindications described previously. The risk of subacute thrombosis may increase when
multiple overlapping stents are used. Infection secondary to contamination of the Stent may lead to
thrombosis, pseudo aneurysm or rupture. The metal stent may lead to spasm, distal embolism, and
thrombus. Excessive stretching of the artery may cause rupture and life threatening bleeding.

The Celosia Covered Coronary Stent System is indicated for use following PTCA and, in special patient
populations as described in the delivery procedure below, can be used without pre-dilatation. The systems
are for deployment and post-deployment dilatation of the stent only. They are not coronary dilatation
catheters, and should not be used to dilate other coronary lesions.

DO NOT use the stent system if the outer or if the inner package is damaged or opened.

DO NOT use device after the Use by date indicated on the label.

DO NOT attempt to remove or readjust the stent on the delivery system. The stent cannot be removed and
placed on another balloon catheter

DO NOT expose the stent system to organic solvents, e.g. alcohol.

Appropriate anticoagulant, antiplatelet and vasodilatation therapy should be administered to the patient.

When the stent system is in the body it should be manipulated while under high quality fluoroscopy.

When multiple stents are required to treat a lesion, stents should be of similar composition as the risk of
corrosion increases when stent of different metals contact one another.
IFU1062 Rev. B 10/22/2016

Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stent and may cause
acute closure of the vessel, requiring additional intervention (CABG, further dilatation, placement of
additional stents, or other).
To reduce the potential for vessel damage, the inflated diameter of the balloon should NEVER exceed the
original diameter of the vessel proximal and distal to the lesion.
Balloon pressures should be monitored during inflation. Do not exceed the rated burst pressure indicated on
the product label. Use of pressures higher than specified on product label may result in a ruptured balloon
with possible intima damage and dissection. The rated burst pressure is bases on the results of InVitro testing.
At least 99.9 percent of the balloons, (with a 95 percent confidence) will not burst at or below their rated
burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization. Should
dissection occur, deflate the balloon. If you experience resistance or difficulty removing the balloon
catheter through the guided catheter, discontinue pulling on the balloon catheter and remove the balloon
catheter, guidewire and guide catheter as a single unit.
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. Do not use with
Ethiodol or Lipiodol contrast media, or other such contrast media, which incorporates the components of
these agents.
Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The longterm outcomes following repeat dilatation of endothelialized stent are unknown.
Do not autoclave. Exposure to temperatures above 54C (130F) may damage the catheter.
Stents should not be placed within 2.0mm of origin of left anterior descending or circumflex artery, or within
2.0mm of an unprotected left main.
An unexpanded stent may be retracted into the guiding catheter one time only. Subsequent movement in
and out through the distal end of the guiding catheter should not be performed, as the stent may be
damaged when retracting the undeployed stent back into the guiding catheter. Should any resistance be
felt at any time during the withdrawal of the stent system, remove the entire system as a single unit.
Should any resistance be felt at any time during lesion access or delivery system removal, the entire guiding
catheter and stent system should be removed as a single unit. Applying excessive force to the stent delivery
system can potentially result in loss or damage to the stent and delivery system components.

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. Complications may include bleeding, hematoma or
pseudoaneurysm.
8.0 PREPARATION
PREPARATION
For preparation of the Celosia Covered Coronary Stent System, it is recommended that in addition to the
stent delivery catheter, the following equipment be assembled for use:
Guidewire (0.014)
PTCA Y-adapter: 1 Tuohy-Borst
Guidewire insertion tool
Balloon inflation device (i.e. an inflation device with a stopcock if desired and connector tubing)
Sterile bowl with heparinized flush solution
Sterile bowl with a 1:1 mixture of low viscosity contrast medium and sterile saline
10cc or larger plastic luer lock syringe (for stent delivery preparation)
Flushing tool
The lesion should be pre-dilated sufficiently to assure subsequent passage of the balloon/stent combination
STENT SYSTEM PREPARATION
CAUTION: Exercise care during device handling to reduce the possibility of disrupting the delicate placement of
the stent on the balloon and accidental breakage, bending or kinking of the stent delivery system shaft.
3

Remove the protection ring containing the stent system from the sterile package and place it onto a sterile
field.

Gently pull out the stent system from the protection ring.

IFU1062 Rev. B 10/22/2016

CAUTION: Forceful movements may dislocate the protector and the stent.
5

Carefully remove the balloon/stent protector.

CAUTION: Always pull at the very distal end of the protector to avoid dislocation of the stent.
6

Visually check the stent crimping for uniformity, no protruding struts, and centering on the balloon.

PRE-FLUSH GUIDEWIRE LUMEN

7 Connect a syringe containing sterile saline to an appropriately size flushing needle. Carefully apply the
needle to the distal tip of the delivery system and flush the guidewire lumen.
8

Remove the syringe and the flushing needle.

