Glubran 2 Seal
KIT GLUBRAN 2 SEAL
New extravascular device for occlusion of the
femoral arterial access site.
The Kit is made up of Glubran 2 glue and its applicator “Glubran 2 Seal
Device”.
At present, “Glubran 2” glue is the occlusion system recommended after
procedures such as diagnostic and interventional catheterization through femoral
retrograde and antegrade access.
“Glubran 2” glue is used to occlude arterial access sites in an unique and
revolutionary method, absolutely innovative with regard to those used up to
today. The procedure is simple, quick and extremely safe for its control in
releasing under scopy.
GLUBRAN 2 SEAL DEVICE applicator
“Glubran 2 Seal Device” is the applicator specially
studied to be hooked and made slipping along the outer surface of the introducer
sheath , to go easily through the subcutaneous adipose tissue and to stop itself
into the point where the glue is released.
The applicator is in 5-6 French and 7-8 French sizes.
Advantages
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occlusion of the femoral access site in retrograde and antegrade position
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release of the glue in extravascular site
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no need to interrupt the anticoagulant therapies
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fast and safe occlusion due to the remarkable reactivity and adhesiveness
of the glue
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reduction of any infections connected to the bacteriostatic activity of the
glue
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biocompatible
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guarantees the occlusion of the femoral access site even when the
application is in the femoral artery, deep or superficial, femoral
bifurcation, by-pass (PTFE, Dacron, venous) and calcific vessels
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opportunity to immediately repunching the artery
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requires a short learning curve
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earlier patient’s walking activity
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reduction of hospital stay costs due to the early discharge of the patient
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execution of the procedure in complete safety by carefully following the
application steps
Glubran 2 Seal - Technical card
FEATURES
The Glubran 2 Seal Device consists of a steel cannula (1) with a luer-lock
attachment in polyamide at its proximal end (2), which is connected to the
syringe filled with Glubran 2, and a slide in polypropylene (3) at its distal end for
hooking to the vascular introducer.
The applicator is radiopaque and comes in sizes of 5-6 French and 7-8 French.
INDICATIONS
To be used in haemostasis procedures with Glubran 2 glue during the removal of
introducers in femoral endovascular percutaneous procedures.
USE: DESCIPTION
"Glubran 2" glue is delivered by the "Glubran 2 Seal Device" applicator along the
outer surface of the procedural sheath, in the area between the fascia and the
femoral artery. Since the sheath is inside the artery, the glue cannot accidentally
enter the lumen of the vessel.
The radiopacity of the applicator, combined with the prior injection of contrast
medium in the applicator itself, allows for the correct release of the glue in the
tissue below the fascia, over the arteriotomy site.
The immediate reaction of the glue with the tissue below the fascia provides a
perfect occlusion of the arteriotomy, ensuring a greater patient comfort and an
early ambulation.
The applicator and the procedural sheath have to be removed together, without
modifying the traditional procedure of sheath removal. The manual compression
has to be maintained for 3 minutes only and without interruption.
Correct position of the applicator with
regard to the fascia and to the
arteriotomy in a procedure with
retrograde access
Correct position of the applicator with
regard to the fascia and to the
arteriotomy in a procedure with
antegrade access
METHOD OF USE
STEP 1 - Withdraw the introducer to create the
necessary space for attaching the applicator
(approx. 2 cm). (PHOTO 1)
If the walls of the introducer have collapsed,
reinsert the persuader into the introducer before
attaching the applicator. (PHOTO 2)
STEP 2 - Make a 1cm cut in the skin (scalpel 11),
taking care to dissect the subcutaneous fibrous
layers surrounding the introducer (PHOTOS 3 / 4)
with the blade, moving from the bottom to the top.
STEP 3 - Attach the applicator to the introducer as
follows: place the index and middle fingers of your
hand under the introducer as a support base. Press
down on the applicator so that it attaches to the
introducer from the front end.
(PHOTOS 5 / 6)
STEP 4 - Move the applicator forward: hold the
introducer in place with one hand while the first
finger of the other hand presses down on the
applicator connector (PHOTO 7).
A significant increase in resistance is noticed as soon
as the tip of the applicator meets the fascial plane:
at this point, stop pressing (PHOTO 8).
STEP 5 - Find the position of the applicator
(radiopaque):
a) in relation to the artery, with an arteriography
(PHOTOS 9 /10)
b) in relation to the fascia by injecting 0.1 ml of
contrast medium in the applicator.