CAUTION: Avoid excessive manipulation of the stent during flushing of the guidewire lumen.
9

Leave the prepared stent system at ambient pressure.

CAUTION: DO NOT apply negative pressure to the delivery system prior to placement of the stent across the
lesion. This may cause loosening and dislodgement of the stent.
INSERTION AND STENT POSITIONING
10 Attach a hemostatic valve to the luer-port of the guiding catheter positioned within the vasculature.
11 Position the guidewire under fluoroscopy in accordance with PCI techniques.
12 Back-load the proximal end of the guidewire into the distal tip of the delivery system until it exits at the
guidewire exit port.
13 Open the hemostatic valve completely.
CAUTION: A partially opened valve might damage the stent or dislodge it from the centered location on the
balloon.
14 Carefully insert the stent system through the hemostatic valve.
15 Advance the stent system through the guiding catheter using fluoroscopic guidance to determine when
the delivery system tip approaches the distal tip of the guiding catheter.
NOTE: The shaft exit markers on the hypotube may be used to approximate wen the stent system has reached
the distal end of the guiding catheter.
16 Carefully advance the stent system into the coronary artery over the guidewire while maintaining stable
guiding catheter seating and stable guidewire placement across the target lesion.
17 Position the stent within the lesion using the balloon radiopaque markers as reference points.
CAUTION: DO NOT apply excessive force whilst accessing or crossing the lesion. This may damage the stent
and/or dislodge it from the balloon. If resistance is felt at any time, stop the procedure and determine the
cause of resistance before proceeding. If the stent system is unable to reach or cross the lesion easily, the
procedure should be aborted. Refer to the section Removal of an unexpanded stent .
18 Verify the stent position via high resolution fluoroscopy to assure an adequate coverage of the lesion
including the proximal and distal margins.
REMOVE AIR FROM THE DELIVERY SYSTEM
19 Connect a three-way stopcock to the luer-lock of the catheter.

IFU1062 Rev. B 10/22/2016

20 Prepare and remove air from a 20ml capacity Inflation/deflation device according to manufacturers
recommendations and instructions.
21 Attach the inflation/deflation device containing 3ml of balloon inflation medium to the stopcock.
WARNING: Use only an appropriate balloon inflation medium (e.g. 50:50 mixture by volume of contrast medium
and saline). Never use air or any gaseous medium to inflate the balloon.
22 Open the stopcock so that an open fluid path between the catheter and the inflation/deflation device is
established.
23 Pull the plunger of the inflation/deflation device an aspirate air from the catheter for at least 30 seconds.
CAUTION: DO NOT inflate the balloon if a vacuum cannot be held, as this indicates a leak in the delivery system.
If a vacuum cannot be held, follow the instructions for the Removal of an unexpanded stent.
24 Close the stopcock so that the fluid path to the catheter is closed and evacuate all air from the
inflation/deflation device through the stopcock.
25 Repeat steps 22-24 if necessary, to ensure air contained in the balloon and inflation lumen are removed.
Release the inflation/deflation barrel to normal pressure.
9.0 DIRECTIONS FOR USE
STENT DEPLOYMENT
26 Inflate the balloon gradually to expand the stent to the calculated diameter in accordance with the
compliance chart. Hold that pressure for 15-30 seconds.
CAUTION: Inflate to at least the nominal pressure (NP) indicated on the label and the compliance chart. DO
NOT exceed Rated Burst Pressure (RBP)).
27 If necessary, the delivery system balloon may be dilated once more in order to achieve optimum seating of
the implanted stent.
28 If the stent is still not completely apposed to the vessel wall, the stent can be re-crossed and further
expanded with a larger balloon.
CAUTION: Avoid barotrauma outside the stent margins during subsequent dilatations.
CAUTION: DO NOT post-dilate the stent to more than the maximum expandable diameter recommended in
the compliance chart.
CAUTION: Exercise care when crossing a newly deployed stent with a coronary guidewire, balloon catheter or
stent system to avoid disruption of the stent geometry and stent migration.
BALLOON DEFLATION AND DELIVERY SYTEM REMOVAL
29 Deflate the balloon in accordance with standard PCI procedures. Apply negative pressure to the balloon
for at least 40 seconds. Before carefully pulling the delivery system out of the vessel.
30 If the balloon cannot be withdrawn from the stent easily, slightly advance and retract the delivery system
very carefully until it is possible to pull it out.
31 Under fluoroscopic control retrieve the delivery system carefully into the guiding catheter.
CAUTION: If resistance is encountered while doing so, remove the delivery system and the guiding catheter as a
single unit according to the instructions below.

IFU1062 Rev. B 10/22/2016

REMOVAL OF AN UNEXPANDED STENT

01 Make sure that the guiding catheter tip and the guidewire are aligned to avoid any acute angle between
the guidewire and guiding catheter tip.
02 Slowly pull back the stent system. The entry of the stent into the guiding catheter must be performed slowly
under fluoroscopic control to avoid dislodgement of the stent from its position on the delivery system
balloon.
CAUTION: If any resistance is felt while doing so, the stent system and the guiding catheter must be removed as
a single unit according the instructions below.
CAUTION: DO NOT RE-INSERT The Celosia Covered Coronary Stent System as the stent and/or the delivery
system may have been damaged during the initial attempt to cross the lesion or during withdrawal.
Removal of the stent system and the guiding catheter as a single unit
01 Position the proximal balloon marker just distal to the tip of the guiding catheter.
02 Advance the guidewire into the artery as distally as safely possible.
03 Tighten the hemostatic valve to secure the delivery system to the guiding catheter.
04 Remove the guiding catheter and the delivery system as a single unit.
10.0 REFERENCES
The physician should consult recent literature on current medical practice on stenting, such as that published
by ACC/AHA.

M
InSitu Technologies, Inc.
539 Phalen Boulevard
St. Paul, MN
Tel 651 389 1017
Fax 651 305 1089
FDA Registered Facility
ISO 13485 Certified
For International Distribution
DISCLAIMER
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ON THIS ITEM. PRODUCT(S) DESCRIBED IN THIS PUBLICATION UNDER NO
CIRCUMSTANCES SHALL BE LIABLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OTHER THAN AS
EXPRESSLY PROVIDED BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY TO BIND INSITU TO ANY REPRESENTATION
OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH HEREIN.
Descriptions or specifications in InSitu Technologies printed matter, including this publication, are meant solely
to generally describe the product at the time of manufacture and do not constitute any express warranties.

IFU1062 Rev. B 10/22/2016

COMPLIANCE CHART
Celosia Covered Coronary Stent System
Table A: Stent Compliance
Celosia Compliance Chart
Diameter(mm)
2.75
3.0
3.5
4.0

(ATM)

2.0

2.25

2.5

6
7
8
9
10
11
12
13
14
15

2.0
2.04
2.07
2.11
2.14
2.18
2.22
2.26
2.29
2.34

2.25
2.29
2.32
2.35
2.37
2.40
2.42
2.44
2.46
2.49

2.50
2.54
2.57
2.60
2.63
2.66
2.68
2.71
2.73
2.76

2.75
2.79
2.83
2.86
2.89
2.92
2.95
2.97
3.00
3.03

3.00
3.06
3.11
3.15
3.18
3.21
3.24
3.27
3.30
3.32

3.50
3.57
3.63
3.68
3.72
3.76
3.79
3.82
3.85
3.87

16

2.39

2.51

2.78

3.06

3.34

3.89

4.5

5.0

6.0

7.0

4.00
4.10
4.16
4.20
4.27
4.31
4.34
4.38
4.41
4.43

4.50
4.55
4.59
4.64
4.68
4.73
4.78
4.82
4.87
4.92

5.00
5.05
5.10
5.15
5.20
5.26
5.31
5.36
5.41
5.47

6.00
6.06
6.12
6.18
6.24
6.31
6.37
3.43
6.50
6.56

7.00
7.07
7.14
7.21
7.28
7.36
7.42
7.49
7.56
7.63

4.45

4.97

5.52

6.63

7.70

Table B: Device Specifications

**In Vitro
*Minimum
*Minimum Guide
Stent
Stent
Guide Catheter
Catheter
Nominal
Rated Burst
Diameter
Compatibility
Compatibility
Pressure Pressure (mm)
Stent Length
(mm)
(OD)
(ID)
NP (atm)
RBP (atm)
2.25
5, 10, 13, 16, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
2.5
5, 10, 13, 16, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
2.75
5, 10, 13, 16, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
3.0
5, 10, 13, 16, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
3.5
5, 10, 13, 16, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
4.0
5, 10, 13, 16, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
4.5
5, 10, 13, 15, 19, 23, 26, 30, 34, 38
5F
0.056" / 1.4mm
6
16
5.0
17, 20, 27, 30, 34, 40
6F
0.070" / 1.78mm
6
16
6.0
17, 20, 27, 30, 34, 37
6F
0.070" / 1.78mm
6
16
7.0
14, 17, 23, 28, 33
6F
0.070" / 1.78mm
6
16
*See individual manufacturer for French equivalent
**Assure full deployment of the stent. Deployment pressures should be based on lesion characteristics.

IFU1062 Rev. B 10/22/2016