If the contrast medium spreads below the muscle
fascia, the applicator was positioned correctly.
(PHOTOS 11 / 12)
WARNING: If the contrast medium spreads above the
muscle fascia, push the applicator further in and
repeat the injection of the contrast medium until
the correct position is obtained.
STEP 6 - Draw up 0.20 ml of glue in a 1 ml syringe
with luer attachment.
(PHOTOS 13 / 14)
STEP 7 - Screw the syringe to the applicator (PHOTO
15)
STEP 8 - Inject the glue slowly and continuously.
(PHOTO 16)
WARNING: If injected too quickly, the glue could
flow back.
Distribution of the glue between the fascia and the
artery in a procedure with retrograde access (PHOTO
17) and anterograde access. (PHOTO 18)
STEP 9 - At the end of the injection, the applicator
and introducer must be immediately removed
together by grasping them with one hand. (PHOTO
19)
At the same time, perform the manual compression
according to the traditional method, holding it for 3
minutes without interruption. (PHOTO 20)
ADVANTAGES
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the haemostatic and adhesive properties of Glubran 2 allow for the
occlusion of the femoral access site in both the retrograde and antegrade
positions
release of the glue in extravascular site
no need to interrupt anticoagulant therapies
does not require the use of guides and there is no need to replace the
procedural sheath
fast and safe occlusion due to the remarkable reactivity and adhesiveness of
the glue with the tissues, blood and body fluids
reduction of any infections connected to the procedure due to the
bacteriostatic activity of the glue
biocompatible
the radiopacity of the applicator coupled with the possibility to inject
contrast medium, makes the application completely radiological, allowing
for the treatment of particularly complex cases such as atypical femoral
access, very thin or obese patients
guarantees the occlusion of the arteriotomy even when applied to deep or
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superficial femoral arteries, femoral bifurcation, by-pass (PTFE, Dacron,
venous) and calcific vessels
opportunity to immediately re-puncture the artery
requires a short learning curve
earlier ambulation, improved patient comfort
reduction of hospital stay costs
totally safe procedure when following the application guidelines
CONTRAINDICATIONS
There are no contraindications in the use of the device.
WARNINGS
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The safety and efficacy of the device has not yet been established in
patients with blood pressure above 180/110mmHg. In case of systolic blood
pressure values greater than or equal to 180, administer anti-hypertensive
medication and reduce the pressure before applying the device. In these
cases, apply a compressive bandage.
The safety of the device has not yet been established in patients with
underlying systemic or cutaneous infections.
The safety of the device has not yet been established in pregnant and
lactating patients.
The safety of the device has not yet been established in patients with heavy
bleeding from the access site of the introducer. (to informal Preliminary
studies have obtained good results when the glue is injected together with
0.1 ml of Lipiodol (contrast medium), which prevents it from consolidating
inside the device.
The device must not be used in patients with significant scarring in the
puncture site.
The radiopacity of the product also allows positioning of the slide under
fluoroscopic control. In this way, particularly in case of obese patients or
atypical femoral accesses, the slide can be positioned in complete safety by
monitoring the distance from the arterial plane.
Do not use the device in patients undergoing percutaneous procedures with
introducers smaller than 5 French or larger than 8 French.
The proper functioning of the product is only guaranteed with percutaneous
introducers whose outside diameters fall within the declared French
tolerances.
The device must not be used with introducers that have a rough surface.
Do not use if the packaging or device is open or damaged.
The device cannot be reused or re-sterilised.
The Glubran 2 Seal must not be used in patients who are sensitive to
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Glubran 2 glue.
The descent of the device along the introducer must be interrupted when it
meets resistance caused by contact with the fascia. 0.1 ml of contrast
medium must always be injected; if the contrast medium is distributed
between the fascia and the artery, then the glue can be injected. If the
contrast medium spreads above the fascia, the device must be pushed in
further and a new bolus of 0.1 ml of contrast medium must be injected to
check the correct positioning.
The medical device must only be used by trained personnel.
INTERACTIONS
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Do not apply the active ingredient, Ipamidol, radiological iodinated contrast
medium (Iopamiro, injectable solution) because it may inactivate the
properties of the Glubran 2 glue.
The mixing of Glubran 2 with the Lipiodol contrast medium delays the start
of the polymerisation process.
STORAGE
Temperature between 0°C and +4°C
PRODUCT CODE
KIT G2-SL 5/6
KIT G2-SL 7/8
CLASS
Medical Device - class IIa, certified CE 0476